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BioGlue(R) Surgical Adhesive is Safe and Effective in Range of Cardiac Surgical Procedures

Published on 2004-04-28. Author : SpecialChem

 

CryoLife, Inc., (NYSE: CRY - News) a bio-surgical device and human tissue processing company, announced the presentation of clinical data results supporting positive clinical performance of BioGlue® Surgical Adhesive as a hemostatic adjunct in aortic valve and proximal aortic surgery. In this single-surgeon consecutive series, use of BioGlue Surgical Adhesive helped facilitate a minimal reliance on blood products and a low mortality rate for patients undergoing complex aortic valve and proximal aortic surgical procedures. This presentation was one of two studies reporting on the surgical use of BioGlue presented at the Ninth Aortic Surgery Symposium in New York, New York.

"The results of this study reinforce the value of incorporating BioGlue as an essential component of complex cardiac procedures," said John Fehrenbacher, M.D., cardiothoracic surgeon, Methodist Hospital of Indiana, and lead study investigator. "Use of this surgical adhesive has proven to be an effective method of decreasing the risk of bleeding complications."

The single-center study reviewed the results of 92 patients, predominantly male, between the ages of 23 and 85 who had undergone cardiac surgical procedures including ascending arch repairs, ascending root repairs and Ross procedures. In all cases, BioGlue Surgical Adhesive was used as a hemostatic and structural adjunct to standard surgical methods. Of the 92 patients, 11 patients required no perioperative blood products (12 percent), and the mortality rate for this series was 2.2 percent. No device-related complications were observed. There was one incidence of post-operative pseudoaneurysm (1.1 percent) in a patient who presented with an acute Type A aortic dissection.

Additional clinical information was presented by Dr. Fehrenbacher demonstrating the use of BioGlue Surgical Adhesive during an aortic homograft implantation, which simplified the surgical procedure and resulted in an excellent clinical outcome.
In this case study, a 72-year old female with aortic insufficiency required replacement of her aortic valve due to severe aortic stenosis. A 22 mm aortic homograft was implanted as a full root to provide the patient with the maximum aortic outflow tract, while the adjunctive application of BioGlue Surgical Adhesive helped to prevent the intraoperative bleeding. Postoperatively, the patient had normal valve hemodynamic function.

"The ability of BioGlue to rapidly and effectively prevent bleeding at the surgical site helped simplify this procedure and reduce the chances of post- operative complications for this high-risk patient," said Dr. Fehrenbacher. "Our positive experience working with BioGlue makes it an integral part of certain cardiac procedures."

"BioGlue has consistently performed well in the operating room, and as a result we're anticipating a continued trend of increased use by cardiac and vascular surgeons this year," said Steven G. Anderson, president and chief executive officer, CryoLife, Inc. "BioGlue revenue increased by 33% to $27.8 million in 2003 compared to 2002 and we expect revenues to increase to $32 to $34 million in 2004. Excellent market acceptance and the anticipated introduction of a new innovative delivery system this year clearly indicate a very successful future for BioGlue. "

About BioGlue

BioGlue Surgical Adhesive is a two-component adhesive composed of purified bovine serum albumin (BSA), a cow protein, and a chemical called glutaraldehyde. BioGlue Surgical Adhesive employs a unique delivery system, incorporating a single pre-filled cartridge and applicator device, providing the surgeon complete control of the adhesive at the surgical site.
BioGlue begins creating a flexible mechanical seal independently of the body's clotting mechanism within 20 to 30 seconds, and reaches its maximum bonding strength in two minutes.

In December 2001, the U.S. Food and Drug Administration (FDA) approved BioGlue Surgical Adhesive to be used as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels such as the aorta, femoral and carotid arteries.

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiovascular and vascular surgeries throughout the United States and Canada. The Company's BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels and is CE marked in the European Community, and much of Latin America, and in Canada for use in soft tissue repair and approved in Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SG Model #100 vascular graft, which is CE marked for distribution within the European Community.

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 future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. These risks and uncertainties include that the use of BioGlue may not prove to be as effective as the recent study indicates, that the Company's 2004 BioGlue revenues may not meet its expectations, that the Company's new BioGlue syringe delivery device may not meet expectations, that demand for CryoLife preserved tissues may not return to prior levels, the possibility that the FDA could impose additional restrictions on the Company's operations, require a recall, or prevent the Company from processing and distributing tissues or manufacturing and distributing other products, that the Company may not have sufficient borrowing or other capital availability to fund its business, that pending litigation cannot be settled on terms acceptable to the Company, that the Company may not have sufficient resources to pay punitive damages which are not covered by insurance or liabilities in excess of available insurance, the possibility of severe decreases in the Company's revenues and working capital, that to the extent the Company does not have sufficient resources to pay the claims against it, it may be forced to cease operations or seek protection under applicable bankruptcy laws, changes in laws and regulations applicable to CryoLife and other risk factors detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2003, and the Company's other SEC filings. The Company does not undertake to update its forward-looking statements.

Source:CryoLife, Inc.


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