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.
You may also be interested in...
In a career that has spanned more than 20 years, Bill Hawkins has worked for a wide array of medical device firms, leaving his imprint on this industry. Now, as Medtronic's COO, his influence will only grow. In this interview, Hawkins talks about the history of the device industry and what lies ahead.
Endologix needed cash, Radiance Medical needed a new market. Each found what it needed in a merger which will give Endologix the resources to develop its AAA graft line while helping Radiance segue out of a coronary brachytherapy market all but decimated by drug-eluting stents.
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.