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

r 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
'/>"/>

SOURCE CryoLife, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

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:9/17/2014)... , Sept. 17, 2014 The global consumption of ... 2019. Squalene is a natural skin-identical chemical that finds applications ... care, food supplements, pharmaceuticals, and in other applications like high ... market has a few major players and is regionally segregated. ... Special Liver Oil Co. Ltd. ( Japan ), ...
(Date:9/17/2014)... TRIANGLE PARK, N.C. , Sept. 17, 2014 /PRNewswire/ ... and presentation topics that will be featured at the ... Hamner Conference Center on December 3 and 4, 2014. ... managers are invited to hear the following: ... PhD UC San Diego Skaggs School of ...
(Date:9/17/2014)... (PRWEB) September 17, 2014 ... Two-Dimensional Liquid Chromatograph (2D-LC), which offers a ... sample matrices. The system provides a new ... analytes, which is beneficial to scientists analyzing ... and natural products. , Comprehensive 2D-LC combines ...
(Date:9/17/2014)... 2014 A biodegradable polymer can ... as bacteria, fungi, and algae into smaller units ... inorganic compounds, carbon dioxide, and humus in a ... and improved costs, biodegradable polymers are proving to ... to conventional polymers. Primary factors that are responsible ...
Breaking Biology Technology:Squalene Market by Source (Animal & Vegetable) & by End-user Industry (Cosmetics, Pharmaceuticals & Food Industry) - Global Trends & Forecasts to 2019 2Squalene Market by Source (Animal & Vegetable) & by End-user Industry (Cosmetics, Pharmaceuticals & Food Industry) - Global Trends & Forecasts to 2019 3In Silico Drug Discovery Conference Announces Speakers and Topics 2In Silico Drug Discovery Conference Announces Speakers and Topics 3In Silico Drug Discovery Conference Announces Speakers and Topics 4In Silico Drug Discovery Conference Announces Speakers and Topics 5In Silico Drug Discovery Conference Announces Speakers and Topics 6In Silico Drug Discovery Conference Announces Speakers and Topics 7Shimadzu’s New Nexera-e Two Dimensional Comprehensive Liquid Chromatograph Empowers Laboratories to Separate Even the Most Complex Mixtures 2Growing Demand for Eco-Friendly Products Drives the Global Biodegradable Polymers Market, According to New Report by Global Industry Analysts, Inc. 2Growing Demand for Eco-Friendly Products Drives the Global Biodegradable Polymers Market, According to New Report by Global Industry Analysts, Inc. 3
... DENVER, Nov. 8, 2011 Quest Diagnostics joined the ... participate in the American Cancer Society,s historic Cancer Prevention ... this national, longitudinal study is between November 8 and ... lifestyle, environmental and genetic factors that influence cancer risk ...
... VIENNA, November 8, 2011 Santo VC ... AFFiRiS AG   effective immediately and has also secured an ... same time, the German MIG fund increased its existing investment ... fund. As a result, AFFiRiS now has an additional EUR ...
... Biotech, Inc. (a suburban Philadelphia-based Company) announced today, at ... brand name of its flagship product to "RENADYL™." Formerly ... probiotic formulation helps maintain healthy kidney function. At a ... and health benefits of probiotics, Kibow has opted for ...
Cached Biology Technology:Quest Diagnostics Encourages Denver Area Residents to Enroll in Historic American Cancer Society Prevention Study November 8th - 19th 2Quest Diagnostics Encourages Denver Area Residents to Enroll in Historic American Cancer Society Prevention Study November 8th - 19th 3AFFiRiS AG: Capital Increase: AFFiRiS Brings Santo VC and MIG 11 on Board 2AFFiRiS AG: Capital Increase: AFFiRiS Brings Santo VC and MIG 11 on Board 3AFFiRiS AG: Capital Increase: AFFiRiS Brings Santo VC and MIG 11 on Board 4Kibow Changes Name of Flagship Kidney Function Support Product to 'RENADYL™' 2
(Date:9/16/2014)... on September 13, 2014. The fire is human-caused and ... 2,300 acres in size and is mostly being fueled ... calm Monday night due to higher humidity. Yesterday ... beginning to construct a fireline on the West and North ... on the fire: , 7 20-person Crews, 4 Hot Shot ...
(Date:9/16/2014)... of rock hit the Yukatan peninsula near the site of ... teratons of TNT. It left a crater more than 150 ... volcanism are widely accepted to have wiped out the dinosaurs ... what happened to the plants on which the dinosaurs fed? ... of Arizona reveals that the meteorite impact that spelled doom ...
(Date:9/16/2014)... votes for independence later this week, its Government could ... that fracking is necessary, research has revealed. , The ... public perception of shale gas extraction in the UK ... north of the border are the least supportive of ... in the University,s School of Geography, said: "The clear ...
Breaking Biology News(10 mins):Meteorite that doomed the dinosaurs helped the forests bloom 2Meteorite that doomed the dinosaurs helped the forests bloom 3Scottish people most sceptical on fracking, survey shows 2Scottish people most sceptical on fracking, survey shows 3
... in their own interests and do not cooperate ... severity of infection. The selfish behaviour ... treat antibiotic-resistant infections, according to research being presented ... today. Bacteria work together by using a ...
... TORONTO, ON - Widespread reports of a decline in the ... and speculation that pollination is also likely on the decline. ... long-term evidence of a downward trend in pollination, while also ... numbers may have declined at our research site, but we ...
... San Diego have discovered that a gene critical for programmed ... stem cells, a finding that could help to improve the ... chemotherapy or radiation therapy that kills cancer cells by inducing ... side effects for human cancer patients is the depletion of ...
Cached Biology News:Backstabbing bacteria: A new treatment for infection? 2Biologists find way to reduce stem cell loss during cancer treatment 2
... Cell Lines ,High Quality, Functionally-Validated, Ion Channel ... known for having a critical role in ... a key function in pain, CNS and ... have been investigated in therapeutic areas, such ...
... PrecisION Ion Channel Cell Lines ,High ... ,Ion channels are well known for having ... function and consequently have a key function ... that modulate ion channels have been investigated ...
... PrecisION Ion Channel Cell Lines ,High ... ,Ion channels are well known for having ... function and consequently have a key function ... that modulate ion channels have been investigated ...
Mouse polyclonal antibody raised against a partial recombinant CD320. NCBI Entrez Gene ID = 51293...
Biology Products: