This seems to be a significant product. In fact, BCR claims it is the only product like this to be available in the market.
biz.yahoo.com
Thursday March 9, 3:26 pm Eastern Time
Company Press Release
Bard Announces FDA Clearance of Avitene Ultrafoam Collagen to Stop Bleeding During Surgery
Unique Product is the Only FDA-Cleared Collagen Sponge For Use In All Surgical Applications, Including Neurosurgery
MURRAY HILL, N.J.--(BW HealthWire)--March 9, 2000-- C. R. Bard (NYSE:BCR - news) today announced its subsidiary, Davol Inc. has received approval by the Food and Drug Administration to market Avitene© Ultrafoam(TM) collagen hemostat, a collagen sponge used to stop bleeding during surgical procedures by accelerating blood clot formation. The Ultrafoam product is the only collagen hemostatic sponge approved for use in all surgical applications, including neurosurgery, the surgical specialty using topical hemostats most frequently.
Hemostatic agents are used extensively across a broad range of surgical procedures, but predominantly in spine, neuro, and vascular surgery. According to IMS Health, Inc., a national marketing research firm, more than 5 million hemostatic agents are used annually in the United States, alone, to:
-- Provide the surgeon with better visibility during the surgical procedure by minimizing the collection of blood at the operative site;
-- Minimize the patient's blood loss; and
-- Prevent post-operative complications due to hemorrhage.
Unlike other hemostatic sponges on the market that require the addition of thrombin, a liquid clotting agent to control bleeding, the Ultrafoam sponge is made from Avitene collagen, a natural clotting agent. Use of Ultrafoam collagen dramatically reduces preparation time and the patient's risk of a potentially hazardous reaction to bovine thrombin.
The physical characteristics of the Ultrafoam product provide the surgeon with a soft, pliable sponge that conforms to various and irregular anatomical structures. The Ultrafoam hemostat is available in five different sizes, is ready to use out of the package, and provides an economic advantage over the use of gelatin sponges combined with thrombin to control bleeding.
``The Ultrafoam sponge is an exciting, new technology from Bard's R&D pipeline that complements our existing Avitene product line - considered a premium hemostatic product by the surgical community for more than 25 years,' said Bard Chairman and Chief Executive Officer William H. Longfield. ``FDA's approval of our Ultrafoam product represents a significant step toward Bard's objective to obtain global market leadership in surgical specialty products,' Longfield said. ``Now, for the first time, surgeons in all specialties have access to a full line of collagen hemostats designed for both open and laparoscopic procedures,' he
explained.
Davol Inc. is the only medical technology company to offer a full line of collagen hemostats indicated for all surgical specialties, designed for use in open and laparoscopic procedures. C. R. Bard, Inc., with headquarters in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of health care products. |
