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Dimming Brachytherapy's Glow?

Executive Summary

Disappointing clinical trial results have investors fleeing coronary-radiation leader Novoste, but is there more to the story?

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Hijacking the Restenosis Market

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.

Novoste: Radiation's Glowing Promise

At this year's American College of Cardiology meeting, radiation pioneer Novoste squeezed in at the last minute with data from its START clinical trial proving the safety and efficacy of radiation in treating in-stent restenosis. Novoste's path to this promising opportunity has been long and costly and fraught with regulatory challenges, epitomized by a European launch that, company officials say, was misunderstood by most industry observers. To be sure, radiation still has its skeptics and critics, but Novoste and its supporters believe that the START data underscores that beta radiation represents the best hope for future restenosis treatments. The real significance of the START data isn't that it proves that radiation works--it's that, for now, the future debate about radiation is likely to be defined by Novoste.

December ANDA Rush Is Largest In Two Years

December's ANDA rush has provided the largest monthly haul in two years. However, the month may be losing its influence over the US FDA's annual submission total.

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