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Isotechnika Announces Enrollment Completion Of Its Partner Atrium’s CONFIRM 1 Trial For Voclosporin Coated Coronary Stent System

Isotechnika announced that its partner Atrium Medical Corporation has finished enrolling patients for the CONFIRM 1 trial for CINATRA voclosporin coated coronary stent system. CONFIRM 1 is the First-in-Man (FIM) drug coated coronary stent clinical trial. The CONFIRM 1 trial is a prospective, multi-center, single blind, randomized, controlled study evaluating the CINATRA voclosporin coated coronary stent system, which will be compared to Atrium's CINATRA bare metal coronary stent (BMS) platform. The study enrolled 100 patients and is currently being conducted at seven hospitals in Belgium with Principal Investigator Glenn Van Langenhove, MD, PhD of Middelheim Hospital, Antwerp. The primary endpoint of the trial is to evaluate the safety and performance of the CINATRA voclosporin coated coronary stent system in patients with de novo coronary artery disease. Patient outcomes, in addition to drug coated stent performance, will be assessed by measuring Late Lumen Loss, in-stent and in-segment lumen loss measurements at six months following implantation. "We are extremely pleased to have completed enrollment within our projected timelines," said Trevor Carlton, Atrium's President. "Our last patient is expected to have their six month follow-up procedure at the end of June 2009 with results available in the third quarter of this year."