COHESION GETS CE MARK FOR COSEAL SURGICAL SEALANT.Cohesion Technologies (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NM: CSON CSON Connell School of Nursing (Boston College) ), Palo Alto, Calif., has received the CE Mark for CoSeal surgical sealant, which permits sales into the countries comprising the European Union. CoSeal is a resorbable synthetic sealant for use in sealing vascular grafts. Receipt of the CE Mark followed review of clinical data from 10 medical centers in Europe. Data involving 202 treated sites and 125 patients showed that sealing was achieved in 96% of procedures, which included peripheral bypass grafts, AV-shunts and femoral femoral /fem·o·ral/ (fem´or-al) pertaining to the femur or to the thigh. fem·o·ral adj. Of or relating to the femur or thigh. arteriotomy sites for endovascular procedures. Sealing with CoSeal was immediate in 68% of the procedures, with 92% sealing in less than three minutes. "I utilized CoSeal in a number of surgeries involving PTFE PTFE polytetrafluoroethylene. grafts. PTFE is an excellent grafting material; however, it is notorious for leaking and because of PTFE's "no-stick" surface, it is very difficult to seal with conventional methods. I liked CoSeal because it worked very well -- sealing all of the graft sites, quickly and very easily. I believe that CoSeal holds potential to reduce surgical time and post-surgical complications, and the synthetic nature provides additional safety to my patient," said Dr. Alexander C. de Vries, a CoSeal clinical investigator, Westeinde Hospital in The Hague, The Netherlands. Based on proprietary hydrogel hy·dro·gel n. A colloidal gel in which the particles are dispersed in water. hydrogel a gel that contains water. hydrogel Wound care A polymer absorptive wound dressing. See Dressing. technology, CoSeal is designed to bond strongly and rapidly to tissue and graft material such as PTFE, forming a seal that prevents blood leakage at graft sites. CoSeal is a self-polymerizing gel that does not require additional equipment such as light sources or heat for activation. The delivery system is easily prepared in less than three minutes. The product is completely synthetic and is resorbed within 30 days. "CoSeal is based on an entirely different technology platform than our first product for hemostasis, and furthers the Company's goal of being the surgeon's first choice for next-generation hemostats hemostats Surgery A hand-held surgical instrument with flattened opposing surfaces used to occlude blood vessels for hemostasis , sealants, adhesives and adhesion barriers," stated David Foster, chief executive officer of Cohesion Technologies. "CoSeal offers vascular and cardiovascular surgeons important advantages compared with products currently available in Europe, including a two to three minute preparation time, rapid self-polymerization of the sealant, and the lower risk of a completely synthetic, biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. product." CoSeal will be sold in Europe through a distributor network, with initial sales and introductions of CoSeal expected to begin in late April on a country-by-country basis. In the U.S., Cohesion began U.S. clinical studies with CoSeal last month and anticipates filing a CoSeal Premarket Approval ("PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ") application with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. at the end of this year. In addition to CoSeal(tm) surgical sealant, Cohesion Technologies has also developed CoStasis(tm) surgical hemostat hemostat /he·mo·stat/ (he´mo-stat) 1. a small surgical clamp for constricting blood vessels. 2. an antihemorrhagic agent. he·mo·stat n. 1. , a liquid sprayable gel used to stop or control surgical bleeding. U.S. Surgical has marketing rights to CoStasis throughout North America, Europe, Latin America, Australia and selected countries. CoSeal(tm) surgical sealant and CoStasis(tm) surgical hemostat are registered trademarks of Cohesion Technologies, Inc. Cohesion Technologies discovers, develops and commercializes innovative resorbable biodevices, adhesive technologies and delivery systems in the fields of tissue repair and regeneration. The Company is developing products for the estimated $1.3 billion worldwide surgical hemostasis and sealant markets. For more information on Cohesion Technologies, visit www.cohesiontech.com or call (650)320-5633. |
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