MIV Gets Regulatory Approval For Two Bare Metal Stents in India
November 14, 2007 - MIV Therapeutics Inc. announces that the Drugs Controller General of India (DCGI), the governmental agency with regulatory authority over medical products, has approved two of the Company's bare metal stents for manufacture and sale in India.
The GenX Stainless Steel Coronary Stent and Stent System and the GenX CrCo Chromium Cobalt Coronary Stent and Stent System along with the company's additional angioplasty products will be officially launched into the Indian market at the Cardiological Society of India 59th Annual Meeting beginning December 5th to 9th in Hyderabad and will be available for sale in India through third party distributors.
Dr. Mark Landy, president of MIV Therapeutics, said, "This regulatory achievement permits MIV Therapeutics' entrée into one of the world's fastest growing stent markets with a highly competitive offering, and allows us to continue refining and increasing our manufacturing capability as we advance the clinical development of our unique drug-eluting stents using our advanced biocompatible coatings and drug delivery technology."
The two stents are identical in design and performance with the main difference being strut thickness. The GenX Stainless Steel Coronary Stent has a strut thickness of 105 microns making it one of the thinnest-strut stainless steel stents available today. The GenX CrCo Chromium Cobalt Coronary Stent has a strut thickness of 65 micron, placing it amongst the thinnest-strut stents available today. Strut thinness has long been regarded as an important stent design feature as it reduces injury and aids re-endothelialization leading to lower restenosis and thrombosis rates.
For more information: www.mivtherapeutics.com
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