FDAnews Device Daily Bulletin
March 8, 2005 | Vol. 2 No. 47
Results from the REALITY trial presented at the American College of Cardiology Annual Scientific Session found that Cordis' Cypher Sirolimus-eluting Coronary Stent was associated with development of significantly fewer blood clots at the stent site (stent thromboses) than the Boston Scientific/Angiotech Taxus Paclitaxel-eluting Coronary Stent.
Conor Medsystems presented angiographic and clinical data from the company's pivotal EuroSTAR study evaluating its CoStar cobalt chromium paclitaxel-eluting stent in a complex patient cohort.
William Wijns, the co-principal investigator of the Endeavor II pivotal clinical trial and co-director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium, presented positive results of the Endeavor II trial at the American College of Cardiology 54th Annual Scientific Session.
Kensey Nash has received CE Mark approval for a new triActiv FX System, allowing sale of the product throughout the European Union.
IRIS International, a manufacturer and marketer of automated IVD urinalysis systems and medical devices used in hospitals and reference clinical laboratories worldwide, has announced the launch and first shipment of its iQ200 Sprint, the fastest automated urine microscopy analyzer on the market.
Images, a provider of enterprise-wide advanced visualization software, is introducing ViTALCardia, a technology solution designed specifically for cardiologists. ViTALCardia includes high-powered software for diagnosis as well as a Web-based thin-client distribution technology to provide access to images throughout the cardiology enterprise.
Matritech, a developer of proteomics-based diagnostic products, has entered into an agreement providing for a $12.55 million private placement for the sale of 1,426,124 shares of its Series A Convertible Preferred Stock, each share of which is convertible into 10 shares of common stock, and five-year warrants to purchase 4,991,382 shares of common stock at an exercise price of $1.47 per share.
Biotechnology company Chiron said that it settled a suit against a licenser of cystic fibrosis products that will require the company, SourceCF, to attach a warning label on promotional materials for an electronic inhaler.
ReGen Biologics, an orthopedic products company that develops, manufactures and markets innovative products for human tissue repair in the U.S. and abroad, has announced that the company has regained its rights to exclusively market and distribute its patented Collagen Meniscus Implant throughout the world.
Baxa announces the release of new packaging configurations for its amber Exacta-Med Oral Dispensers.
Boston Scientific has completed its acquisition of Advanced Stent Technologies (AST) of Pleasanton, Calif., for an initial payment of $120 million payable in Boston Scientific stock, plus the possibility of future contingent payments.
Vascular Solutions has received notification from the Japanese Ministry of Health, Labor and Welfare of regulatory approval for the Pronto extraction catheter.
Criticare Systems has announced the release of a new technology platform for noninvasive blood pressure measurement utilizing a traditional BP cuff.
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