Copyright 1999 Medical Data International, Inc.
Medical Industry Today
February 18, 1999, Thursday
SECTION: DEVICE AND DIAGNOSTICS
LENGTH: 897 words
HEADLINE: CoStasis Launch May Lead to Better Control of Bleeding
BODY:
Surgeons in various parts of Europe soon will have access to a new resource in their efforts to control bleeding.
COHESION TECHNOLOGIES' (Palo Alto, CA) European distributors have launched commercial sales of CoStasis--a liquid hemostat designed to control diffuse surgical bleeding--in Austria, Germany and the United Kingdom. The company received the CE Mark for the product in September.
In the next several months, the company expects to finalize agreements and training programs with more distributors and to roll-out the product into Belgium, Denmark, Finland, France, Italy, the Netherlands, Norway, Portugal and Spain.
The pre-mixed, ready-to-use collagen/thrombin suspension is supplied in one syringe and is mixed with the patient's own plasma from a second syringe at the time of application to the bleeding site. CoStasis remains intact during the critical wound-healing period, and then is absorbed and eliminated by the body.
"We have begun to assemble a distributor network with proven ability to build a market for new, innovative products, and we look forward to bringing the many advantages of CoStasis to physicians and their patients across Europe. During 1998, it is estimated that Europe's 2,000 cardiovascular surgeons performed approximately 300,000 surgical procedures, in which control of bleeding was essential," said Alan Schempp, vice president of sales and marketing, in a statement.
"Surgeons in Europe and Japan have been using fibrin glues and sealants for years to stop bleeding, but these products suffer from a variety of clinical and usage problems that CoStasis specifically addresses."
Compared to current products, CoStasis has several advantages, according to Schempp. He said that they include:
Versatility. CoStasis is designed to be more adherent and elastic than current products, which enables it to bind strongly to various tissue surfaces, including rough and intricate areas.
Easy Preparation. CoStasis is designed as a two-part system, prepared in about 5 minutes just before it is needed.
Ease of Use. CoStasis is a self-polymerizing liquid system with no need for equipment such as light sources or heat for activation or efficacy. And the patent-pending delivery system gives the surgeon flexibility to use the same system throughout the surgical procedure.
Safety. CoStasis uses the patient's plasma, eliminating potential contamination risks inherent with products derived from pooled human sources.
Cost Effectiveness. CoStasis is designed to give the surgeon the flexibility to determine whether to use the product during the surgical procedure. In comparison, current products have lengthy preparation times and require the surgeon to commit to use before a determination of need.
"Our initial shipments of CoStasis this quarter are expected to be modest," Schempp said. "We anticipate that it will take a couple of quarters to gradually broaden our distributor coverage and our range of product configurations in Europe."
Cohesion's sales efforts in Europe are under the direction of Hubert Goossens, who joined the Company last month as director of sales for Europe, the Middle East and Africa.
The company is manufacturing CoStasis at its Palo Alto headquarters.
Meanwhile, the company is pursuing FDA approval for the product. The U.S. pivotal clinical study with CoStasis for treating diffuse bleeding in cardiothoracic, hepatic, general and orthopedic surgical procedures is completed, and the company expects to file a Premarket Approval application with the FDA this spring.
In a statement last month, the company reported preliminary findings from its 300-patient, randomized clinical study conducted at 10 major U.S. medical centers using CoStasis for treatment of bleeding in cardiovascular, hepatic, general and orthopedic surgery procedures.
Preliminary findings showed that CoStasis stopped bleeding in soft tissue applications in about 98 percent of the treated patients within 3 to 10 minutes depending on the surgical site, compared with about 70 percent in the control group treated with a collagen hemostatic sponge. Also, CoStasis stopped bleeding in one-third to one-half the time of the control group. Bleeding stopped in less than 2 minutes from application in more than 70 percent of patients treated with CoStasis, compared with almost 40 percent of the patients in the control group.
The company said that CoStasis also performed well in difficult-to-treat hard tissue bleeding (the sternal edge and iliac crest), as bleeding stopped in more than 85 percent of the treated sites within 3 to 10 minutes depending on the site, compared with about 50 percent for the control group. Furthermore, in more than 70 percent of the hard tissue sites, bleeding was stopped within 2 minutes using CoStasis, compared with about 25 percent for the control group.
CoSeal Surgical Sealant, the company's second product candidate, is being designed to prevent leakage of blood in cardiovascular and vascular surgeries. CoSeal is in preclinical development.
Cohesion Technologies develops products for the surgical hemostasis and sealant markets.
CONTACT: Lisa Morgensai, Cohesion Technologies (650/354-4300)
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LANGUAGE: ENGLISH
LOAD-DATE: February 17, 1999
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