Having built up a $500 million business with the only approved coronary stent on the US market, Johnson & Johnson's Cordis watched virtually all of it slip away to competitors who came to market with superior products. But now the company is back, with the introduction of a new line of stents, expansion into a broad line of cardio- and vascular products, and a head start in one of the most promising device areas: drug-coated stents. Cordis' goal: to be number one again.
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The story of the successful development by Cordis Corp., a Johnson & Johnson operating company, of the first drug-eluting stent, the Cypher, and its introduction this year into the US market has been well chronicled. What is not as well known is the equally successful and ground-breaking work that Cordis did in obtaining incremental reimbursement (an increase over the existing reimbursement level for bare metal coronary stents) for the Cypher stent from Medicare prior to the device receiving FDA approval. This is an interview with the person who directed Cordis' reimbursement efforts for the Cypher stent, Brian Firth, MD, PhD, VP for medical affairs and health economics, who explains how Cordis developed and implemented its reimbursement strategy for Cypher, and the implications of this approach for future new technologies.
For many device companies and their investors, drug-eluting stents have come to represent a kind of technological end-game, a device so successful at solving an important unmet need that all future opportunities lie elsewhere. But, in fact, there are still many important unsolved problems in interventional cardiology, not the least of which is chronic total occlusions, lesions so thick and dense that blood can't flow through the artery. That's the problem LuMend has set out to solve and it has the first US-approved device on the market. And while some question the company's timing, LuMend officials argue they couldn't be better timed, since their device and drug-eluting stents go hand in hand.
At this year's Paris Course on Revascularization, much of the discussion turned to drug-eluting stents. An important new clinical trial underscored the technology's value in reducing or eliminating restenosis. But with the product now commercially available in Europe, economic concerns are beginning to be heard loudly.