Medical Device Link.

Medtech IPOs: The Comeback Continues

Following a complete absence from the initial public offering (IPO) market in 2003, the medtech sector made a strong comeback in 2004, with 18 companies going public. Showing considerable sector momentum during the period, the number of companies issuing IPOs in the second half of 2004 was double that of the first six months. [ more ]

Cyberonics Gets FDA Reversal

Cyberonics CEO Cummins: All’s well that ends well?

At odds with FDA concerning its alleged noncompliance with good manufacturing practices (GMPs), and denied approval of its Vagus Nerve Stimulation (VNS) Therapy System for the treatment of severe depression, Cyberonics (Houston) was going through some rough times with the regulatory agency.

Yet, in a decision that came earlier than many industry analysts had expected, FDA recently reversed its previous action and approved the VNS device for the treatment of depression.

In an all’s-well-that-ends-well world, that might be the end of the story. But wait. There’s more.

The Cyberonics story offers real-world lessons about the current status of harmonized industry standards and the international product approval process for medtech manufacturers. While the medical device industry has long sought a harmonized regulatory framework that would permit plant inspections and product approvals carried out by one agency to be recognized by others throughout the world, the experience of Cyberonics suggests there is still a long way to go before that goal is achieved. [ more ]

Medtronic Unit Licenses Paralysis-Prevention Technology from Purdue

Purdue’s Borgens: A molecular Band-Aid.

Could preventing permanent spinal cord damage be as simple as injecting a patient with a specialized inorganic liquid polymer shortly following trauma? In a recently published study with dogs, researchers at the Purdue University Research Foundation (West Lafayette, IN) successfully demonstrated that an injection of polyethylene glycol (PEG) can prevent permanent spinal damage when administered within 72 hours of the injury. [ more ]

Medicare Expands Coverage of Cardiac Defibrillators

The Centers for Medicare and Medicaid Services (CMS; Baltimore) has announced a significant expansion of its reimbursement coverage for implantable cardioverter-defibrillators (ICDs).

CMS’s Tunis: A careful review.

Under the new guidelines, Medicare recipients with mild-to-moderate heart disease may now be eligible to receive the stopwatch-sized implants that regulate cardiac rhythm to ensure that the heart is pumping blood adequately. Before the new ruling, coverage was limited mostly to patients with more severe heart disease, including those that had previously suffered sudden cardiac arrest (SCA).

The decision to expand coverage was based primarily on the findings of a long-term study of more than 2500 patients sponsored by National Institutes of Health (NIH; Bethesda, MD) which found that ICDs reduced deaths by 23% in heart disease patients including those that had not experienced SCA. The findings of the study, “Sudden Cardiac Death in Heart Failure” (SCD-HeFT), were initially reported in March 2004, at the annual scientific session of the American College of Cardiology (ACC; Bethesda, MD). [ more ]

Auto Supplier Sets Its Sights on Medtech Market

Battenberg: From cars to cardiology.

“During these challenging times for the automotive industry, we’ve remained focused on the actions needed to advance our transformation—and 2004 showed significant progress,” said J. T. Battenberg III, chairman and CEO of Delphi Corp. (Troy, MI), the world’s largest supplier to the automotive industry, in a recent address to investors and analysts.

And Delphi Medical Systems, a wholly owned subsidiary of the parent company, is a major part of that transformation.

According to Christophe Sevrain, managing director of Delphi Medical Systems, a key goal of the company’s diversification strategy is to become “the leading provider of products, technologies, and manufacturing services to the medical device industry.” [ more ]

Silicone Breast Implant Manufacturers to Get FDA Hearing

Inamed CEO Teti: Continuing the dialogue.

The on-again, off-again saga of silicone breast implants is slated to get another hearing this April, and manufacturers of the products are hopeful that this time they’ll pass muster with FDA.

Inamed Corp. and Mentor Corp. (both in Santa Barbara, CA), two leading manufacturers of silicone gel breast implants, will have their updated premarket approval (PMA) applications reviewed by FDA’s general and plastic surgery advisory panel in a meeting scheduled for April 11–13.
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Philly Center Boosts Start-Up Funding

Science Center’s Banerjee: A systematic approach.

The University City Science Center (Philadelphia), an incubator and mentor of local high-tech startups, has announced a plan to cultivate 40 new Philadelphia-based life science and technology companies, with a combined market value of $1 billion, in the next five years.

The Science Center is looking to help medical device, diagnostic, and software companies benefit from the approximately $1 billion in NIH research grants and more than $3 billion in corporate research and development that flow through the area annually. Approximately 70% of the Center’s funding, though, will go to companies working in the life sciences. [ more ]

The editors welcome your suggestions for future content in MX: Issues Update. Please feel free to contact us with your comments and ideas. —Steve Halasey, Editor in Chief, MX