ATLANTA, Feb. 7 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) a
biomaterials, medical device and tissue processing company, today announced
that it has received 510(k) clearance from the Food and Drug Administration
(FDA) for its CryoValve(R) SG pulmonary human heart valve processed with the
Company's proprietary SynerGraft technology. CryoLife's proprietary
SynerGraft technology is designed to remove allogeneic donor cells and
cellular remnants from the valve without compromising the integrity of the
underlying collagen matrix.
The CryoValve SG pulmonary human heart valve is indicated for the
replacement of diseased, damaged, malformed or malfunctioning native 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.
"CryoValve SG may offer an attractive valve replacement option for many
children born with heart defects," said Steven G. Anderson, CryoLife's
president and chief executive officer. "CryoValve SG may also be a good
option for patients who have undergone valve replacement surgery as young
children, but may require another valve replacement as they've grown into
adulthood."
"Children born with heart defects often face frequent and challenging
surgeries," stated John W. Brown, M.D., professor of Cardiothoracic Surgery,
Indiana University School of Medicine, Indianapolis, Ind. "For certain heart
defects, CryoValve SG may give these kids a great opportunity to live active,
normal lives. As a surgeon, I'm very excited to be able to offer them and
their families this treatment option."
At FDA's request, CryoLife is planning a post-clearance study to seek
evidence for the potential and implied long-term benefits of the SynerGraft
process. Data to be collected is expected to include long-term safety and
hemodynamic function, immune response, and explant analysis. CryoLife believes
that this information may help it ascertain whether the SynerGraft process
reduces the immunogenicity of the transplanted heart valve and recellularizes
with the recipients own cells.
CryoLife will be using the SynerGraft technology for the majority of its
pulmonary valve processing and anticipates that the first CryoValve SG may be
available for shipment late in the first quarter of 2008.
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 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.
BioGlue is also CE marked in the European Community and approved in Canada and
Australia for use in soft tissue repair. The Company also distributes the
CryoLife-O'Brien(R) stentless porcine heart valve, which is CE marked for
distribution within the European Community.
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 CryoValve SG 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
CryoValve SG may not perform as well as expected or provide all of the
benefits anticipated, the Company may not be able to begin processing the
majority of its pulmonary valves by the anticipated time, nor may the first
shipments of CryoValve SG occur as expected, 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, 2006, its most recent Form
10-Q, 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
SOURCE: CryoLife, Inc. 02/07/2008
CONTACT: D. Ashley Lee, Executive Vice President, Chief Financial
Officer and Chief Operating Officer of CryoLife, Inc., +1-770-419-3355; or
Katie Brazel of Fleishman Hillard, +1-404-739-0150
Web site: http://www.cryolife.com
(CRY)