CryoLife Human Heart Valve Clinical Experience Report Demonstrates Positive Long-Term Outcomes
January 20 2005 - 12:41PM
PR Newswire (US)
CryoLife Human Heart Valve Clinical Experience Report Demonstrates
Positive Long-Term Outcomes Comprehensive heart valve registry
tracks more than 2,600 adult and pediatric patients for 10 years
following human heart valve implantation ATLANTA, Jan. 20
/PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE:CRY), a biomaterials
and biosurgical device company, announced updated results from its
registry, tracking clinical performance of its cryopreserved human
heart valve allografts. Data from this registry is used to project
long-term performance by actuarial statistical analysis(1). Results
indicate 100 percent of pediatric patients and 98 percent 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(R) 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 percent 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
pediatric patients, 99 percent were reported to be free from
endocarditis during this period. Also, freedom from valve-related
death within ten years of implantation was 93 percent and 97
percent for adult and pediatric patients, respectively. These
statistics confirm the significant patient benefit conferred by
human cryopreserved heart valve allografts. "We believe CryoLife is
the only company that tracks and publishes long- term clinical
performance of implanted human heart valves. CryoLife's Clinical
Registry, which includes a large number of pediatric and adult
patients, is an important source of information and a valuable tool
for cardiac surgeons," said Steven G. Anderson, President and CEO
of CryoLife, Inc. 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. The study population within the
registry consists of 1,788 males (68%) and 851 females (32%). The
age of the recipients at the time of implant ranged from 1 day to
87 years, with 1,244 (47%) of the patients between the ages of 0-17
years (pediatric patients) and 1,395 (53%) between 18-84 years
(adult patients). The data in the CryoValve Human Heart Valve
Clinical Experience 2004 report, collected and analyzed on a yearly
basis, includes patient survival and freedom from endocarditis,
thromboembolism, and structural valve deterioration. The updated
report is published annually and made available to surgeons and
their patients. Since the Company was founded in 1984, more than
100,000 patients have received CryoLife-processed tissues in
cardiac, vascular, and orthopaedic reconstruction surgical
procedures. More than 47,000 cryopreserved allograft heart tissues
have been implanted at over 800 institutions in the United States,
Canada and Europe. The CryoValve Human Heart Valve Clinical
Experience 2004 report is available on the Company's website,
http://www.cryolife.com/ . 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(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, is CE marked in
the European Community and approved 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
SynerGraft(R)Vascular Graft, which is CE marked for distribution
within the European Community. (1) Definition: Actuarial
statistical analysis is a procedure used to predict the time until
an event occurs. 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
Company's 2004 report may not accurately predict outcomes for
patient populations, that the report may not be a valuable tool for
cardiac surgeons, that the Company's revenues and expenses may not
meet its expectations, that demand for CryoLife preserved tissues
may not improve, the possibility that the FDA could impose
additional restrictions on CryoLife's operations or require a
recall, that the Company may not have sufficient borrowing or other
capital availability to fund its business, that present and future
litigation may be resolved only by substantial payments by the
Company in excess of available insurance coverage, the possibility
of severe decreases in the Company's revenues and working capital,
that to the extent the Company does not have sufficient resources,
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. For additional
information about the company, visit CryoLife's Web site:
http://www.cryolife.com/ Contact: Joseph T. Schepers Vice
President, Corporate Communications (770) 419-3355 DATASOURCE:
CryoLife, Inc. CONTACT: Joseph T. Schepers, Vice President,
Corporate Communications of CryoLife, Inc., +1-770-419-3355 Web
site: http://www.cryolife.com/
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