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AdvaMed commends China's measures to streamline regulatory process
China's health ministry and the State Food and Drug Administration will retain responsibilities regarding recalls of medical devices in an effort to prevent redundancies in recall regulations. The move is one of the measures for streamlining the regulatory process for devices announced by the Chinese government at a meeting of the U.S.-China Joint Commission on Commerce and Trade in Hangzhou, China. Clinica (subscription required) (11/2)

Business & Market Trends

FDA says Zimmer's spinal implant meets study goal
FDA reviewers said Zimmer Holdings' Dynesys implant is as effective as the company's Silhouette implant in treating spinal problems, but raised questions about possible influence on the study. A company spokesman did not immediately comment on the issue. An FDA panel is set to meet Wednesday to discuss the product. Google/The Associated Press (11/2)

Hospitals raise concerns over confidentiality of device prices
Some hospitals find it hard to negotiate prices for medical technologies because device firms sometimes require confidentiality requirements that prevent hospitals from disclosing the prices of products to companies that sell data to help analyze market conditions. The device sector recognizes its confidentiality practices, saying price disclosure could result in higher prices and might lead to collusion. "The evidence is strong that the competitive forces in our industry work extremely well," AdvaMed Senior Executive Vice President David Nexon said. The Wall Street Journal/Dow Jones Newswires (11/2)

Wright Medical buys Tennessee facility
Wright Medical Group spent $1.5 million to buy a 56,340-square-foot facility in Arlington, Tenn., that will focus on the distribution of its orthopedic devices. American City Business Journals/Memphis, Tenn. (11/2)

Doctor cites hospital execs' financial ties with device firm in lawsuit
David Gossman, an interventional cardiologist formerly with Lahey Clinic hospitals in Boston, has filed a lawsuit claiming that he was dismissed after complaining about the financial ties of hospital executives with Medtronic. Gossman also claims that the officials pushed other physicians to use more products from the company. A spokesman for Medtronic said he wasn't able to verify the link between the firm and hospital officials and noted that the company's code of conduct would not permit such a behavior by the executives. The Wall Street Journal/Health Blog (11/2)

International Developments

Kinetic Concepts gets Japanese approval for wound-care system
Kinetic Concepts has received final marketing approval from Japan's Ministry of Health, Labor and Welfare for its V.A.C. Therapy System designed to treat difficult-to-heal wounds. The company expects the Japanese government to grant reimbursement approval for the product during the first half of next year. American City Business Journals/San Antonio (11/2)

EU approves Boston Scientific stent Promus Element
Boston Scientific secured European approval for its Promus Element drug-coated stent, which is made of an alloy that offers more flexibility than older stents. The company expects the FDA to approve the device by 2012. The Boston Globe/The Associated Press (11/2)

Emerging Technologies

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Medtronic heart valve benefits pediatric heart patient with H1N1
Physicians at Children's Hospital Boston were able to alleviate complications caused by H1N1 flu virus in a 4-year-old boy with a congenital heart defect after implanting Medtronic's Melody heart valve. The experimental valve can be implanted with the help of a catheter without requiring patients to undergo open-heart surgery. The Wall Street Journal (11/2)

St. Louis patient gets first total artificial heart
A team of surgeons at Barnes-Jewish Hospital successfully implanted the CardioWest temporary Total Artificial Heart in a 47-year-old male patient in St. Louis. The FDA-approved device is an updated version of the Jarvik-7 Artificial Heart. American City Business Journals/St. Louis (11/2)

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Government & Regulatory

House GOPs criticize "federal bureaucracies" in health proposal
Republicans in the House of Representatives warned that the Democrats' health reform proposal would create 111 new federal bureaucracies, programs and boards, citing a health insurance exchange, an FDA women's health unit and a CMS center for innovation, among others. A Democratic source said the "bureaucracies" are only new "programs and demonstration projects" that would be used to "test new policies before more broadly implementing them." FoxNews.com (11/2)

AdvaMed News

Advertising and Promotion of Medical Devices
What are the regulatory and legal guidelines for appropriate advertising and promotion of medical technologies? How and when are companies permitted to disseminate off-label information or to respond to physician requests? Legal experts, company compliance officers and representatives from the FDA offer guidance in these and other areas. More information. Medical Technology Learning Institute -- Education Beyond a Degree

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