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Bard Announces FDA Clearance of Avitene Ultrafoam Collagen to Stop Bleeding During Surgery.


Business Editors, Health/Medical Writers

MURRAY HILL, N.J.--(BW HealthWire)--March 9, 2000

Unique Product is the Only FDA-Cleared Collagen Sponge

For Use In All Surgical Applications, Including Neurosurgery

C. R. Bard C. R. Bard, Inc. (NYSE: BCR) is one of the large S&P 500 companies of the United States, a surgical specialties and hospital medical device manufacturer in Murray Hill, New Jersey. It is named after its founder, who sold the company within only a few years of its founding.  (NYSE NYSE

See: New York Stock Exchange
:BCR BCR B Cell Receptor
BCR Business Communications Review (magazine)
BCR Banca Comerciala Romana (Romanian bank)
BCR Breakpoint Cluster Region
BCR Benefit/Cost Ratio
BCR Bay City Rollers
) today announced its subsidiary, Davol Inc. has received approval by the Food and Drug Administration to market Avitene(R) Ultrafoam(TM) collagen 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 collagen sponge used to stop bleeding during surgical procedures by accelerating blood clot formation. The Ultrafoam product is the only collagen hemostatic hemostatic /he·mo·stat·ic/ (he?mo-stat´ik)
1. causing hemostasis, or an agent that so acts.

2. due to or characterized by stasis of the blood.


he·mo·stat·ic
adj.
 sponge approved for use in all surgical applications, including neurosurgery, the surgical specialty using topical hemostats hemostats Surgery A hand-held surgical instrument with flattened opposing surfaces used to occlude blood vessels for hemostasis  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 thrombin: see blood clotting. , 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 gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid.  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 Laparoscopic
A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen.

Mentioned in: Obstetrical Emergencies
 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.
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Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Mar 9, 2000
Words:431
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