healthcare Pressreleases

Boston Scientific Announces Japanese Approval for TAXUS(R) Liberte(R) Drug-Eluting Stent System

Fri, 30 Jan 2009 12:52:00 GMT

Product is Japan's first second-generation drug-eluting stent

Boston Scientific Corporation (NYSE: BSX ) announced today that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System. The Company plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.

TAXUS Liberte is the only second-generation drug-eluting stent approved for use in Japan. Design improvements over the Company's first-generation TAXUS® Express2(TM) Stent include thinner struts to allow better stent deliverability and conformability, as well as a more uniform stent geometry for consistent lesion coverage and drug distribution.

"The TAXUS Liberte Stent is the latest advance in drug-eluting stent technology for Japan," said Donald Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "Its safety and efficacy have been well demonstrated in multiple clinical studies and years of clinical use."

"We are very pleased with this approval, which provides access to proven technology to Japanese physicians and their patients," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We are committed to continuing to provide the most innovative products and therapies to the Japanese market."

The TAXUS Liberte Stent uses proven paclitaxel-eluting technology, which has been evaluated by the industry's most extensive randomized, controlled clinical trial program, and studied in 35,000 real-world patients enrolled in post-approval registries. More than 4.6 million TAXUS Stent Systems have been implanted globally.

The TAXUS Liberte Stent will replace the TAXUS Express2 Stent, which was launched in Japan in May 2007. It has been approved for sale in the United States, Europe and other international markets.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward- looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding regulatory approvals, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

Medtronic and Boston Scientific Reach Agreement on Patent Cases

Fri, 30 Jan 2009 12:52:00 GMT

Medtronic, Inc. (NYSE: MDT) and Boston Scientific, today announced settlements in two cases and an agreement to stand down in three other lawsuits. These agreements stop all current litigation between the two parties in the fields of interventional cardiology and endovascular repair. All the disputes were over intellectual property.

“Stopping this litigation allows us to focus our resources on the development of new products that will improve the quality of care for people with cardiovascular disease,” said Scott Ward, president of the CardioVascular business and senior vice president at Medtronic.

The stand down agreements are time limited and are only with Boston Scientific. Medtronic will continue litigation in two of the cases against Abbott Laboratories. While the terms of the settlement remain confidential, Medtronic advised that the above described agreements will not have a material impact on its financial results for its third fiscal quarter. The cases are listed below.

A. Medtronic Vascular, Inc., et al. v. Boston Scientific Corp., et al., No. 2:06-cv-00078-TJW-CMC, pending in the U.S. District Court for the Eastern District of Texas;

B. Boston Scientific Corp., et al. v. Medtronic, Inc., et al., No. 6:08-cv-320, pending in the U.S. District Court for the Eastern District of Texas;

C. Medtronic Vascular, Inc., et al. v. Boston Scientific Corp., et al. and Abbott Laboratories, et al., No. 2:08-cv-00318-TJW, pending in the U.S. District Court for the Eastern District of Texas;

D. Medtronic Vascular, Inc., et al. v. Abbott Cardiovascular Systems, Inc., et al., No. C-06-01066 (PJH), pending in the U.S. District Court for the Northern District of California; and

E. Boston Scientific Corp., et al. v. Medtronic, Inc., et al., No. CV 08 3844 PJH, pending in the U.S. District Court for the Northern District of California.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Stanford Develops Imaging Technique to Catch Arthritis Early in Onset

Fri, 30 Jan 2009 12:52:00 GMT

You come into a doctor’s office with severe knee pain. The physician orders an MRI, which reveals substantial loss of cartilage—osteoarthritis, that is—in your knee joint. At this point, not much can be done beyond gulping down palliatives and trying to keep your weight off the joint. But the damage may have started building as much as 20 years earlier, possibly due to a traumatic injury to the affected joint.
Just ask Garry Gold, MD, an associate professor of radiology at the Stanford University School of Medicine. Now 45, Gold sustained a knee injury 20 years ago while playing in a pickup basketball game. These days, he’s starting to wish his house, currently being remodeled, didn’t have any stairs.

Gold, who has been diagnosed with osteoarthritis, is working with an imaging technology called sodium MRI to diagnose osteoarthritis as long as decades before the onset of physical symptoms. That may spawn new therapies that could possibly have blocked his disease before it put an end to his basketball days.

Gold is collecting young athletes who’ve suffered damage to the anterior cruciate ligament, or ACL, in their knee—an injury afflicting several hundred thousand people annually in the United States alone. This knee insult is especially common among female athletes. “A good fraction of the Stanford women’s basketball and soccer teams either have torn their ACL sometime in the past or will tear it while they’re still at Stanford,” Gold said. Even when the initial ligament lesion is repaired surgically, victims remain at almost doubled risk for symptomatic osteoarthritis in the injured knee a decade or two down the road, compared with uninjured people.

