www.hospitals-management.com News

American Medical Systems focusses on international markets

Fri, 30 Jan 2009 13:02:19 GMT

American Medical Systems, Inc. (AMS) has announced changes to its worldwide sales structure. AMS has organised its sales and marketing organisations into three regions around the world: North America, Europe Middle East Africa (EMEA), and Asia Pacific/Latin America.

“We are very pleased to announce this new structure to facilitate the worldwide expansion of AMS over the coming years,” said AMS President and CEO Anthony P. Bihl, III. “Mike and Francois each bring extensive experience in medical device sales and marketing outside the U.S. We are excited about the opportunity to expand the availability of our pelvic health solutions in the broader world market.”

K2M launches a simplified MIS technique for dynamic stabilization of the spine

Fri, 30 Jan 2009 13:02:19 GMT

K2M launches a simplified MIS technique for dynamic stabilization of the spine
K2M, Inc. has introduced an minimally invasive approach to dynamic fixation of the spine. The POTOMAC™ Rod System and the SERENGETI™ Minimally Invasive Retractor System have received CE Mark clearance for international distribution to expand its presence in within Europe and other countries. The POTOMAC Rod System, which will be distributed outside the United States, provides a simple and versatile one-piece rod design to enhance the stabilization characteristics of the spine.

“The introduction of SERENGETI and POTOMAC marks another important milestone in K2M’s mission to continually provide surgeons with techniques and technologies that will enhance their ability to treat spinal patients,” stated Eric Major, K2M’s President and CEO. “CE Mark clearance for these next generation products expands the K2M product offering and fuels our rapid growth into the global markets, helping to position K2M as a leader for developing solutions to help surgeons address the most complex spinal pathologies.”

Johnson & Johnson aompletes acquisition of Mentor

Fri, 30 Jan 2009 13:02:19 GMT

Johnson & Johnson has announced the completion of its announced acquisition of Mentor Corporation a supplier of medical products for the global aesthetic market. Mentor is expected to operate as a stand-alone business unit reporting through ETHICON, Inc., another Johnson & Johnson company.

According to Gary Pruden, Company Group Chairman, Johnson & Johnson, with responsibility for the ETHICON Franchise, "Mentor will become the cornerstone of a broader Johnson & Johnson strategy for aesthetic medicine -- serving both consumers and medical professionals. We will use our combined strengths and experience to build a market-leading aesthetic business that capitalizes on Johnson & Johnson's broad-based commercial capabilities, worldwide surgical care footprint, and clinical scientific capabilities."

TomoTherapy and Hitachi Medical Corporation enter into distribution agreement for Japan

Fri, 30 Jan 2009 13:02:19 GMT

TomoTherapy Incorporated announced that it has entered into an agreement with Hitachi Medical Corporation (HMC) to distribute the Hi•Art® cancer treatment system in Japan. Through the agreement, HMC will market, sell and service the innovative Hi•Art system, which facilitates highly precise, CT-guided radiation therapy for a wide range of clinical indications.

“Hitachi Medical Corporation is an ideal partner for us and for our valued customers, in one of our most important markets,” said TomoTherapy CEO Fred Robertson, M.D. “HMC’s robust national infrastructure and reputation for excellent technical and customer support will enhance our ability to service all hospitals in Japan that are currently using TomoTherapy technology. Additionally, this agreement represents a significant opportunity for us to reach new customers, and help advance the quality of cancer care across Japan, the second largest radiation therapy marketplace in the world.”

deCODEme Cardio(TM) and deCODEme Cancer(TM) launched

Fri, 30 Jan 2009 13:02:19 GMT

deCODE genetics announced that it has launched the first focused genetic scans for assessing personal risk of several major cardiovascular diseases and common cancers. deCODEme Cardio(TM) detects genetic risk factors for heart attack, stroke and atrial fibrillation, peripheral artery disease (PAD), and several other conditions. deCODEme Cardio(TM) measures 8 SNPs associated with the risk of heart attack, intracranical and abdominal aortic aneurysm, stroke and atrial fibrillation, peripheral arterial disease (PAD) and venous thromboempolism. deCODEme Cancer(TM) measures 29 SNPs associated with risk of prostate, lung, bladder and colorectal cancers, as well as basal cell carcinoma and the common form of breast cancer.

The scans deCODEme Cardio(TM) and deCODEme Cancer(TM) are based on assays custom designed by deCODE scientists to detect the single-letter genetic variations (called SNPs) with the biggest impact on disease risk.

