Medical Device Link.

When FDA approved the first carotid stent, in August 2004, many industry analysts suggested that the market for such devices could reach $1 billion by 2010. Since that time, however, forecasts have been adjusted downward as U.S. carotid stent manufacturers continue to face a number of hurdles on the approval, reimbursement, and professional practice fronts.

The Centers for Medicare and Medicaid Services (CMS; Baltimore) last reviewed carotid stenting in March 2005. But the expanded Medicare coverage offered by the agency at that time fell far short of what many interventional cardiologists and industry analysts had expected.

More-robust clinical data and comparative studies are expected to provide a boost for market acceptance of carotid stenting over the next several years. Nevertheless, there remains a great deal of resistance to the procedure among vascular surgeons, who cite the established history and success rate of traditional endartarectomy. [ More ]

The battle began last month, when Guidant, now a business unit of Boston Scientific Corp. (Natick, MA), sought to prevent the medical products testing organization ECRI (Plymouth Meeting, PA) from publishing the prices paid by hospitals for the company's cardiac rhythm management devices. In turn, ECRI filed a lawsuit with a federal district court in Pennsylvania, alleging that Guidant's action would violate ECRI's first-amendment rights. Guidant countersued with a court filing in Minnesota.

"No matter where you sit on the political spectrum, you know that the ability to compare products—whether it is cars or lifesaving technologies—is fundamental to an efficient marketplace," said ECRI president and CEO Jeffrey C. Lerner, PhD. "Simply put, ECRI believes that patients, along with their implanting physicians, have the right to know the cost of the pacemakers that are implanted in their chests."

The legal proceedings are in the very early stages with no hint of a settlement and no court date set as of yet. [ More ]

Commenting on the initiative, Andrew C. von Eschenbach, MD, acting FDA commissioner, said, "We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available. By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices."

In implementing the initiative, FDA's Center for Devices and Radiological Health will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least-burdensome approach to clinical trials. The agency says the initiative builds on the device review program provided under the Medical Device User Fee and Modernization Act of 2002. [ More ]

Boston Scientific's decision was very much in evidence at the recent Boston meeting of the Heart Rhythm Society(HRS; Washington, DC) where more than 6000 cardiac specialists saw Boston Scientific banners displayed throughout the convention hall. Although the banners included a small Guidant logo, even that acknowledgment is expected to be phased out before year's end.

Boston Scientific CEO James Tobin, who was a highly visible presence at the company's HRS booth, spoke openly about the need to move forward. He said that unified branding was just one step in the integration of the two companies, but an important one. He focused on the theme of the company's "We can and we will" campaign, which seeks to emphasize its core strengths for both recovery and continued growth.

Boston Scientific, with a combined workforce of 27,000 and projected annual sales of $10.2 billion, has now eclipsed Medtronic Inc. (Minneapolis) as the world's largest manufacturer of cardiovascular devices. [ More ]

A recent decision in the U.S. District Court in Delaware went in favor of Boston Scientific Corp. (Natick, MA) over rival Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company—but neither company expects this ruling to be the final word. Instead, the most recent ruling evened the count at two litigation victories apiece for the two companies, which are involved in a long-term battle related to patent infringement in the design of coronary stents. Cordis has already indicated that it intends to appeal the most recent ruling.

The U.S. District Court for Rhode Island offered a more definitive resolution to a 10-year series of patent infringement battles between Davol Inc. (Cranston, RI), a subsidiary of C. R. Bard Inc., and Stryker Corp. (Kalamazoo, MI). The court granted a summary judgment in favor of Stryker, freeing it of infringement claims against its Interpulse medical irrigation device.

In this issue, MX: Issues Update reviews other recent cases of interest to medtech executives. [ More ]

"Women today have an array of medical options for female-specific conditions that they didn't have 20 years ago," says Sherry Marts, PhD, vice president of scientific affairs for the Society for Women's Health Research. "It's exciting that we are now starting to see gender-specific devices for conditions that are common in both men and women." [ More ]

"Minnesota remains a leader in certain biobusiness subsectors," says Dale Wahlstrom, chairman of the BioBusiness Alliance of Minnesota. "The 1997–2002 trends identified in the studies must not only be turned around, but growth must be accelerated in order for Minnesota to remain competitive." [ More ]

"This campaign is the first of its kind in the medical device industry," says Michael J. McGarry, executive vice president for public affairs at AdvaMed. "There is a broad recognition among our member companies that there is an opportunity for us as an industry to get out there and define ourselves rather than allowing others to define us." [ More ]

The first-place prize of $10,000 was awarded to a team from the University of California, Berkeley, that created a tissue-engineering approach to construct vascular grafts from bone-marrow stem cells to be used in coronary artery bypass graft procedures. Other winning inventions included an alternative method of breast-cancer detection; a low-cost, light-reflecting device for the detection of anemia; and a telerobotic biopsy system designed to facilitate earlier, more-accurate diagnoses of cancerous lesions. [ More ]