Navigation Links
CryoLife Initiates Enrollment in U.S. Clinical Trial for BioFoam®
Date:10/24/2011

ATLANTA, Oct. 24, 2011 /PRNewswire/ -- CryoLife, Inc., (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology.  In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.

The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.  

"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. "We have worked with FDA on two recent protocol amendments which we think should help speed enrollment into the pilot study. Once it is completed, assuming that the data is positive, we will begin planning for a larger pivotal study to support a PMA application for BioFoam with the FDA. We believe that BioFoam may hold promise for surgeons around the world and are encouraged by the early clinical experience in Europe."

Upon successful completion of the feasibility study in the U.S., and subsequent FDA and Department of Defense approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study is planned.  It is currently antici
'/>"/>

SOURCE CryoLife, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. CryoLife Announces First Implant of Combination Aortic-Mitral Allograft Heart Valve at the Cleveland Clinic
2. CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)
3. CryoLife Reports Record Quarterly Revenues of $28.2 Million
4. CryoLife to Present at Upcoming Investor Conferences in New York
5. CryoLife to Present at 21st Annual Piper Jaffray Health Care Conference
6. CryoLife Provides Initial 2010 Financial Guidance
7. CryoLife Enters into Worldwide Distribution and Manufacturing Agreements with Starch Medical for Novel Hemostatic Agent
8. CryoLife Receives Japanese Regulatory Approval for BioGlue Surgical Adhesive
9. CryoLife Announces Release Date and Teleconference Call Details for 2010 Third Quarter Financial Results
10. CryoLife Begins Distribution of Blood-Clotting Agent PerClot® in Europe
11. CryoLife to Present at Lazard Capital Markets 7th Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/22/2014)... July 22, 2014  Edwards Lifesciences Corporation (NYSE: ... of heart valves and hemodynamic monitoring, announced that Edwards, ... served as an expert panelist at the invitation of ... Health to discuss medical device innovation at its hearing, ... Evidence Development and Communication." "Edwards has five ...
(Date:7/22/2014)... 22, 2014  Jazz Pharmaceuticals plc (Nasdaq: ... 2014 second quarter financial results on Tuesday, August 5, ... management will host a live audio webcast immediately following ... provide a business and financial update and discuss second ... access the live audio webcast via the Investors & ...
(Date:7/22/2014)... Research and Markets has announced the addition ... Reagent, by Application - Global Forecast to 2018" ... http://photos.prnewswire.com/prnh/20130307/600769 Biopharmaceuticals are pharmaceutical products isolated ... most important and widely used techniques for biopharmaceutical production. ... cell culture market in 2013. Growth in the biopharmaceutical ...
Breaking Medicine Technology:Edwards' CEO Invited To Address Congress On Opportunities To Revitalize Medical Device Innovation 2Jazz Pharmaceuticals to Report 2014 Second Quarter Financial Results on August 5, 2014 2Global Cell Culture (Bioreactor, Incubator, Centrifuge) Market - Forecast to 2018 2Global Cell Culture (Bioreactor, Incubator, Centrifuge) Market - Forecast to 2018 3
... ) announced today that its Board of Directors approved a regular cash dividend payment of $0.0425 per share. , ... , , ... ... The dividend is payable on May 7, 2010 to shareholders of record as of April 6, 2010 . , ...
... ... , ... ... SILVER SPRING, Md. , March 22 FDA is recommending that healthcare practitioners temporarily suspend use of ...
Cached Medicine Technology:Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk 2Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk 3Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk 4
(Date:7/22/2014)... Steven Reinberg HealthDay Reporter ... are obese during pregnancy may be more likely to have ... "We found that, compared with children born from mothers ... during pregnancy had up to 20 to 30 percent higher ... assistant professor of pediatrics at Children,s Hospital of Pittsburgh. ...