Using the new imaging technology, Gold and colleagues have been able to spot, soon after such an injury, telltale signs of cartilage deterioration consistent with the development of osteoarthritis.
MRI now in routine use works by pulsing the area to be observed with electromagnetic energy, at a frequency that preferentially excites the protons in water molecules. As the protons settle back to a relaxed state, they send out an electromagnetic burst of their own, which can be picked up by sensors in the apparatus. Because cartilage has lots of water compared with nearby bone, it shows up on a computer-generated image of the region.

But while standard MRI gives a reasonable display of overall cartilage structure, it doesn’t tell a diagnostician much about the quality of that cartilage.

“If you look into a big house and you see that it’s standing up,” Gold said, “you may assume it’s going to be safe in the event of an earthquake. But without closer inspection, you don’t know much about the integrity of the structure.”

If standard MRI is akin to a view of standing timber in the house, the version Gold is using, called sodium MRI, enables the visualization of dry rot infecting and weakening the wood.
A key structural material in cartilage, called glycosaminoglycan, occurs in a complex with sodium, an elemental metal that has its own set of excitation and relaxation frequencies and is more restricted to cartilage than water is.

Sodium MRI has been around for years, but until recently it couldn’t be used in clinical settings. For one thing, the magnets employed to excite sodium atoms were too puny, making crisp resolution possible only with tiny creatures such as mice. Gold and his colleague Brian Hargreaves, PhD, assistant professor of radiology at Stanford, have designed improved magnets and software to scale up the technology for human application.

They’re on the right track, said Ari Borthakur, a University of Pennsylvania scientist who is not involved in Gold’s research but has done pioneering work with sodium MRI since writing his PhD thesis on it some years ago. “Everything his lab has developed is going to be applicable in the clinics,” said Borthakur. “As America ages, we’re expecting to see a huge increase in osteoarthritis, and any technique that could be used for its early diagnosis, or that could help developing therapies for curing it, or even slowing the progression of cartilage loss, would be tremendous.”

Gold and Hargreaves’ project is being conducted with funding from the National Institutes of Health and GlaxoSmithKline, an international pharmaceutical company. Neither researcher owns stock in, or receives consulting fees from, the company.

Working with Hargreaves, Gold has imaged the knees of about a dozen volunteers who have suffered a recent ACL injury. In every case so far, significant losses of glycosaminoglycan can be glimpsed under sodium MRI scanning, despite the absence of any sign of damage to cartilage observed with standard MRI. Almost invariably, sodium MRI scans of the injured knee—but not of the other, uninjured one—reveal glycosaminoglycan deficits within three years of the injury, potentially enabling a vastly accelerated diagnosis.

This ought to speed the development of new therapies, and radically lower the cost of doing so, Gold said. The idea is to be able to use glycosaminoglycan loss as a “surrogate marker” of impending osteoarthritis, much as high LDL levels are used to flag people at risk of heart disease—perhaps years before actual symptoms of heart disease manifest. While not everybody with elevated LDL develops cardiovascular disease, this marker has been sufficiently predictive of that condition that regulatory authorities routinely approve drugs based on their ability to lower LDL.

Catching osteoarthritis during its stealth phase may spur clinical trials that would be prohibitively time-consuming and costly if standard MRI were employed, because of the huge lag from the time of an ACL injury until the time cartilage deterioration can be detected by that old method.

With sodium MRI, cohorts of treated vs. untreated at-risk patients could be imaged over time to see if, within a few years of the injury, a drug or a lifestyle change is reducing or arresting the loss of glycosaminoglycan from the ligament. Once promising drugs or lifestyle changes are identified, they could then be administered to at-risk patients long before symptoms surface, Gold said.
As for Gold himself, he has yet to see what his own damaged knee looks like under sodium MRI. The 6-foot-6 once-avid amateur basketball center’s knee is too big for even his improved new experimental apparatus to fit. It’s probably too late for any kind of imaging to do Gold much good now, anyway. He already knows he’s got arthritis. “I don’t even want to look,” he said.

(NOTE TO REPORTERS: A video about the sodium MRI technique is available online athttp://med.stanford.edu/news_releases/2009/january/sodium.html)

Stanford University Medical Center integrates research, medical education and patient care at its three institutions — Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children’s Hospital at Stanford. For more information, please visit the Web site of the medical center’s Office of Communication & Public Affairs at http://mednews.stanford.edu.

Zoll Receives Clearance to Market New R Series BLS and R Series Plus Defibrillators

Fri, 30 Jan 2009 12:52:00 GMT

Open System Helps Ensure Code Readiness

ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of resuscitation devices and related software solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell the new ZOLL R Series® BLS and R Series Plus defibrillators. Shipments of the units began in December 2008.

The new R Series BLS and R Series Plus are designed to extend simple, smart and ready defibrillation to every hospital department with advanced, cost-effective solutions for resuscitation. The R Series BLS is a simple, easy-to-use AED that becomes a full-featured, advanced life support device for critical care at the touch of a button. The R Series Plus, which has both AED and ALS capabilities at the touch of a button, also has networking capabilities and See-Thru CPR®, which allows the professional rescuer to view a patient’s underlying cardiac rhythm during resuscitation efforts without the need to stop compressions to see if defibrillation was successful. Like all other ZOLL defibrillators, these models provide the Real CPR Help® feature that provides real-time feedback on the rate and depth of chest compressions. Both the BLS and Plus models have full CE marking and are available in English, French, Italian, German, Danish and Finnish.

