ATLANTA, June 29 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced that, according to company data, CryoLife's BioGlue(R) Surgical Adhesive has been used in more than 500,000 surgical procedures throughout the world since its introduction into the international market in 1998 and in the United States in 2001. BioGlue is a leading surgical adhesive used in cardiovascular surgeries worldwide.
"I have been using BioGlue since its market introduction almost 10 years ago," said Dr. John W. Fehrenbacher, Methodist Hospital, Indianapolis, Ind. "I have utilized BioGlue in over 1,000 patients undergoing a variety of cardiac procedures including valve replacements, aneurysm repair, and aortic dissection repair. I find that BioGlue is safe, easy to use, and because of its effectiveness at reducing anastomotic bleeding, has allowed me to change the way I perform many of my aortic aneurysm procedures."
A two-component adhesive, BioGlue creates a flexible, mechanical seal, independent of the body's clotting mechanism. BioGlue comes in a self-contained, disposable syringe that is available in 2mL, 5mL, and 10mL volumes. Ergonomically designed, the delivery system allows for simple preparation and ease of use.
"The use of BioGlue has continued to grow as surgeons around the globe have experienced its highly effective sealing properties during complex procedures," said Steven G. Anderson, president and CEO of CryoLife. "We anticipate the continued adoption of BioGlue as an essential component of the surgical toolkit, particularly as it is approved for additional indications."
BioGlue is currently approved by the U.S. Food and Drug Administration as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. It is used most commonly in the U.S. for complex cardiovascular procedures involving aortic aneurysms, valve replacements and aortic dissections, as well as peripheral vascular procedures, such as carotid endarterectomy, and arteriovenous access.
In the international market, BioGlue is indicated for use in cardiac and vascular procedures as well as for repair of other soft tissues, including pulmonary, genitourinary, dural, alimentary (esophageal, gastrointestinal, and colorectal), and other abdominal tissues (pancreatic, splenic, hepatic, biliary). It is also used in the fixation of surgical meshes in hernia repair.
BIOGLUE Aesthetic(TM) Medical Adhesive is CE marked in the European Community for periosteal fixation following endoscopic browplasty (brow lift) in reconstructive plastic surgery and is distributed by a third party for this indication.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company's CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. BIOGLUE Aesthetic(TM) Medical Adhesive is CE marked in the European Community for periosteal fixation following endoscopic browplasty (brow lift) in reconstructive plastic surgery and is distributed by a third party for this indication. CryoLife distributes HemoStase(TM), a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the European Community and Canada for cardiac, vascular, and general surgery, subject to certain exclusions.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include those regarding BioGlue's anticipated continued adoption and approval for additional indications. These risks and uncertainties include that we are significantly dependent on revenues from BioGlue and there are a variety of risks affecting BioGlue; the risk of not obtaining additional approvals on a timely basis or at all due to testing results proving disappointing, additional costs, and requirements or trials that might be imposed; the risk that adoption by doctors can be negatively impacted by numerous factors including adverse publicity and competing products; that uncertainties related to patents and protection of proprietary technology may adversely affect the value of our intellectual property; we may not be successful in obtaining necessary clinical results and additional regulatory approvals for products and services in development, and our new products and services may not achieve market acceptance; and that rapid technological change could cause our services and products to become obsolete. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K filing for the year ended December 31, 2008, our most recent Form 10-Q, and the Company's other SEC filings. The Company does not undertake to update its forward-looking statements.
For additional information about the Company, visit CryoLife's Web Site: http://www.cryolife.com.
CONTACT: D. Ashley Lee Katie Brazel Executive Vice President, Chief Financial Fleishman Hillard Officer and Chief Operating Officer Phone: 404-739-0150 Phone: 770-419-3355
|SOURCE CryoLife, Inc.|
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