Navigation Links
CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Pulmonary Heart Valves
Date:2/7/2008

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.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. CryoLife Names Philip Theodore as Vice President, General Counsel
2. CryoLife to Present at Bear Stearns Healthcare and First Albany Capitals Regenerative Technologies Conferences in New York
3. CryoLife Signs Distribution Agreement for Inclusion of BioGlue(R) Surgical Adhesive in Hernia Repair Kit with Proxy Biomedical Surgical Meshes
4. CryoLife Announces Preliminary Third Quarter 2007 Revenues of Approximately $21.9 Million
5. CryoLife to Conduct Annual Cardiac Surgery Fellows Allograft Symposium
6. CryoLife to Present at 19th Annual Piper Jaffray Health Care Conference in New York
7. CryoLife to Present at OneMedPlace Finance Forum
8. CryoLife Announces Record Preservation Services and Product Revenues for 2007
9. CryoLife Responds to Inaccurate Assertions from Plaintiffs Attorney
10. Cryolife Once Again Severely Maims an Innocent Knee Surgery Patient
11. CryoLife Announces Release Date and Teleconference Call Details for the Fourth Quarter and Year End 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2017)... ... May 22, 2017 , ... Cancer diagnostics and pathology ... B2 at the Association for Pathology Informatics Annual Summit at the ... demonstrating its Cancer Diagnostic Cockpit and Consultation Portal, Inspirata will present research it ...
(Date:5/18/2017)... ... May 18, 2017 , ... Dr. Ralph ... at the Prince Of Wales Private Hospital. The procedure was performed on a ... patient failed conservative treatments prior to undergoing surgery. , The AxioMed viscoelastic disc ...
(Date:5/18/2017)... ... May 17, 2017 , ... Cognition ... and commercialization, has just released version 9.0 of the Cognition Cockpit platform. , ... of Cockpit,” says David Cronin, CEO of Cognition. “We’re thrilled to finally be ...
(Date:5/18/2017)... ... May 18, 2017 , ... When James Sherley, was notified earlier this year that his company ... the Year 2017 by The Silicon Review , he was not surprised as others ... Asymmetrex’s value, but this recognition by Silicon Valley was particularly meaningful. Our selection ...
Breaking Biology Technology:
(Date:4/11/2017)... -- Research and Markets has announced the addition of ... offering. ... market to grow at a CAGR of 30.37% during the period ... has been prepared based on an in-depth market analysis with inputs ... growth prospects over the coming years. The report also includes a ...
(Date:4/5/2017)... 5, 2017  The Allen Institute for Cell Science ... a one-of-a-kind portal and dynamic digital window into the ... the first application of deep learning to create predictive ... lines and a growing suite of powerful tools. The ... and future publicly available resources created and shared by ...
(Date:4/3/2017)...  Data captured by IsoCode, IsoPlexis Corporation,s ... statistically significant association between the potency of ... objective response of cancer patients post-treatment. The ... cancer patients will respond to CAR-T cell ... to improve both pre-infusion potency testing and cell ...
Breaking Biology News(10 mins):