The original R Series ALS, launched in November 2006, and these two new models, all use the same uniform operating system common to ZOLL defibrillators. The cables, paddles, batteries, handles, and electrodes are also common to ensure that clinicians will not encounter a mismatch during a code.

In addition, all R Series models can use wireless networking to ensure code-readiness. Based on standard 802.11b WiFi technology, the R Series automatically sends a status of its state of readiness at a programmed time. Early notification maximizes patient safety by letting the clinician intervene before the defibrillator is needed for a code.

While defibrillators rarely fail, their readiness can be compromised if someone forgets to plug it in, a cable is missing, or the electrodes are old and dried out. With WiFi, when the state of readiness is compromised, an automated notification can help restore code readiness with unmatched efficiency by troubleshooting from any PC on the hospital network.

“ZOLL’s advanced technology in the R Series platform helps ensure readiness any time a code occurs,” said Richard A. Packer, Chairman and Chief Executive Officer of ZOLL. “Since defibrillators are widely distributed throughout hospitals, and their use is both infrequent and extremely critical, code readiness helps clinicians save more lives.” ZOLL R Series: Simple, Smart, Ready

The R Series is a Code-Ready® device that is simple, smart, and ready to use. It offers a OneStep™ system to simplify and speed up deployment of pacing and defibrillation therapy. It also offers smart tools to help clinicians improve CPR performance, which is important since more than half of in-hospital codes involve non-shockable rhythms and, in such cases, the only treatment is high-quality CPR with minimal interruptions.

The R Series can also verify the condition and expiration date of the electrode set. All of this testing occurs without disconnecting electrodes or paddles, or requiring additional equipment to test shock delivery. The system provides a printed or electronic log to alert hospital personnel of any concerns in advance of a code. A simple green checkmark indicates that the R Series is fully ready for use. About ZOLL Medical Corporation

ZOLL Medical Corporation is committed to developing technologies that help advance the practice of resuscitation. With products for pacing, defibrillation, circulation, ventilation, and fluid resuscitation, ZOLL provides a comprehensive set of technologies, including Real CPR Help® and See-Thru CPR®, that help clinicians, EMS professionals, and lay rescuers resuscitate sudden cardiac arrest or trauma victims. ZOLL also designs and markets software that automates the documentation and management of both clinical and non-clinical information.

ZOLL markets and sells its products in more than 140 countries. The Company has direct operations, distributor networks, and business partners throughout the U.S., Canada, Latin America, Europe, the Middle East and Africa, Asia, and Australia. 2008 marks the 25th anniversary of ZOLL’s resuscitation product development. For more information, visit www.zoll.com.

Certain statements contained in this press release, including statements regarding the future business of the Company, and other statements contained herein regarding matters that are not historical facts, are “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those factors discussed in the section entitled “Risk Factors” in the Company's Annual Report on Form 10-K filed with the SEC on December 8, 2008. You should not place undue reliance on the forward-looking statements in this press release, and the Company disavows any obligation to update or supplement those statements in the event of any changes in the facts, circumstances, or expectations that underlie those statements.

Copyright © 2009 ZOLL Medical Corporation. All rights reserved. 269 Mill Road, Chelmsford, MA 01824-4105. ZOLL, AED Plus, AED Pro, E Series, Real CPR Help, and See-Thru CPR are registered trademarks of ZOLL Medical Corporation.

Given Imaging Announces Expansion of Distribution Relationship With FUJIFILM

Fri, 30 Jan 2009 12:52:00 GMT

FUJIFILM to Begin Selling PillCam(R) Product in Japan as of January 2009

Given Imaging Ltd. (NasdaqGM:GIVN ) today announced the expansion of its relationship with FUJIFILM Corporation by entering into an agreement with FUJIFILM Medical Co. Ltd., a fully owned subsidiary of FUJIFILM, to distribute Given Imaging's PillCam® SB product line in Japan as of January 20th, 2009. FUJIFILM already distributes PillCam SB in certain countries, including China, and has collaborated with Given Imaging in research and development since 2007.

"We are pleased to expand our relationship with FUJIFILM, a worldwide leader with a proven track record in the endoscopy market," said Homi Shamir, President and CEO of Given Imaging. "We believe that this partnership will provide excellent care for those patients suffering from gastrointestinal disorders in Japan. With both Suzuken and FUJIFILM Medical acting as distributors of the Company's products for the small bowel in Japan, we can expand our footprint and sales in the promising Japanese market. In addition, FUJIFILM's Double Balloon endoscope, launched in 2003 to treat diseases of the small bowel, is the perfect complement to Given Imaging's capsule endoscopy."

"The combination of FUJIFILM's Double Balloon endoscopy with Given Imaging's PillCam SB provides a very effective diagnostic and therapeutic solution to physicians for treating small bowel disorders," said Hisatoyo Kato, president and CEO of FUJIFILM Medical Co. "We are also thrilled by the prospects of connecting the output of these two devices to the Hospital Information Systems through our 'nexus sif' filing system."

