ATLANTA, Aug. 18 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an
implantable biological medical device and cardiovascular tissue processing
company, today announced the first three implantations of the CryoPatch SG
pulmonary human cardiac patch since FDA clearance. The surgeries were
performed on pediatric patients at the University of Michigan C.S. Mott
Children's Hospital in Ann Arbor, MI by Richard G. Ohye, M.D., associate
professor of surgery, division head, pediatric cardiovascular surgery and
pediatric cardiac surgeon, University of Michigan Congenital Heart Center.
CryoPatch SG is the third tissue processed using CryoLife's SynerGraft
technology platform to receive FDA clearance. The proprietary technology is
designed to remove allogeneic donor cells and cellular remnants from tissue
without compromising the integrity of the underlying collagen matrix.
"We are very excited that SynerGraft technology is now available in
cardiac patch materials for our pediatric patients," said Dr. Ohye, "We are
hopeful the special processing these patches undergo will lessen the body's
reaction to them and prevent future complications associated with the
currently available material."
"At CryoLife, our ongoing goal is to provide surgeons and their patients
with innovative options that will enhance recovery and restore health," said
Steven G. Anderson, CryoLife's president and chief executive officer. "The
CryoPatch SG, part of our growing portfolio of SynerGraft products, is an
important step toward that goal, as it may offer a tissue reconstruction
material that mitigates many of the future health issues faced by children
born with heart defects."
About CryoPatch SG
CryoPatch SG is indicated for the repair or reconstruction of the right
ventricular outflow tract (RVOT), which is a surgery commonly performed in
children with congenital heart defects, such as Tetralogy of Fallot, Truncus
Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three
anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary
branch.
Implantation of the CryoPatch SG reduces the risk for induction of HLA
class I and class II alloantibodies, based on Panel Reactive Antibody (PRA)
measured at up to one year, compared to standard processed pulmonary cardiac
tissues. Data have not been provided to evaluate the effect of reduced
alloantibodies on the long-term durability, or long-term resistance to
rejection by the patient, of the CryoPatch SG.
Avoiding elevated PRA is important for patients receiving CryoPatch SG as
some may ultimately require a heart transplant. While the link between immune
response and allograft tissue performance is still being debated, there is
evidence that an elevated PRA poses a significant risk to future organ
transplant patients. In these patients, an increased PRA can decrease the
number of possible donors for subsequent organ transplants, and increase time
on transplant waiting lists.
Please visit the CryoLife website at www.cryolife.com for additional
information about the SynerGraft technology and CryoPatch SG.
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 U.S. and Canada. The Company's CryoValve
SG pulmonary human heart valve, processed using CryoLife's proprietary
SynerGraft technology, has FDA 510(k) clearance for the replacement of
diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary
valves. 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. BioGlue is also CE marked in the European Community
and approved in Canada and Australia for use in soft tissue repair. The
Company's BioFoam Surgical Matrix is CE marked in the European Community for
use as an adjunct in the sealing of abdominal parenchymal tissues (liver and
spleen) when cessation of bleeding by ligature or other conventional methods
is ineffective or impractical. BIOGLUE Aesthetic(TM) Medical Adhesive is CE
marked in the European Community for periosteal fixation following endoscopic
browplasty (brow lift) in reconstructive plastic surgery and is distributed by
a third party for this indication. CryoLife distributes HemoStase(TM), a
hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery
and in the European Community and Canada for cardiac, vascular, and general
surgery, subject to certain exclusions.
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 statements include those regarding anticipated effectiveness,
benefits and indications for use of CryoPatch SG. 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 CryoPatch SG may not perform as well as expected or
provide all of the benefits anticipated, that the CryoPatch SG has a one year
shelf life, 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, 2008, our Form 10-Q for the quarter ended March 31,
2009, our Form 10-Q for the quarter ended June 30, 2009, 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
SOURCE: CryoLife, Inc.
- 08/18/2009
CONTACT:
D. Ashley Lee, Executive Vice President,
Chief Financial Officer and Chief Operating Officer,
+1-770-419-3355; or
Katie Brazel,
Fleishman Hillard, +1-404-739-0150
Web Site: http://www.cryolife.com
(CRY)
