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.

Two years ago, OmniSonics, a small medical device firm with a promising application in BPH, ran into a brick wall in discussions with investors; some of that was due to dot-com mania, but investors also evinced distaste for the urology and gynecology markets. A poor industry track record, compounded by reimbursement troubles, cautious physician adopters, and patients sometimes reluctant to seek treatment, had left earlier investors in the space feeling burned. But there's reason to hope that investor skittishness will begin to fade. Not only is the market driven by strong demographics, but also social and cultural taboos are coming down. For all its problems, for many device companies, particularly for large ones, the opportunity in urology and gynecology may soon become too attractive to turn down.

Ekos Corp. may have found a fast, but kinder and gentler way to lyse obstructive blood clots, with a patented catheter that can simultaneously deliver ultrasound waves and a thrombolytic drug directly to the site of a clot.