FDA Clears New Immune Response Claim for the CryoValve(R) SG Pulmonary Human Heart Valve
biomaterials, medical device and tissue processing company, announced today
that the U.S. Food and Drug Administration (FDA) has cleared a new claim for
the CryoValve(R) SG pulmonary human heart valve. The new labeling claim
relates to reducing a component of the immune response in recipients of the
CryoValve SG.
CryoValve SG pulmonary human heart valve is processed with the Company’s
proprietary SynerGraft(R) technology, which is designed to remove allogeneic
donor cells and cellular remnants from the valve without compromising the
integrity of the underlying collagen matrix.
The new claim relates to the fact that data from three company-sponsored
clinical studies and a comprehensive review of the scientific literature on
allograft heart valves shows that implantation of the CryoValve SG reduces the
risk of inducing HLA class I and class II alloantibodies, based on Panel
Reactive Antibody (PRA) measured at up to one year, compared to the standard-
processed pulmonary human heart valve. The effect of reduced alloantibodies,
however, on the long-term durability, or long-term resistance to rejection by
the patient, of the CryoValve SG has not yet been clinically proven. The
company has documented the implantation of more than 1,800 CryoValve SG
pulmonary human heart valves.
The CryoValve SG pulmonary human heart valve 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 or
her own pulmonary valve. The CryoValve SG is then surgically implanted in
place of the removed native pulmonary valve.
A PRA screen is used to identify allosensitized patients prior to organ
transplantation. An elevated PRA level, indicating pretransplant
alloantibodies, increases the risk of organ transplant rejection and patient
mortality. In addition, high and prolonged PRA levels may prevent or delay
transplantation until a suitable crossmatch-compatible donor is identified.
“A major objective of our research and development is to reduce and
ultimately eliminate the risk of an immune response for patients, and we are
making great strides toward achieving that goal,” said
president and chief executive officer of CryoLife. “This new claim is
important because a subset of patients receiving an allograft heart valve is
likely to eventually require an organ transplant. Demonstration of reduced
alloantibody levels with the CryoValve SG can be a key consideration for
cardiac surgeons when replacing the pulmonary valve. Working with the FDA, we
will monitor the long-term clinical outcomes over the coming years to assess
what impact the SynerGraft process has on valve durability.”
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
clearance for the CryoValve(R) SG pulmonary human heart valve, processed using
CryoLife’s proprietary SynerGraft(R) Technology in early 2008. 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
MPH(R), a hemostatic agent, in much of the U.S. for use in cardiac and
vascular surgery and in the
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 the expected benefits of
the CryoValve SG and its potential impact on patients as well as the factors
considered by surgeons when replacing a pulmonary valve. These forward
looking statements may not occur as, when or to the extent expected, and are
subject to a number of risk, including the following: CryoValve SG continues
to undergo testing, and additional test results may not yield the anticipated
benefits. Many factors impact the suitability of patients for transplants,
and there can be no guaranty that patients who receive the CryoValve SG will
be more likely to be considered suitable for transplants or have better
results following a transplant. In addition, the factors considered by
surgeons in weighing transplant options may vary and may change over time.
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.