Medical Device Link.

FDA Panel Provides Cautious Support for
Drug-Eluting Stents

Gunderson

When FDA's circulatory system devices advisory panel met earlier this month to review drug-eluting coronary stents, many industry analysts raised concern that use of the devices could be sharply curtailed given the firestorm of safety issues that had been raised prior to the meeting. Yet, after two days of data review and analysis, the panel adopted a more moderate stance than generally anticipated. Although acknowledging that previous clinical studies of drug-eluting stents indicated a greater incidence of late-term thrombosis than with bare-metal stents, the panel concluded that the magnitude of the greater incidence is uncertain and additional data are needed. Drug-eluting stents were not found to increase the risk of death or myocardial infarction compared to bare-metal stents despite the apparent increase in stent thrombosis.

Thomas Gunderson, managing director and senior research medtech analyst with Piper Jaffray & Co. (Minneapolis), says the panel’s preliminary findings are generally favorable to both manufacturers with devices already on the market and those that hope to gain entry in the future. “The panel is apparently not recommending any changes in procedures or requirements in clinical studies as part of the FDA approval process,” he says. “The emphasis here is on postmarket surveillance and follow-up.” [ More ]

Democratic Congress May Mean Increased Device Scrutiny

Waxman

The upcoming flip in congressional control could have significant implications for the medtech industry. When the 110th Congress convenes in January, Representative John Dingell (D–MI) will lead the House Committee on Energy and Commerce, and Representative Henry Waxman (D–CA) will assume chairmanship of the House Committee on Government Reform. Meanwhile, on the other side of Congress, Edward M. Kennedy (D–MA) will lead the Senate Committee on Health, Education, Labor, and Pensions. Industry observers expect postmarket surveillance of devices to rank high on the healthcare agendas of these and other Democratic leaders. [ More ]

FDA Approves Silicone Breast Implants—with Conditions

Guy

After a 14-year hiatus, silicone breast implants are back on the market following last month’s approval by FDA. The devices were banned in 1992 due to concerns about leakage and the potential for causing bodily harm and disease. The agency’s approval follows years of opposing scientific claims—and hundreds of lawsuits—regarding the safety of the implants. Due to the lifting of the ban, industry analysts expect the market for breast implants to double over the next few years.

Mentor Corp. (Santa Barbara, CA) and Allergan Inc. (Irvine, CA) are the primary manufacturers of silicone breast implants in the United States. FDA approval came with a number of conditions for both companies, including extensive follow-up studies to determine the long-term safety and efficacy of the devices, better physician training, more-detailed product labeling, continued analysis of device failure, and the development of a tracking system to notify patients and surgeons of any potential problems.

“Silicone breast implants have been scrutinized more than any medical device, and we applaud FDA for making its well-thought-out decision and allowing American women to make informed choices about their healthcare,” said Roxanne Guy, MD, president of the American Society of Plastic Surgeons (Arlington Heights, IL). [ More ]

Medtech Industry Responds to Forbes Article

Perlotto

“Dangerous Devices,” the cover story of the November 27 issue of Forbes magazine, has attracted widespread criticism from members of the medical device community. In the article, the authors focus on recent high-profile device recalls and safety concerns. They also call into question the medtech industry’s “overly lax regulatory process, trials that are far less demanding than those for drugs, and a lack of follow-up after treatment.”

"By focusing on inflammatory rhetoric and calling out only instances of bad outcomes or situations, the public media has found it can manipulate public opinion with only half the story,” says Mark S. Perlotto, executive vice president and chief marketing officer of Adair-Greene Healthcare Communications (Atlanta). “The Forbes article has the potential to turn the sentiment toward the companies mentioned and the industry as a whole to the negative perception. Medical device companies have to do a better job of continuously communicating the positive contributions they make to the advancement of health and medicine to counteract these negative attacks by the media.” [ More ]

OIVD Releases 2005 Annual Report

Gutman

FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has made significant strides in integrating the critical IVD regulatory functions of premarket review, compliance oversight, and postmarket surveillance into a single cohesive unit, says the office’s director, Steven Gutman, MD. Formerly part of the Office of Device Evaluation, OIVD was launched three years ago as a separate entity within the agency’s Center for Devices and Radiological Health (Rockville, MD).

Released earlier this month, OIVD’s 2005 annual report notes that the IVD sector is poised for significant growth as the era of molecular diagnostics and personalized medicine continues to steadily advance. “OIVD is up for the challenge of becoming an engaged and proactive member of this diagnostic revolution,” Gutman said. “It is our hope that our role at the table will be one of facilitator and partner rather than obstacle. We are committed to the important mission of promoting and maintaining availability of safe and effective diagnostics for use in the medical marketplace.” [ More ]

Medicare Panel Seeks Further Study on Spinal Fusion

McCormick

When the Centers for Medicare and Medicaid Services (CMS; Baltimore) announced a meeting to examine the clinical merits of spinal fusion, many industry analysts speculated that the agency was reconsidering its coverage of the surgical procedure. Their concern was piqued by the advance release of a technology assessment concluding that no clinical evidence exists to demonstrate short- or long-term benefits of lumbar spinal fusion when compared with nonsurgical treatment. Despite assurances from Steve Phurrough, MD, director of the CMS coverage and analysis group, that the purpose of the meeting was to review clinical evidence regarding the efficacy of the procedure—and not coverage—some analysts were not assuaged and alerted their clients that the outcome of the meeting could adversely affect the spine industry.

John McCormick, managing director of HealthPoint Capital ( New York City), a private equity firm focused on the orthopedics sector, describes the meeting of the Medicare Coverage Advisory Committee (MCAC) as confused and inconclusive. “Panel participants generally agreed that fusion in the absolute sense is beneficial in terms of reducing pain and disability, but noted that the superiority of the procedure compared to nonoperative care cannot be demonstrated on the basis of current evidence,” says McCormick. “MCAC is calling for better clinical studies—and asking how those studies can best be designed to provide the necessary data for a clear-cut, objective assessment of spinal fusion.” [ More ]

2007 MDEA Final Deadline Approaching