About Given Imaging

Since 2001 Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam SB, the esophagus through PillCam ESO and the colon with PillCam COLON [not cleared for use in the USA]. The PillCam capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). Given Imaging's products use cutting-edge wireless technology and advanced software to enable gastroenterologists to better diagnose and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia and Singapore. For more information, please visit http://www.givenimaging.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) our ability to develop and bring to market new products, (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of significant litigation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2007. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

Advanced Medical Optics Receives FDA Approval for TECNIS(R) Multifocal Intraocular Lens

Fri, 30 Jan 2009 12:52:00 GMT

Designed To Provide Cataract Patients High-Quality Near And Distance Vision In A Range Of Light Conditions

Advanced Medical Optics, Inc. (AMO) (NYSE:EYE), the global leader in advanced refractive technologies for eye care professionals and patients, today announced U.S. Food and Drug Administration (FDA) approval of the TECNIS(R) Multifocal intraocular lens (IOL) for cataract patients.

The TECNIS(R) Multifocal IOL's unique design gives patients superior near vision and reading speed compared to other presbyopia-correcting IOLs, as well as exceptionally high spectacle independence, with nearly 9 out of 10 patients reporting that they never wear glasses after surgery.

Other features/benefits include:

-- high-quality vision for near, far and intermediate distances, day or night;

-- first and only pupil-independent, non-apodized fully diffractive aspheric lens designed to correct the two highest order aberrations - spherical and chromatic - to give patients back their youthful vision;

-- 95 percent patient satisfaction - the highest of any presbyopia-correcting IOL.

"The TECNIS(R) Multifocal IOL delivers a predictable and consistent full range of vision," said Ralph Chu, M.D., founder and director of the Chu Vision Institute in Bloomington, Minn. "The U.S. clinical study shows that more than 94 percent of patients function comfortably without glasses for all distances, including intermediate. More importantly, my own patients are highly satisfied with the results."

"The full diffractive surface of the TECNIS(R) Multifocal IOL provides high-quality vision largely independent of pupil size and reduces chromatic aberration for better image quality," said Manfred Tetz, M.D., professor of ophthalmology and director of Eye-Center-Spreebogen, Berlin, Germany. "I have been implanting the TECNIS(R) Multifocal IOL since 2003 because of the high-quality visual results that I can provide for my patients, who report being extremely satisfied with their vision."

"The introduction of the TECNIS(R) Multifocal IOL in the U.S. rounds out AMO's portfolio of market-leading, refractive technologies," said AMO Chairman and CEO Jim Mazzo. "Following years of success in Europe, U.S. surgeons will soon be able to pass the benefits of this technology on to their patients."

TECNIS(R) Multifocal IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The IOLs are intended to be placed in the capsular bag.

AMO plans to ship TECNIS(R) Multifocal IOLs to U.S. surgeons in early 2009.

About Advanced Medical Optics (AMO)

AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. Products in the cataract line include monofocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as Tecnis(R), Clariflex(R) and Sensar(R) IOLs; Sovereign(R), Sovereign(R) Compact and WhiteStar Signature(TM) phacoemulsification systems with WhiteStar(R) technology; Healon(R) viscoelastics and the Baerveldt(R) glaucoma shunt. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards, and refractive implants. AMO brands in the refractive business include iDesign(TM), iFS(TM), Star S4 IR(R), WaveScan Wavefront(R), Advanced CustomVue(TM), IntraLase(R), IntraLasik(R) and ReZoom(R), Tecnis(R) Multifocal and Verisyse(R) IOLs. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears. Among the eye care product brands the company possesses are COMPLETE(R), COMPLETE(R) Blink-N-Clean(R), Consept(R)F, Consept(R) 1 Step, Oxysept(R) 1 Step, UltraCare(R), Ultrazyme(R), Total Care(TM) and blink(R) branded products. AMO is based in Santa Ana, California, and employs approximately 3,700 worldwide. The company has operations in 27 countries and markets products in approximately 60 countries. For more information, visit the company's Website at www.amo-inc.com.

Forward-Looking Statements

This press release contains forward-looking statements about AMO, including statements by Dr. Chu, Dr. Tetz and Mr. Mazzo, and statements relating to expected product performance and anticipated outcomes, as well as expected shipment dates. All forward-looking statements in this press release represent AMO's judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors. Therefore, the reader is cautioned not to rely on these forward-looking statements. AMO disclaims any intent or obligation to update these forward-looking statements. Additional information concerning these and other risk factors may be found in previous press releases issued by AMO and AMO's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in AMO's 2007 Form 10-K filed in March 2008 and its Form 10-Q filed in November 2008. Copies of press releases and additional information about AMO are available at www.amo-inc.com.

A Milestone in Cancer Genetics: deCODE Discovers First Common Genetic Variants Affecting the Risk of Many Types of Cancer

Fri, 30 Jan 2009 12:52:00 GMT

Findings point to common mechanisms of susceptibility to cancers of the lung, bladder, prostate, cervix and skin; findings to be integrated into deCODEme(TM), the new deCODEme Cancer Scan(TM), and deCODE's DNA-based risk diagnostic tests

Scientists at deCODE genetics (Nasdaq: DCGN) and colleagues from the US and ten European countries today announced a long-awaited first in cancer research: the discovery of common single-letter variations in the human genome (SNPs) linked to susceptibility not of one, but several different types of cancer, including those of lung, bladder, prostate, skin and cervix.

Over the past two years, deCODE has led a wave of discoveries by scientists around the world of common SNPs conferring risk of many major types of cancer. Yet without exception, these SNPs have been linked to cancer of only one or at most two tissue types or organs. The SNPs published today, located near each other on chromosome 5p15, may therefore help to tag major biological mechanisms underlying cancer susceptibility more generally. The paper, entitled "Sequence variants at the TERT-CLPTM1L locus associate with many cancer types," is published today in the online edition of Nature Genetics at www.nature.com/ng, and will appear in an upcoming print edition of the journal.

"Today's findings demonstrate the power of using genetics to advance our understanding of the biology of cancer and to discover new strategies for assessing and reducing risk. Our next task is to discover how these SNPs affect susceptibility. One plausible, but as yet unproven, explanation is that these variants provide a genetic background that determines how our bodies respond to environmental risk factors. A thread connecting these different cancer types is that most have important known environmental risk factors and all tend to arise in the tissue layers directly exposed to the environment. One of the SNPs we have discovered is in a gene involved in determining the length of the telomeres, or the tail ends of chromosomes. Shorter telomeres have recently been linked to risk of certain cancers, and telomeres are known to become shorter with the accumulation of environmental insults over time. These findings may point us towards a means of addressing these risks by altering our lifestyle or by helping to identify targets for new drugs. We are integrating the SNPs into deCODEme(TM), and into our deCODEme Cancer Scan(TM) launched today," said Kari Stefansson, CEO of deCODE and senior author on the paper.

deCODE discovered the first variant, a SNP called rs 401681, in its gene discovery work on basal cell carcinoma (BCC), a common form of skin cancer. The SNP is in the gene encoding cisplatin resistance related protein 9 (CLPTM1L). Because the region of chromosome 5p15 is of interest in cancer biology, the deCODE team then tested this SNP for association with 16 different types of cancer in a total of nearly 80,000 cancer patients and healthy control subjects from Iceland, the Netherlands, Italy, Sweden, Spain, Germany, Hungary, the United Kingdom, Belgium,Romania, Slovakia and the United States. Rs 401681 was found to confer increased risk not only of BCC, but also cancer of the lung, bladder, prostate and cervix, and was also found to protect against melanoma. It is of interest here that the risks of cancers of lung, bladder, prostate and cervix are greater in individuals with shorter telomeres than long, whereas those with long telomeres are at greater risk of melanoma. Through a more detailed analysis of this region, another SNP, rs2736089, was associated with increased risk of BCC and also with risk of cancer of the lung, bladder and prostate. Rs 2736089 is located in the gene encoding the human telomerase reverse transcriptase (TERT), which directs the addition of repeat DNA sequences to the ends of chromosomes. Importantly, the risk of these different cancers conferred by these two SNPs appears to be independent.
Acknowledgments

deCODE thanks the many thousands of individuals who participated in this study, as well as the collaborating researchers and institutions. This study was funded in part by the European Commission through the POLYGENE (LSHC-CT- 2005-018827) and GENADDICT (LSHM-CT-2004-005166) grants; by the US National Institutes of Health (R01-DA017932); a research investment grant of the Radboud University Nijmegen Medical Centre; and through numerous grants to collaborating institutions.

About deCODE

deCODE is a bio-pharmaceutical company developing drugs and DNA-based tests to improve the treatment, diagnosis and prevention of common diseases. Its lead therapeutic programs, which leverage the company's expertise in chemistry and structural biology, include DG041, an antiplatelet compound being developed for the prevention of arterial thrombosis; DG051 and DG031, compounds targeting the leukotriene pathway for the prevention of heart attack; and DG071 and a platform for other PDE4 modulators with therapeutic applications in Alzheimer's disease and other conditions. deCODE is a global leader in human genetics, and has identified key variations in the genome (SNPs) conferring increased risk of major public health challenges from cardiovascular disease to cancer. Based upon these discoveries deCODE has brought to market a growing range of DNA-based tests for gauging risk and empowering prevention of common diseases. Through its CLIA-registered laboratory, deCODE is offers deCODE T2(TM) for type 2 diabetes; deCODE AF(TM) for atrial fibrillation and stroke; deCODE MI(TM) for heart attack; deCODE ProstateCancer(TM) for prostate cancer; deCODE Glaucoma(TM) for a major type of glaucoma; and deCODE BreastCancer(TM), for the common forms of breast cancer. deCODE is delivering on the promise of the new genetics(SM). Visit us on the web at www.decode.com; on our diagnostics site atwww.decodediagnostics.com; for our pioneering personal genome analysis service and focused disease scans, integrating the genetic variants included in these tests and those linked to another twenty common diseases, atwww.decodeme.com; and on our blog at www.decodeyou.com.

Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results, and the timing of events, to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, the effect of a potential delisting of our common stock from The Nasdaq Global Market, uncertainty regarding potential future deterioration in the market for auction rate securities which could negatively affect our cash position and result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10-K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.

Medtronic to Acquire Ablation Frontiers

Fri, 30 Jan 2009 12:52:00 GMT

Medtronic’s AF Solutions Franchise Will Include Radiofrequency Catheter Ablation Technologies for the Treatment of Atrial Fibrillation

Medtronic, Inc. (NYSE: MDT) and privately held Ablation Frontiers, Inc., today announced that the two companies have entered into an agreement whereby Medtronic will acquire Ablation Frontiers for an initial payment of $225 million plus potential additional payments contingent upon achievement of certain clinical milestones. The acquisition has been approved by Ablation Frontiers shareholders, and is subject to regulatory clearance. The transaction is expected to close in Medtronic’s fourth fiscal quarter, ending April 24, 2009.

“As the leader in cardiac rhythm disease management, Medtronic is well positioned to deliver innovative therapies and expand the marketplace to address unmet needs in atrial fibrillation,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Once the transaction is complete, we will add Ablation Frontiers’ emerging technologies to our growing AF Solutions franchise.”

The goal of Medtronic’s newly formed AF Solutions franchise, led by vice president and general manager Reggie Groves, is to be the physician partner of choice for atrial fibrillation (AF) ablation by bringing breakthrough AF therapies to the patients and physicians that are simpler, safer, effective, and offer more predictable procedure times than current treatment methods. Medtronic will offer physicians a choice of ablation therapies and tools to best meet the needs of their AF patients, as well as the needs of their practices.

Following Medtronic’s recent acquisition of CryoCath Technologies, Inc., a leader in cryoablation treatments for AF, the addition of Ablation Frontiers’ anatomically designed, catheter-based ablation technologies and its unique radiofrequency (RF) energy system will allow Medtronic to deliver the industry’s broadest range of therapies.

Keegan Harper, chief executive officer of Ablation Frontiers, said, “We are thrilled to join Medtronic and together will address the increasingly significant area of atrial fibrillation. We believe there is great value in aligning with a company that will offer a suite of distinct products that will provide physicians and their patients the best solutions for treating atrial fibrillation.”

In 2006, Ablation Frontiers received CE Mark to begin marketing its system of catheters and the RF generator in the European Union. Ablation Frontiers is conducting a clinical trial under a United States Food and Drug Administration (FDA) investigational device exemption (IDE) to gain approval for permanent, or chronic, AF in the U.S.

About Atrial Fibrillation

Atrial fibrillation (AF or A Fib) is an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart. Atrial fibrillation is the most common cardiac rhythm condition, found in approximately three million Americans and seven million people worldwide. An AF heart rhythm is significantly faster than a normal heartbeat and is a form of tachyarrhythmia (fast beating heart) and left untreated causes inefficient pumping of the heart that can lead to other serious health problems including stroke, chronic fatigue and congestive heart failure. Unfortunately most AF patients who currently receive drug therapy are non-responsive therefore could be indicated for ablation therapy.

About Ablation Frontiers

Ablation Frontiers, Inc. (www.ablationfrontiers.com), is a privately held medical device company based in Carlsbad, Calif. Founded in 2004, Ablation Frontiers is dedicated to helping individuals suffering from AF and other cardiac arrhythmias through the development and commercialization of innovative products designed to make ablation procedures safer and less time consuming, thereby making it possible for more individuals to benefit from this life-bettering therapy.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties. Medtronic cautions readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information. Forward looking statements include, but are not limited to, statements about the benefits of the acquisition, including future financial and operating results, post-acquisition plans, objectives, expectations and intentions and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the risk that the businesses will not be integrated successfully; the risk that the cost savings and any other synergies from the acquisition may not be fully realized or may take longer to realize than expected; disruption from the acquisition making it more difficult to maintain relationships with customers, employees or suppliers; and competition and its effect on pricing, spending, third-party relationships and revenues. Additional factors that may affect future results are contained in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results. Medtronic disclaims any obligation to update and revise statements contained in this release based on new information or otherwise.

China Med Synergizing with Growing Domestic Medical Industry

Fri, 30 Jan 2009 12:52:00 GMT

China Med 2009 is right around the corner to stage in this March. As the most influential fair in Chinese medical equipment industry, it is dedicated to building up a perfect interaction platform for China domestic medical organizations and global medical equipment suppliers, innovating in medical technologies, inducing industry growth and bettering people’s health and life quality.

Co-organized by the Health Department of General Logistics Department of Chinese People’s Liberation Army, China World Trade Center Co., Ltd., Hui Tong Xingye International Exhibition (Beijing) Co., Ltd. as well as Messe Düsseldorf China Ltd., China Med is also supported by international renowned organizations, such as the German Industry Association for Optical, Medical and Mechatronical Technologies, the Association for the Promotion of International Trade, Japan, and the World Forum for Medicine (MEDICA).

