CryoLife Announces First Implant Of Combination Aortic-Mitral Allograft Heart Valve At The Cleveland Clinic

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 14 May 2008 - 0:00 PDT

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CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced the first implantation of the combination aortic-mitral allograft heart valve in a patient at the Cleveland Clinic. The surgery was performed by Dr. Jose Navia, a cardiac surgeon with the Heart and Vascular Institute at the Cleveland Clinic.

The method used to process the combination aortic-mitral human heart valve was developed by CryoLife in collaboration with the Cleveland Clinic. The innovative valve was developed as a replacement option for patients with infective endocarditis involving both the aortic and mitral valves. Infective endocarditis is a condition in which the structures of the heart, particularly the heart valves, are infected.

"Infections involving both the mitral and aortic valves put patients at very high risk for serious complications that can result in death," said Dr. Navia. "With the new human tissue combination aortic-mitral heart valve, we are hoping to provide an infection-resistant treatment option to offer patients."

Dr. Navia developed the concept for the aortic and mitral valve replacement option and is a paid consultant for CryoLife.

"It was very exciting to work closely with the Cleveland Clinic on this breakthrough development in cardiac reconstruction procedures," said Steven G. Anderson, president and CEO of CryoLife. "At CryoLife, we are dedicated to advancing technology for the treatment of patients suffering from complex cardiac disease. The new aortic-mitral allograft heart valve is a wonderful new option for patients suffering from infective endocarditis."

About Infective Endocarditis

Infective endocarditis is a condition in which the structures of the heart, particularly the heart valves, contain some type of infection. This infection can be localized within the heart, or generalized throughout the body. Blood clots can form as a result of this infection. Valve dysfunction is common and can involve the aortic, mitral or tricuspid valves.

In patients with endocarditis, abscesses may also form in areas surrounding the valves and between the mitral and aortic valve. Surgical treatment of this condition involves removal of infected and dead tissue, drainage and closure of any abscesses, and repair, or more frequently, replacement of the affected valves.

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 United States and Canada. The Company recently received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) Technology. 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. CryoLife distributes Hemostase MPH, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the United Kingdom and Germany for cardiac, vascular and general surgery, subject to certain exclusions. The Company also distributes the CryoLife-O'Brien(R) stentless porcine heart valve, which is CE marked for distribution within the European Community.

The Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes, including statements regarding the potential benefits of a combination aortic-mitral allograft heart valve, 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 are subject to various risks and uncertainties. These risks and uncertainties include the risk that the combination valve's resistance to infection may not meet expectations, the combination valve may not function in patients as expected and there may not be significant demand for the valve. 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.

CryoLife, Inc.
http://www.cryolife.com