HUDSON, N.H., June 9 /PRNewswire/ -- Atrium Medical announced today that it has begun enrollment of the first patients for their CONFIRM 1, First-in-Man (FIM) drug eluting coronary stent clinical trial. Atrium's European FIM clinical trial study is evaluating Atrium's CINATRA(TM) voclosporin coated coronary stent system.
This First-in-Man trial is a prospective, multi-center, single blind, randomized, controlled study using the CINATRA(TM) voclosporin coated coronary stent system, which will be compared to Atrium's CINATRA(TM) 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(TM) voclosporin coated coronary stent system and the CINATRA(TM) 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 very excited to be able to study the new CINATRA(TM) coronary stent platform with voclosporin, a promising new drug, and the company's all natural O3FA coating technology that merges the desirable 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.
About the CINATRA(TM) Voclosporin Drug Eluting Coronary Stent System
The CINATRA(TM) voclosporin coated coronary stent system is an advanced cobalt chromium balloon expandable stent, mounted on a low profile rapid exchange catheter. Atrium's stent and balloon are both coated with Atrium's proprietary Omega 3 fatty acid coating technology, providing a more uniform bio-absorbable delivery vehicle for its anti-inflammatory compound, voclosporin.
Voclosporin is a next generation calcineurin inhibitor and was selected for its desired anti-inflammatory properties in the vascular system. Voclosporin is a product of Edmonton-based Isotechnika Inc., licensed exclusively to Atrium Medical in 2005 for use with implantable medical devices.
Atrium's vast expertise in medical device technologies for the treatment of cardiovascular disease, hernia and adhesion prevention has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and soft tissue repair. Maintaining a commitment to the latest ISO13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in those healthcare segments that require more advanced surgical intervention for improvements in patient outcome. For more information, call 800-370-7899 or visit http://www.atriummed.com.
|SOURCE Atrium Medical|
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