Launched in 1989, the annual China Med has been experiencing growth in scale and ever-increasing exhibitors. In 2008, hundreds of thousands of trade visitors streamed to the show, with deals concluded standing at 130 million USD. Occupying an area of 30,000m2 area , China Med 2008 embraced 537 exhibitors from 20 countries and regions. Apart from large equipments, medical consumables and orthopaedics related equipments were also staged on this exhibition. China Med 2009 will continue to invite reputed academicians and experts to address insight discussions on medical imaging equipments, digital medical imaging technology, medical logistics and many other topics. Besides, academic conferences on orthopaedic trauma, imaging diagnosis of tumor, clinical test, modern stereotactic technology and other fields will take place concurrently.

Characterized by profession, openness, concerning people’s livelihood and caring about patients, China Med mirrors the development of Chinese medical industry in last 20 years.

Profession: As technology-intensive industry, professionalism is always emphasized in medical industry. The medical equipment exhibition is more than viewing and amusing. According to official statistics of China Med, about 30% visitors come from domestic and oversea hospitals and medical research institutions and 60% visitors are wholesalers, agents and dealers of medical equipments. China Med 2009 will not only furnish large equipment showcasing zones for ultrasonography, biochemical and detection instruments, but also prepare special zones for medical consumables, orthopaedics related equipments, medical information and application, and so on.

Openness: Firstly, lots of business and academic exchanges are conducted each year for better serving the patients. China Med is to provide a platform for industry communication. Domestic specialists and experts will deliver speeches on large equipment quality evaluation, stereotactic technologies and other pioneering projects. As one of the host organizations, the Health Department of General Logistics Department of Chinese People’s Liberation Army will organize a visiting delegation to this exhibition, including 1,200 experts, doctors and users from the army , to view and learn about new products on site, also handing on tests of equipments, so as to provide primary information for bidding invitation and evaluation of military hospitals.

Secondly, with the further steps of reform and opening-up and globalization, China’s medical equipment industry enters the period of rapid growth. China has become the third largest medical equipment market in 2005, only after the United States and Japan. It is predicted by analysts to forerun Japanese market in the near future. China’s medical equipment import and export amounted to 10 billion USD in 2006, increased by 17.57% compared with the same period of the year before, while in 2007 the figure was refreshed to 12.697 billion USD, up 20.33%. China Med acts as the window of international medical industry as well as the portal of world medical organizations marching into China.

As medical care is an important part of social welfare, the government has been investing a lot in medical industry. However, only a small part of people can benefit from it as the investments were not utilized very well under the planning system. Besides, most domestic medical equipments are outdated. According to incomplete statistics, 15% of them were manufactured before 1970s, 60% in the early and middle 1980s. What’s more, these equipments are mainly in large cities, not well balanced, leading to astonishing lack in undeveloped areas, especially in rural areas. The national statistics in 2007 revealed that there were 298,400 medical organizations in the whole country, including 19,900 hospitals (incl. general hospital, hospital of traditional Chinese medicine and special hospital) and the rest were health centers and village health offices. Less than 7% hospitals have to undertake almost 58% of all treatments needed, far beyond their capacity.

The coming medical system reform will also generate great influence for medical equipment industry, though it mainly focuses on system renovation. Issue of new medical system reform combining measures for domestic demand expansion will definitely speed up the development of Chinese medical and healthcare industry, ushering in a new round of growth in medical equipment purchase. In addition, the central government has confirmed a 100 billion yuan investment, including 4.8 billion yuan for infrastructure construction, mainly for upgrading rural medical equipments and relevant resources, to further promote rural development as proposed in the Third Plenary Session of the Seventeenth Central Committee. Analysts believe this will obviously enlarge the market of economy equipment in medical sector.

China Med has always been caring about the illness treatment and needs of medical organizations in undeveloped areas and responding to the policies of the central government. In recent years, much attention is paid to the middle and low ends of the market. On one hand, China Med devotes itself to inviting the most exhibitors ,strictly controlling the quality ,and providing platform of economical type products. On the other hand, great efforts have been made to help medical organizations from undeveloped areas showcase as well as get to know about fair information more conveniently.

Global medical industry is undergoing the transformation from “disease-oriented” to “patient-oriented”. Michael Porter, leading strategist in the area of strategy, once commented that we were providing advanced medical technologies with outdated organizing and management. Medical equipments are only individual tools in an illness oriented model while pathology, technology and psychology systems will reasonably be integrated in a patient oriented model. Medical equipment suppliers should put themselves in medical workers’ position to check their products again.

China Med has become indispensable for bridging medical equipment suppliers and professional medical workers since its foundation. It tries to introduce more products with humanity design, encourage and help exhibitors to showcase not just individual products but general solutions. Communications on such issues will be involved on site, complemented with discussions in seminars.

The medical equipment industry will definitely rejuvenate, just like the financial crisis overturns the old financial structure. Medical system reform and global competition will be main challenges confronting this industry in 2009. China Med 2009 will absolutely be a great battle field for Chinese medical equipment industry.

