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Angiotech: FDA labels Vascular Wrap paclitaxel-eluting graft a 'device,' paving way for faster approval
By E. Janene Geiss
Philadelphia, Dec. 20 - Angiotech Pharmaceuticals, Inc. announced Tuesday that its Vascular Wrap Paclitaxel-Eluting Mesh/Lifespan Vascular Graft has received a designation of "device" from the Office of Combination Products at the Food and Drug Administration.
This designation has historically indicated a faster regulatory and commercial timeline for a product as compared to when the FDA considers a combination product to be a "drug," according to a company news release.
Angiotech said it plans to initiate the Prevail (Paclitaxel Releasing Extra-Vascular Anastomosis Implant & Lifespan Graft) clinical trial in the first half of 2006.
Prevail will be designed to assess the efficacy and safety of Angiotech's pioneering Vascular Wrap Paclitaxel-Eluting Mesh/Lifespan Vascular Graft combination product in patients with end-stage renal disease who are undergoing hemodialysis, officials said.
As a combination product, the graft serves as an access port for hemodialysis and the intent of the drug-eluting mesh is to prevent the scar formation that often leads to graft failure.
Currently, about 50% of these grafts require replacement or revision within one year as a result of scar formation, officials said. The cost of these graft failures is significant, officials said, estimated at an additional $55,000 per failure.
"We consider this decision by the Office of Combination Products as an incremental, positive step forward for our Vascular Wrap paclitaxel-eluting mesh program," Rui Avelar, chief medical officer at Angiotech, said in the release.
Vancouver-based Angiotech is a specialty pharmaceutical company focused on combining pharmaceutical compounds with medical devices and biomaterials to both create novel solutions for poorly addressed disease states and improve surgical outcomes.
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