MEDICAL MATERIALS UPDATE
March, 1999
SECTION: BIOLOGICALS; Vol. 6, No. 2
LENGTH: 438 words
HEADLINE: Cohesion Technologies Begins Coseal Study
BODY:
According to an article in the Palo Alto, California BW HealthWire (March 1, 1999) Cohesion Technologies (2500 Faber Place, Palo Alto, CA 94303; Tel: 650/354-4300, Fax: 650/354-4675) has begun its feasibility study for its trademarked CoSeal surgical sealant, designed to seal anastomotic sites in vascular and cardiovascular surgery. The feasibility study is being conducted at three sites in Europe, and will include up to 15 patients undergoing peripheral vascular surgery, such as grafting procedures. The clinical endpoint of the feasibility study will be to time the cessation of leakage.
Based on proprietary hydrogel technology, CoSeal surgical sealant is designed to bond strongly and rapidly to tissue, forming a seal that prevents blood leakage in cardiovascular and vascular surgeries. CoSeal surgical sealant 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 five minutes. The product is totally synthetic and is completely resorbed within 30 days. Patient enrollment is expected to be completed within four to six weeks. With favorable results, the company will begin a larger, pivotal clinical trial in Europe.
"This product, even in its early concept phase, received very favorable responses from surgeons who observed product demonstrations," said David Foster, CEO. "Surgical repair necessitates the opening or puncturing of body cavities, organs and vessels, and compromises barriers that normally prevent leakage in the body. The consequences of this leakage can range from minor inconvenience to life-threatening events, and can be especially serious in vascular and cardiovascular surgical procedures. We believe CoSeal surgical sealant may offer surgeons significant competitive advantages including that (it) is completely synthetic, takes about five minutes to prepare, and self-polymerizes at the surgical site in seconds."
Cohesion Technologies is developing products for the estimated $ 1.3 billion worldwide surgical hemostasis and sealant markets. CoSeal surgical sealant is the second product developed by Cohesion. The first, its trademarked CoStasis surgical hemostat designed to treat diffuse bleeding, was recently commercialized in selected European countries. A U.S. pivotal clinical trial with CoStasis surgical hemostat for the treatment of diffuse bleeding in cardiothoracic, hepatic, general, and orthopedic surgical procedures was recently completed, and the company expects to file a pre-market approval application with the FDA in the spring of 1999.
LANGUAGE: ENGLISH
LOAD-DATE: March 26, 1999
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