CryoLife Announces First SynerGraft -R- Biologic Heart Valve Implants in Human Patients; Trans-species Transplant Performed Without Use of Immunosuppression
CryoLife's SynerGraft technology incorporates the use of a
porcine heart valve which is depopulated of its cells and is expected
by the Company to repopulate following implantation with the cells of
the heart valve recipient, producing a bio-engineered human heart
valve similar to the patient's own heart valve.
Steven G. Anderson, President and Chief Executive Officer of
CryoLife, said, "I believe the successful implant of a
tissue-engineered heart valve is an enormous milestone for our company
and our SynerGraft technology. The SynerGraft technology has multiple
applications, but holds particular promise for cardiac surgery in
children since we believe that the bio-engineered heart valve should
have the capability to remodel itself with the recipient's own cells,
potentially growing with the child. I believe the implantation of a
tissue-engineered heart valve represents a revolutionary breakthrough
in implantable device technology. SynerGraft technology enables a
trans-species transplant of an unfixed biologic heart valve without
requiring the use of immunosuppression."
Mark O'Brien, M.D., of the Department of Cardiac Surgery at The
Prince Charles Hospital, Brisbane, Australia, said, "The implantation
of these two heart valves, which took place one week ago, is a
landmark event in heart surgery. To our knowledge, these are the first
implantations of tissue-engineered heart valves in the world. This
SynerGraft technology may revolutionize the replacement of heart
valves, making life-saving surgery available to expanded numbers of
patients."
Founded in 1984, CryoLife, Inc. is the leader in the development
and commercialization of living human tissue implantable devices for
use in cardiovascular, vascular and orthopaedic surgeries throughout
the United States and Canada. The Company's BioGlue(R) surgical
adhesive, CE marked in the European Union for use in vascular and
pulmonary sealing and repair, is distributed throughout Europe. The
Company also manufactures CryoLife-O'Brien(R) and CryoLife-Ross(TM)
stentless porcine heart valves which are distributed within the
European Community.
Statements made in this press release which look forward in time
involve risks and uncertainties and are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. Such risks and uncertainties include the possibility that the
implanted SynerGraft valve will not repopulate with the cells of the
recipient, or even if repopulated, that the valve will not grow with
pediatric recipients, the risk that the SynerGraft valve will
otherwise not perform as expected and will therefore not become an
acceptable alternative to currently available implantable valves,
changes in economic cycles, competition from other companies, changes
in laws and governmental regulations applicable to the Company and
other risk factors detailed in the Company's Securities and Exchange
Commission filings, including the Company's Form 10-K for the year
ended December 31, 1998.
The Company web site is: http://www.cryolife.com
Editor's Note:
Historical timeline of heart valve replacements:
Mechanical heart valve implant - 1960
Fresh homograft implant - 1962
Stented porcine(1) heart valve implant - 1968
Stented bovine(1) pericardial implant - 1981
Cryopreserved(2) homograft implant - 1984
Stentless porcine(1) heart valve implant - 1988
Tissue engineered(3) heart valve implant - 1999
(1) Glutaraldehyde fixation
(2) Commercially available
(3) SynerGraft technology
CONTACT: CryoLife Inc., Atlanta
Roy Vogeltanz, 800/438-8285