Kensey Nash Distal Protection Redesign Responds To GuardWire Success
This article was originally published in The Gray Sheet
Executive Summary
Kensey Nash's redesign of its development-stage Aegis Vortex system follows initial clinical experience indicating the device would likely be more difficult to operate than Medtronic/PercuSurge's GuardWire distal protection device.
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Kensey Nash
Clinical trials for the TriActiv balloon protected flush extraction system commence in Europe and U.S., firm announces May 24. First U.S. patient receives the device May 30; the European trial began the previous week. U.S. trial is expected to involve up to 50 sites and 800 patients with enrollment slated for completion in late 2002, when the firm plans to submit a 510(k). A primary clinical endpoint is reduction in major adverse cardiac events. The TriActiv, a redesigned version of the Aegis Vortex, is engineered to protect against distal embolization and to extract occlusive debris during stent treatment of occluded saphenous vein grafts (1"The Gray Sheet" March 5, 2001, p. 14)
Kensey Nash
Clinical trials for the TriActiv balloon protected flush extraction system commence in Europe and U.S., firm announces May 24. First U.S. patient receives the device May 30; the European trial began the previous week. U.S. trial is expected to involve up to 50 sites and 800 patients with enrollment slated for completion in late 2002, when the firm plans to submit a 510(k). A primary clinical endpoint is reduction in major adverse cardiac events. The TriActiv, a redesigned version of the Aegis Vortex, is engineered to protect against distal embolization and to extract occlusive debris during stent treatment of occluded saphenous vein grafts (1"The Gray Sheet" March 5, 2001, p. 14)
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