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Human heart valve clinical experience reports positive outcomes: CryoLife
Atlanta | Monday, January 24, 2005, 08:00 Hrs  [IST]

CryoLife, Inc., a biomaterials and biosurgical device company, announced updated results from its registry, tracking clinical performance of its cryopreserved human heart valve allografts.

According to a company release, data from this registry is used to project long-term performance by actuarial statistical analysis. Results indicate 100 per cent of paediatric patients and 98 per cent of adult patients receiving human heart valves processed by the Company were reported to be free from thromboembolic (blockage) events for a period of ten years following implantation. These and other patient outcomes were detailed in the Company's CryoValve Human Heart Valve Clinical Experience 2004 report, an annual publication tracking more than 2,600 patients receiving human heart valves processed by CryoLife for a period of ten years following the implant.

Additionally, 95 per cent of adult recipients of heart valves processed by the Company were reported to be free from endocarditis, an inflammation of the lining of the heart and its valves, for ten years following the implant procedure. For paediatric patients, 99 per cent were reported to be free from endocarditis during this period. Also, freedom from valve-related death within ten years of implantation was 93 per cent and 97 per cent for adult and paediatric patients, respectively, the company release says.

A registry is maintained on a subset of CryoLife allograft heart valves implanted in the United States to provide ongoing clinical data useful to surgeons in making informed decisions on the most appropriate surgical procedure for patients in need of a heart valve replacement, particularly for children with congenital heart defects. Seven implanting institutions throughout the United States participate in this registry. Cryopreserved human heart valve allografts do not require the use of anticoagulant drug therapy and so are considered the heart valve of choice for active young adults, women of childbearing age and for children under the age of 15.

CryoLife, Inc. is involved in the processing and distribution of implantable living human tissues for use in cardiovascular and vascular surgeries throughout the United States and Canada.

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