The Device Industry's Rx Marketing Dilemma
The big news out of this year's TCT meeting in September wasn't really news at all. The final results of the SIRIUS clinical trial, assessing restenosis rates and other clinical measures of the sirolimus-coated drug-eluting stent (now being marketed in Europe by Cordis Corp., a Johnson & Johnson operating company and soon to be available in the US) weren't all that different from the preliminary data previewed in May at the Paris Course on Revascularization.
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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.
Innovative device companies have always had to contend with the Sword of Damocles of unexpected technological obsolescence, but for would-be developers of interventional devices for the prevention of restenosis, the sword is dangling perilously close. In the RAVEL trial, a 238-patient clinical trial on a drug eluting stent, treated patients experienced 0% restenosis compared to 26% in the control group. Now, device developers with alternatives to stents reposition themselves to sustain businesses in the face of potentially shrinking target markets. Many argue that they will serve certain applications better than stents; others hope to work with drug-coated stents to enhance performance, many believe that economics will leave room for alternative approaches, and still others are getting out of the coronary business entirely.
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.