Navigation Links
CryoLife Receives Humanitarian Use Device Designation for SynerGraft(R) Processed Human Aortic Heart Valves
Date:10/6/2009

ATLANTA, Oct. 6 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced that it has received a Humanitarian Use Device (HUD) designation from the Food and Drug Administration (FDA) for its CryoValve® SG aortic human heart valve. The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the CryoValve SG aortic human heart valve, which is processed with the Company's proprietary SynerGraft® technology. An approved HDE would allow the Company to market the CryoValve SG aortic human heart valve. The patented SynerGraft technology serves as the foundation for the next generation of implantable biological tissues and is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.

An HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States (U.S.) per year. An HUD can be granted when no comparable device with the same intended use is marketed through the premarket approval (PMA) process or the premarket notification (510(k)) process.

The CryoValve SG aortic human heart valve is intended to be used for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic aortic valves in children from 0 to 21 years of age. The Company estimates that up to 1,500 children per year could benefit from this technology if the Company is successful in obtaining an HDE, which is the next step in making these valves commercially available
'/>"/>

SOURCE CryoLife, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. CryoLife to Present at UBS Global Life Sciences Conference
2. CryoLife Announces First Clinical Use of BioFoam(R)
3. CryoLifes Second Annual Surgical Congress for the Ross Procedure to Draw More than 130 Cardiovascular Surgeons from Around the World
4. CryoLife Announces Implants of First FDA-Cleared SynerGraft(R) Processed Human Cardiac Patch Material
5. CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Cardiac Patch Material
6. CryoLife Reports Record First Quarter Revenues of $26.7 Million
7. CryoLife Announces Release Date and Teleconference Call Details for 2009 First Quarter Financial Results
8. CryoLife to Present at Sidotis 13th Annual New York Emerging Growth Institutional Forum
9. CryoLife Reports Record Annual Revenues of $105.1 Million for FY 2008
10. CryoLife Announces Release Date and Teleconference Call Details for 2008 Fourth Quarter and Year End Financial Results
11. CryoLife, Inc. Receives Tissue From 100,000th Donor, Marking Industry Milestone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)...   Niagara Thermal Products is proud to announce ... LLC ("B3") as the critical thermal component supplier in ... Army Corps of Engineers.  B3 has developed the only ... and destroys VOCs and other chemical pollutants, allergens and ...
(Date:1/15/2014)... Westlake Village, Calif. (PRWEB) January 15, 2014 ... cancer treatment and management through the genomic analysis of ... will offer Therapy Finder™, a web-based cancer decision support ... a reporting option with Cynvenio’s ClearID™ genomic test, Therapy ...
(Date:1/15/2014)... 15, 2014 ­ RedBrick Health , a fast-growing ... today announces that EmblemHealth , the ... is now providing the RedBrick Compass health assessment, combined ... all of its members. EmblemHealth is among the first ...
(Date:1/15/2014)... 15, 2014 A study has been launched ... Formula 1 track could help to tackle the problem of ... Stowhealth (a GP surgery based in Stowmarket) and academics at ... Telemetry technology, which is inspired by equipment used ...
Breaking Biology Technology:Niagara Thermal Products LLC Selected as Critical Supplier for Buffalo BioBlower Air Purification Systems 2Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 2Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 3EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 3Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 2Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 3Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 4
... International,Corporation (Nasdaq: PRXL ) announced today it ... Conference in New York, NY. James,Winschel, Senior Vice ... formal presentation on PAREXEL at 1:20 p.m. EST ... be available under the "Upcoming Events" section,on PAREXEL,s ...
... Inc. (Nasdaq: SVNT ) today announced the submission ... (FDA) seeking approval to,market pegloticase in the United States ... includes data from both the six-month,placebo controlled Phase 3 ... Extension (OLE) study. The data set includes 101 patients ...
... MEETING, Pa., Oct. 31 /Xinhua-PRNewswire-FirstCall/ -- BMP,Sunstone Corporation (Nasdaq: BJGP; ... present at the following conferences:, 1. ... in New York. Management is currently scheduled ... on Monday, November 3. A webcast of this presentation will ...
Cached Biology Technology:PAREXEL International to Present at Oppenheimer 19th Annual Healthcare Conference 2Savient Submits Biologics License Application (BLA) for pegloticase 2Savient Submits Biologics License Application (BLA) for pegloticase 3Savient Submits Biologics License Application (BLA) for pegloticase 4BMP Sunstone Announces Participation in November Investor Conferences 2
(Date:7/9/2014)... 2014) Emerging fungal pathogens pose a greater ... causing population declines of amphibians, bats, corals, bees ... South Florida published in the prestigious journal ... or immunological resistance to a deadly chytrid fungus ... "Acquired resistance is important because it is the ...
(Date:7/9/2014)... Researchers from The Cancer Genome Atlas (TCGA) Research ... cancer-causing pathway in lung adenocarcinoma, the most common ... changes may expand the number of possible therapeutic ... greater number of patients with treatable mutations because ... already exist. , TCGA is jointly funded and ...
(Date:7/9/2014)... may be able to cope with the rising salinity of ... Arctic today is best known for its tundra and polar ... to 38 million years ago during what is known as ... huge temperate forest with brackish water, home to a variety ... and giant tortoises. Much of what is known about the ...
Breaking Biology News(10 mins):USF study: Amphibians can acquire resistance to deadly fungus 2Study identifies novel genomic changes in the most common type of lung cancer 2Study identifies novel genomic changes in the most common type of lung cancer 3Shark teeth analysis provides detailed new look at Arctic climate change 2Shark teeth analysis provides detailed new look at Arctic climate change 3
... known already for its role in schizophrenia ... according to a report in todays advance on-line issue ... Deaconess Medical Center (BIDMC), the study further suggests that ... diagnostic marker and therapeutic supplement for the treatment of ...
... which glows under ultraviolet light have shown that up ... cleaned. Their findings, published in BioMed Centrals journal, BMC ... bacteria Clostridium difficile (C. difficile) linger in the loo ... Michelle Alfa and a team of scientists from Manitoba, ...
... technology, DALLAS, May 7 An innovator ... will provide its proven public key,infrastructure to the ... on machine readable travel documents (MRTDs),-- also known ... nearly 23 million,citizens by the end of 2008., ...
Cached Biology News:A new gene trigger for pregnancy disorder identified 2UV lotion lights the way to cleaner facilities 2Entrust, Hewlett Packard Partner to Deploy Taiwanese ePassports, Authenticate Biometric Data 2Entrust, Hewlett Packard Partner to Deploy Taiwanese ePassports, Authenticate Biometric Data 3
... Perhaps sheer in-house demand is causing shortages in ... antibody. This can cause unwanted distractions, problems and ... for your hard work and endeavour! Bring us ... and market it internationally. We work under ISO ...
... Neuromedin U-23 (rat) - Diluted Antiserum for ... Neuromedin U-23 (rat) Immunology Products, Host: ... For our corresponding peptide and ... please see Neuromedin U-23 (rat) (H-9295) and ...
... Topoisomerase I from vaccinia virus is ... both positive and negative superhelical turns (also ... closed DNA. The product of the reaction ... fewer positive or negative superhelical turns. DNA ...
...
Biology Products: