Navigation Links
Atrium Medical Corporation Announces First Implant of First-in-Man CINATRA(TM) Voclosporin Coated Coronary Stent
Date:6/8/2008

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.

About 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.

About Atrium

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
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. OxyBand Technologies, Inc. Hires a Leader in Medical Technology as Chief Technology Officer
2. Valor Medical Reports Early Clinical Results of New Technology to Treat Cerebral Aneurysms
3. Prescient Medical, Inc. Achieves Successful Clinical Debut of vProtect(TM) Luminal Shield
4. Sahajanand Medical Technologies PAINT Trial Results Support Safety and Efficacy of the Infinnium and Supralimus Stents
5. Join NPRs David Ewing Duncan, Author Jessica Queller and a Panel of Medical and Legal Experts in a 90-Minute Webcast on Genetic Testing, Genomic Medicine and Breast & Ovarian Cancer
6. Top Academic Medical Centers, Research Institutions, and Partners Gather, Share Experiences and Success Stories at Velos eResearch Annual Meeting
7. Globus Medical Completes Enrollment Of SECURE(R)-C Cervical Artificial Disc Clinical Trial
8. New Data Show High Frequency of Medical Claims for Gastrointestinal Events by Patients on Antiplatelet Therapy
9. Quantum Immunologics, Inc. and the South Alabama Medical Science Foundation Announce an Early Clinical Evaluation of a Novel Immuno-therapeutic Vaccine for Treating Advanced Human Breast Carcinomas
10. Delcath Expands Phase III Trial for Metastatic Melanoma to Include University of Maryland Medical Center
11. Tepha Announces First Human Usage of Medical Devices Derived from New Class of Resorbable Polymers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... April 20, 2017  CVS Pharmacy, the retail ... a new store design to enhance the retail ... food, health-focused products and expanded beauty selections paired ... customers discover new offerings. Together with its innovative ... of the customer experience at CVS Pharmacy.  ...
(Date:4/20/2017)... , April 20, 2017 NeuroVive Pharmaceutical ... today announced positive preclinical results demonstrating anti-fibrotic ... for non-alcoholic steatohepatitis (NASH), in an additional ... NV556 has previously shown similar anti-fibrotic ... Today, NeuroVive,s scientists present novel data demonstrating ...
(Date:4/19/2017)... 19, 2017  IRIDEX Corporation (Nasdaq: IRIX ... for the first quarter 2017 after the close of ... team will host a corresponding conference call beginning at ... Investors interested in listening to the conference call may ... or (703) 326-3030 for international callers, using conference ID: ...
Breaking Medicine Technology:
(Date:4/26/2017)... (PRWEB) , ... April 26, 2017 , ... Miami native ... as a dentist. , “I could have never imagined back in 1991 that this ... said Dr. Gallardo. , Over the last 25 years, Dr. Gallardo has pioneered implant ...
(Date:4/26/2017)... Pa. (PRWEB) , ... April ... ... division, which provides an agile ecosystem and domain expertise for sponsors and ... configurable randomization and trial supply management (RTSM) software platform. Bioclinica AGILE ...
(Date:4/25/2017)... ... April 25, 2017 , ... ProRehab Physical Therapy (PRPT) ... preferred physical therapy provider for Derby City CrossFit, effective immediately. , In addition ... quickly and effectively as possible, ProRehab’s sports physical therapists will work with athletes ...
(Date:4/25/2017)... (PRWEB) , ... April 25, 2017 , ... ... Liberty attempts to compare student test score performance for the 2015-16 school year ... the state’s voucher programs. Though it highlights important patterns in student test score ...
(Date:4/25/2017)... ... April 25, 2017 , ... As pharmaceutical companies are held ... with process innovation in drug formulation and manufacturing. CoreRx offers its clients ... equipment in support of their development and manufacturing goals. , The company ...
Breaking Medicine News(10 mins):