Integra LifeSciences launches a series of PEEK-Optima(R) interbody spinal implants

Fri, 30 Jan 2009 13:02:19 GMT

Integra LifeSciences Holdings Corporation announced that it has launched a series of intervertebral body fusion devices (IBD), the Vu e-POD(TM) and Vu L-POD(TM) through the newly formed Integra Spine. The Vu e-POD and Vu L-POD received clearance from the United States Food and Drug Administration (FDA) to be marketed as a spinal IBD. Prior to receiving the IBD status, the devices were cleared by the FDA as spinal vertebral body replacement devices (VBR).

Randy Theken, President, Integra Spine, states, ``The Vu e-POD all-in-one insertion and distraction technique gives Integra Spine a true competitive advantage. It leads to benefits for both the surgeon and patient. No longer is a second instrument required to distract the disc space. It is accomplished through a simple rotation technique performed after inserting the device.''

Covidien receives FDA clearance for SILS(TM) Port Multiple Instrument Access Port

Fri, 30 Jan 2009 13:02:19 GMT

Covidien has announced that its Surgical Devices business unit has received 510(k) clearance from the U.S. Food and Drug Administration to market the Covidien SILS(TM) Port Multiple Instrument Access Port for laparoscopic surgeries through a single incision.

The SILS(TM) Port is a single, flexible port that can be fitted through a small incision in the umbilicus which results in a single "hidden scar," a cosmetic advance over the multiple visible scars associated with standard multi-port laparoscopy.

"SILS(TM) Port is the first device specifically indicated for multiple instrument access to the abdomen through a single incision," said Scott Flora, President, Surgical Devices, Covidien. "We led the first surgical revolution with multi-port laparoscopic surgery and Covidien is now leading the way again with SILS(TM) procedures and the new SILS(TM) Port, innovations that offer surgeons an immediate advancement in patient care," he added.

Laparoscopic procedures performed through a single incision are a significant evolution in the world of surgery. While laparoscopy traditionally offers better patient outcomes including less pain and improved cosmesis than the open approach, SILS(TM) procedures have the potential to dramatically extend these benefits. The SILS(TM) Port is scheduled for commercialisation in the United States and Europe later this year.

MEridian announces FDA approval

Fri, 30 Jan 2009 13:02:19 GMT

Meridian Co., Ltd., has announced that they have received FDA clearance to market the Lapex BCS (Body Contouring System) laser device.

According to the company press release "The FDA 510(k) Clearance has been granted based on our premarket notification for indications for the Use of 'elevating tissue temperature and temporary relief of muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or temporary relaxation of muscle'."

"The FDA Clearance allows us to market the Lapex BCS (Body Contouring System) which is a safe and pain free, non-invasive laser device, and is another important step in the ongoing marketing and development of Meridian's industry leading equipment," it added.

Sirona launches the CEREC® AC digital impression unit

Fri, 30 Jan 2009 13:02:19 GMT

Sirona has unveiled CEREC® AC. CEREC AC is built on Sirona’s proprietary CEREC Bluecam technology and its automatic image capture system operates so quickly and efficiently that entire quadrants can be scanned in just 40 seconds. CEREC AC sets new standards for speed of acquisition and ease of use. In addition, CEREC AC captures more detail, features easy-to-use intuitive software, and provides a uniform field of illumination for unparalleled precision.

Speaking on the same Jost Fischer, Chairman, President and CEO commented, “The CEREC AC represents a significant step forward for digital dentistry. Dentists can use the AC to easily and quickly create single-visit, high-quality ceramic restorations in their offices. Alternatively, using CEREC Connect, they can send their digital models to the laboratory, taking advantage of a wider range of material and treatment options.”

Stryker Endoscopy launches the world's first high-definition wireless surgical display with AMIMON's high-definition wireless technology

Fri, 30 Jan 2009 13:02:19 GMT

AMIMON Inc. announced that Stryker Endoscopy has launched the world's first high-definition (HD) wireless video display for the operating room. Stryker Endoscopy's WiSe(TM) HDTV is embedded with AMIMON's wireless HD technology. AMIMON has granted Stryker Endoscopy access to its technology for the medical endoscopy market.

"AMIMON's high-definition wireless technology is gaining strong industry support and is setting the standard for wireless HDTV connectivity," said Noam Geri, AMIMON's vice president of marketing and business development. "Several major CE manufacturers are currently offering a full range of products based on AMIMON's technology. AMIMON is proud to have worked with Stryker Endoscopy in enabling the use of its technology to meet the demanding needs of medical visualization."