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CryoLife Receives FDA 510(k) Clearance For SynerGraft(R) Processed Human Pulmonary Heart Valves
CryoLife, Inc., (NYSE: CRY) a
biomaterials, medical device and tissue processing company, 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
CryoLife, Inc.
http://www.cryolife.com
CryoLife FDA a primit 510 (k) Clearance-ul Pentru SynerGraft (R) prelucrate Omului pulmonarã Inimã Robineti - CryoLife Receives FDA 510(k) Clearance For SynerGraft(R) Processed Human Pulmonary Heart Valves - articole medicale engleza - startsanatate