A Better Mouse Trap
By their very nature, successful new technological approaches to large, unmet clinical needs--the Holy Grail for companies and their investors--have to offer something new, something that the existing gold standard didn't. But it is precisely that innovative approach that gives physician pause. New technology is often too slowly adopted. If drug-eluting stents catch on in great numbers,, they may revive the debates about the value of technology.
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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.
The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.
Medtronic is sponsoring a trial to evaluate its adaptive deep brain stimulation technology, a unique feature of the Percept PC device for treating Parkinson’s disease.