The Definitive Trial for atherectomy was intiated in April 2009 to evaluate the efficacy of the Silverhawk Atherectomy Device from EV3. The Silverhawk technology emerged on the scene to much fanfare with an aggressive marketing strategy in the early part of the decade. At that time, there was very little clinical data to support benefit of the device versus the available clincal alternatives POBA, Stent and surgical bypass.
Aggressive marketing toward groups like podiatrists endeared the technology and sealed its role in the treatment of PAD. Almost 10 years later, there is still little information available about the benefits of the technology outside of centers who tout excellent results with high volume useage. (
See Dr Mckinsey's comments by clicking here
Unfortunately, most patients are treated outside of high volume centers that have practitioners with well developed experiences and judgments about this technology. At this point, I believe that the 80/20 rule is in effect. The low volume guys hae virtually stopped using the technology and the high volume guys ie 20% of proceduralist are responsible for 80% of the volume and company revenue.
The question I raise is will the definitive trial answer questions and resolve the dilemma to establish a role for Silverhawk Atherectomy or will it leave Silverhawk technology and EV3 dead in the water. Im sure that competitors wait anxiously. ie Diamondback from CSI and Jetstream G2 from Pathway Medical. If the results are good, they will piggy back off the results obtaining borrowed credibility from the study of atherectomy. If the results are bad, they will run for cover claiming a different atherectomy technique
Better late than never
Posted by: moncler | December 21, 2011 at 05:33 PM