CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Cardiac Patch Material
August 12 2009 - 8:30AM
PR Newswire (US)
ATLANTA, Aug. 12 /PRNewswire-FirstCall/ -- CryoLife, Inc.,
(NYSE:CRY) an implantable biological medical device and
cardiovascular tissue processing company, today announced that it
has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its CryoPatch SG pulmonary human cardiac
patch. CryoPatch SG is processed with the Company's proprietary
SynerGraft technology designed to remove allogeneic donor cells and
cellular remnants from tissue without compromising the integrity of
the underlying collagen matrix. 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. "The introduction of CryoPatch SG
represents another step in the broadening applications of the
SynerGraft technology to patients and surgeons," said Steven G.
Anderson, CryoLife's president and chief executive officer.
"CryoPatch SG may offer an attractive tissue reconstruction option
for many children born with heart defects." Management estimates
that the U.S. market for CryoPatch SG and other tissues and
products for the indications listed above is $15 million. CryoLife
anticipates that the first CryoPatch SG will be available for
shipment late in the third quarter of 2009. In February 2008, the
Company received a 510(k) clearance from the FDA for its CryoValve
SG pulmonary human heart valve. CryoValve SG is indicated for the
replacement of diseased, damaged, malformed, or malfunctioning
native or prosthetic pulmonary valves. The valve can be used in
conjunction with right ventricular outflow tract reconstruction
procedures (RVOT), commonly performed in children with congenital
heart defects. In addition, the valve can be used for pulmonary
valve replacement during the Ross Procedure, an operation in which
a patient's defective aortic valve is removed and replaced with his
own pulmonary valve. The CryoValve SG is then surgically implanted
in place of the removed native pulmonary valve. 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.
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. 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. 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 and the anticipated U.S. market
it would address, as well as the timing of use of the SynerGraft
technology. 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, nor may the first
shipments of CryoPatch SG occur as expected, 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/ Media
Contacts: D. Ashley Lee Executive Vice President, Chief Financial
Officer and Chief Operating Officer Phone: 770-419-3355 Katie
Brazel Fleishman Hillard Phone: 404-739-0150 DATASOURCE: CryoLife,
Inc. CONTACT: D. Ashley Lee, Executive Vice President, Chief
Financial Officer and Chief Operating Officer, +1-770-419-3355;
Katie Brazel, Fleishman Hillard, +1-404-739-0150 Web Site:
http://www.cryolife.com/
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