NIR paclitaxel stent study
This article was originally published in The Gray Sheet
Executive Summary
First three subjects in a 60-patient, randomized two-center Phase I trial are enrolled at the Siegburg Heart Center in Germany, Boston Scientific reports Oct. 12. The primary endpoint is major adverse cardiac events at 30 days. Patients also will be monitored at six months with intravascular ultrasound and angiography. An IDE filing in the U.S. is expected in the first quarter of 2001. The paclitaxel coating technology is licensed from Angiotech. The Vancouver-based company also licenses the technology to Cook Cardiology, which has a pivotal U.S. study of a paclitaxel stent under way. On Oct. 3, FDA approved Biocompatible's BiodivYsio phosphorylcholine-coated stent for marketing in the U.S. by Abbott (1"The Gray Sheet" Oct. 9, 2000, p. 15)