FDA Clears New Immune Response Claim for the CryoValve(R) SG Pulmonary Human Heart Valve
February 17 2009 - 8:30AM
PR Newswire (US)
ATLANTA, Feb. 17 /PRNewswire-FirstCall/ -- CryoLife, Inc.
(NYSE:CRY), a 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
Steven G. Anderson, 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 Canada. The Company received FDA 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 Canada and Australia for use in
soft tissue repair. CryoLife distributes Hemostase MPH(R), a
hemostatic agent, in much of the U.S. for use in cardiac and
vascular surgery and in the United Kingdom, Germany, France, 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 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 DATASOURCE: CryoLife, Inc. 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/
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