Profits roll in as J&J remains unchallenged in U.S. stent market. (Johnson and Johnson)

There is virtual across-the-board unanimity among physicians that stents - those tiny mesh-like devices that act as a scaffold to prop open a clogged artery - do their job and do it well. Stents have been available on the U.S. market only for about two years and have quickly grown into the trendiest of all cardiac products. But now, stent use is being called into question not for clinical reasons, but because of some thorny reimbursement issues. In short, payments to hospitals for surgically treating most coronary patients have fallen considerably short of the up-front costs involved in a stenting procedure.

Efficacy aside, however, the stent rage appears to be a symptom of a financial problem that plagues U.S. health care today. In fact, the same may be true for nearly every new device that hits the U.S. market without an appropriate DRG and a reimbursement to match. Low reimbursements can have the effect of rendering a proven, quality product that creates strong patient outcomes a money-pit for providers, and put a drag on device sales that could last years.

Estimates are that somewhere between 132,000 and 170,000 stents (in approximately 400,000 total cases) will be inserted into American patients this year, for an average of about 1.3 stents per patient, according to a study presented in New Orleans at the American Heart Assn. annual meeting by Dr. Eric Peterson of Duke University Medical Center. Fully one-quarter of stented patients have two or more stent insertions. However, pointing to those numbers, he warned cardiologists that stents "may become a luxury that hospitals cannot afford."

Just two U.S. manufacturers produce all stents currently used in this country. As many as 95% are sold by Cordis Corp., Warren, N.J., a company that was acquired early this year by Johnson & Johnson, New Brunswick, N.J. The others are sold by Cook Inc., Bloomington, Ind., a company that is facing a patent suit filed by J&J in a dispute centering around stents. The stakes in the case couldn't be much higher. Estimates are that the annual U.S. stent market stands as high as $600 million ($1.2 billion worldwide). After several delays, the case is …