Healthcare Industry News:  CV Therapeutics 

Devices Interventional Cardiology Regulatory

 News Release - March 24, 2008

SJTRI Coronary Stent Research Leads to CE Mark Approval for Bare Metal Stent

ATLANTA--(HSMN NewsFeed)--The scientific staff at Saint Joseph’s Translational Research Institute (SJTRI) has announced that a new thin, bare metal stent (BMS) has been approved for sale by European Union regulators. Medlogics Device Corporations’ COBRA™ Coronary Stent System received the CE Mark based on the chronic preclinical implants performed at SJTRI which demonstrated the safety and efficacy of the stent.

The COBRA™ Coronary Stent System combines a unique design and an advanced cobalt super alloy for thinner struts without sacrificing radial strength. Published studies have demonstrated a direct correlation between strut thickness and restenosis rates and the COBRA stent is approximately 15 percent thinner than the best-selling BMS coronary stents. “The COBRA stent shows excellent vascular compatibility with minimal inflammation in the coronary artery preclinical model” says Keith Robinson, PhD, director of preclinical research at SJTRI.

In addition to working their BMS program, SJTRI is conducting further research with Medlogics on their drug-eluting stent programs. “The impressive preclinical results and the subsequent approval of the COBRA stent is an important milestone for Medlogics as the stent is the chassis for their drug-eluting stent program,” continues Dr. Robinson.

Medlogics’s drug-coated stent has a silica-based coating that is gradually absorbed by the body after delivery of the drug, potentially reducing the risk of clotting and the burden of pharmacotherapy.

Medlogics recently announced that it has licensed CV Therapeutics’ proprietary biopolymer stent coating technology for the development of a next-generation based on the COBRA™ platform. Based on preclinical data also obtained through SJTRI, CV Therapeutics proprietary biopolymer stent coating technology could potentially improve the performance of these drug-eluting stents by controlling the drug release rate more precisely. The proprietary manufacturing process used to create the biopolymer may limit or reduce cracking and peeling following expansion of the stent during implantation.

SJTRI continues to be involved in investigating highly innovative medical concepts which may lead to enhancing lifestyles of patients with challenging diseases. Through collaborations lead by a world class staff, SJTRI utilizes unique research applications for evaluating physiologic responses to endolumenal stents in addition to trackability, comformability and radiopacity.

About SJTRI:

Saint Joseph’s Translational Research Institute (SJTRI) is a specialty research organization (SRO) engaged in academic and industry-sponsored research in both preclinical and clinical settings. Our innovative work helps move potential therapies, devices and drugs from the laboratory bench to the patient bedside faster using all available resources of the Saint Joseph’s Health System.

About Medlogics:

Medlogics, with headquarters in Santa Rosa, CA, is dedicated to providing safe and effective clinically superior devices to patients and their physicians worldwide. Medlogics was founded upon the principle of designing innovative, best-in-class solutions to local drug delivery. Medlogics is currently focused on developing a next-generation drug-eluting stent technology to treat coronary artery disease using a novel stent and drug-delivery approach. To help accomplish this goal, Medlogics has vertically integrated drug-eluting coating, stent, and catheter research & development, and manufacturing.

Source: Saint Joseph's Translational Research Institute

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