CryoLife Announces Implants of First FDA-Cleared SynerGraft(R) Processed Human Cardiac Patch Material
18 August 2009 - 2:30PM
PR Newswire (US)
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
http://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/ D. Ashley Lee Katie
Brazel Executive Vice President, Chief Fleishman Hillard Financial
Officer and Chief Phone: 404-739-0150 Operating Officer Phone:
770-419-3355 DATASOURCE: CryoLife, Inc. 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/
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