For more information please visit: www.chinamed.net.cn.

Media Contact:
China World Trade Center Co., Ltd.

Ms. Yang Jing
Tel: (86 10) 6505 3552
Fax: (86 10) 6505 3260
E-mail: chinamed@cwtc.com

Messe Düsseldorf China Ltd.
Mr. Jansen Xu / Ms. Tina Qiu
Tel: (86 21) 5027 8128 / (86 23) 6292 7728
Fax: (86 21) 5027 8138 / (86 23) 6292 7738
E-mail: press@mdc.com.cn

Medegen Receives FDA Clearance for MaxGuard(TM) Advanced Luer-Activated Device with Antimicrobial Technology

Fri, 30 Jan 2009 12:52:00 GMT

First Positive Displacement Needleless Connector with Antimicrobial Technology

Medegen, a leading innovator in infusion therapy products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MaxGuard(TM) Advanced Luer Activated Device featuring Agion® Antimicrobial Technology. MaxGuard is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing has demonstrated this new antimicrobial device exhibits a kill rate of greater than 99.99 percent representing a 4+ log reduction on infection-causing organisms predominantly responsible for catheter related bloodstream infections.

Medegen routinely receives input from IV Therapy clinicians regarding unmet needs and new product concepts. In 2006 clinical end users requested that Medegen’s leading device, the MaxPlus® Positive Displacement Connector, be offered with a clear housing to facilitate visualization of the fluid path. In February 2008, Medegen released the MaxPlus Clear(TM) which quickly became a leading product for the company because of the consistent and dramatic bloodstream infection reduction results it has brought to hospitals nationwide. Last year MaxPlus clinical users requested an antimicrobial version of the MaxPlus Clear device for use on immunocompromised patients. Today, Medegen is once again fulfilling the clinical users’ requests by announcing FDA clearance of the new MaxGuard Advanced Luer Activated Device with Antimicrobial Technology.

"This is a significant achievement in Medegen’s ongoing pursuit to develop programs and products that help clinicians prevent bloodstream infections,” said Jeffrey Goble, President of Medegen. “Our goal has always been to provide clinicians with products that will significantly improve their efforts to enhance patient care and positive outcomes, and MaxGuard with Antimicrobial Technology meets that goal.”

Many hospitalized patients receive medications and nutritional support intravenously. During the process of administering intravenous medication, environmental contaminants can be introduced into the bloodstream. This is of particular concern if proper infection prevention techniques are not followed. MaxGuard with Antimicrobial Technology helps prevent contamination and growth of microorganisms at the point of entry into the catheter and subsequently in the bloodstream. MaxGuard is new technology introduced to assist hospitals in reducing catheter related bloodstream infections.

The introduction of MaxGuard comes at a time when bloodstream infection rates continue to be a major concern among hospitals. With the new federal policy restricting reimbursement for healthcare-associated infections (HAIs), healthcare professionals are seeking techniques and technologies to assist in their bloodstream infection prevention efforts.

With the addition of antimicrobial technology, MaxGuard is an enhancement of the MaxPlus Clear, Medegen’s leading positive displacement connector. It features Medegen’s patented positive displacement technology, which provides a bolus of fluid to clear the catheter tip upon disconnection from the device. It also features Medegen’s patented Tru-Swab® top which acts as a double seal barrier to contamination and allows for true disinfection during pre-access swabbing. The translucent housing provides for visualization of the fluid path allowing for complete flushing of the device.

“Healthcare professionals and facilities are seeking new technologies and practices to assist in their efforts to reduce the occurrence of catheter related bloodstream infections (CRBSI),” said Goble. “In addition to the negative impact on the patient, the cost of treating a single CRBSI can reach $56,000 or more according to the CDC and with changes in healthcare reimbursement practices, hospitals are looking for assistance in meeting infection reduction goals. We are very pleased to see the clinicians’ fast rate of adoption of the MaxPlus Clear and more importantly to receive feedback from many hospitals regarding bloodstream infection rate reductions concomitant with use of the MaxPlus Clear device.”

“We are excited to introduce MaxGuard and offer hospital clinicians yet another product to help prevent bloodstream infections, improve patient outcomes and reduce costs.”

MaxGuard Advanced Luer Activated Device will be available second quarter 2009.

About Medegen, Inc.

Medegen is a leading innovator in infusion therapy, focused on helping hospitals drive greater clinical performance for improved patient care. The growing company provides clinically superior medical products and reliable, cost-effective manufacturing services to the medical community through its three operating units: Manufacturing Services, Maximus and KippMed. Manufacturing Services provides cost-effective contract manufacturing solutions to medical device and pharmaceutical companies. KippMed manufactures and markets IV therapy components for the OEM market, drawing from a 25-year history in IV component supply. Maximus develops, manufactures and markets needleless intravenous therapy products for the acute care market. The Maximus line of medical products features patent-protected technologies which improve patient outcomes and greatly reduce bloodstream infection rates. Medegen is headquartered in Ontario, Calif. and has operations in Tijuana, Mexico. For more visit http://www.medegen.com/.