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News

Atrium starts Cinatra voclosporin coated coronary stent clinical trial

Atrium Medical : 10 June, 2008  (Company News)
Atrium Medical has begun enrollment of the first patients for its CONFIRM 1, First-in-Man (FIM) drug eluting coronary stent clinical trial.
Atrium's European FIM clinical trial study is evaluating Atrium's Cinatra voclosporin coated coronary Stent system.

This First-in-Man trial is a prospective, multi-centre, single blind, randomised, controlled study using the Cinatra voclosporin coated coronary Stent system, which will be compared to Atrium's Cinatra bare metal coronary Stent (BMS) platform.

This first use study of voclosporin on an implantable medical device will enroll 100 patients, and will be conducted at seven hospitals in Belgium with Glenn Van Langenhove, MD, PhD of Middelheim Hospital, Antwerp, as the study's principal investigator.

The primary endpoint of the trial is to evaluate the safety and performance of the Cinatra) voclosporin coated coronary Stent system and the Cinatra BMS 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.

After many years of pre-clinical testing, Atrium is able to study the new Cinatra coronary Stent platform with voclosporin, a new drug, and the company's natural O3FA coating technology that merges the safety benefits of a bare metal Stent with the clinical advantages of a bio-absorbable Omega 3 fatty acid coating.

Use of Atrium's patented Omega 3 coating platform, together with its novel drug compound has created a new class of patient treatment options who require a drug eluting coronary stent. Interventional cardiologists and patients alike have been waiting for a new technology that delivers the effectiveness of a drug eluting Stent with a safer, more natural, non-polymer coating platform resulting in a well healed Implant shortly after insertion.
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