(Date:7/22/2014)... (WASHINGTON, July 22, 2014) The American Society of ... Vanderbilt University School of Medicine, and Robert P. Hebbel, ... the 2014 Ernest Beutler Lecture and Prize for their ... disease. , The Ernest Beutler Lecture, named for the ... and physician-scientist for more than 50 years, is a ...
(Date:7/22/2014)... a member of the Clean Plate Club you eat ... not alone! A new Cornell University study shows that ... puts on his or her plate. "If you ... says Brian Wansink Ph.D., author of the forthcoming book, Slim ... Food and Brand Lab. , Wansink and co-author Katherine Abowd ...
(Date:7/22/2014)... Dr. Ross Feldman says women are often in the dark. ... disease, however, data has shown that post-menopausal women are just ... less likely to be adequately diagnosed and treated. New research ... British Journal of Clinical Pharmacology brings to light a ... identify which women are more prone to heart disease. , ...
(Date:7/22/2014)... D.C. (PRWEB) July 22, 2014 ... “Ensuring Seniors Access to Local Pharmacies Act of ... Medicare Part D would undermine the availability of ... spending by $21 billion over the next 10 ... Company released by the Pharmaceutical Care Management Association ...
Breaking Medicine News(10 mins):Health News:Obesity During Pregnancy Linked to Raised Asthma Risk in Kids 2Health News:Obesity During Pregnancy Linked to Raised Asthma Risk in Kids 3Health News:Michael DeBaun, M.D., M.P.H., and Robert P. Hebbel, M.D., to present 2014 ASH Beutler Lecture 2Health News:Michael DeBaun, M.D., M.P.H., and Robert P. Hebbel, M.D., to present 2014 ASH Beutler Lecture 3Health News:Michael DeBaun, M.D., M.P.H., and Robert P. Hebbel, M.D., to present 2014 ASH Beutler Lecture 4Health News:Gene variant identified as a heart disease risk factor for women 2Health News:PCMA: New Study Finds H.R. 4577 to Cost $21 Billion Over 10 Years 2
... LONDON, November 11 Extensive research conducted by the,Imperial ... on the Simbionix PROcedure Rehearsal Studio(TM), was awarded a,Magna ... in Lisbon, Portugal. , The ... world,s first patient specific system to enable clinicians to ...
... ... the home or office using methods and products that are government-approved, but that won,t harm ... ... present The Natural Flu Protection Kit, the first product to emerge from the company’s partnership ...
... ... , ... November 11, 2009 -- HEALTHeCAREERS , North America’s premier healthcare Network, is advertising ... the medical industry continues to be one of the few bright spots in the ...
... ... and the Beyond the Box team can assist seniors and their loved ones with the ... ... relocation and design firm, Beyond the Box , is pleased to announce its new ...
... The following statement can be attributed to Steven ... the American Chemistry Council (ACC) regarding the study published ... the Risk of Self-Reported Male Sexual Dysfunction," by D. ... study of occupational exposure to bisphenol A (BPA) among ...
... School of Public Health researchers will present Nov. 11 ... Health Association,s annual meeting in Philadelphia, including a study ... large-scale worksite wellness program. Additional public health ... Does faith affect how Southern African-American women use ...
Cached Medicine News:Health News:Research on Simbionix PROcedure Rehearsal Software Awarded Magna Cum Laude Prize at CIRSE 2009 2Health News:Research on Simbionix PROcedure Rehearsal Software Awarded Magna Cum Laude Prize at CIRSE 2009 3Health News:Green Living Expert Annie B. Bond's Natural Flu Protection Kit 2Health News:Green Living Expert Annie B. Bond's Natural Flu Protection Kit 3Health News:Healthcare Web Site Boasts Thousands of Jobs in a Down Economy 2Health News:Relocation Specialists Beyond the Box Team With Nurse to Help Facilitate Senior Moves 2Health News:Relocation Specialists Beyond the Box Team With Nurse to Help Facilitate Senior Moves 3Health News:Findings from New Study on Occupational Exposure to BPA of Limited Relevance to Consumers 2Health News:Worksite wellness programs may reduce employee absenteeism 2
Micro suture forceps....
Mini blades....
... M520 OH3 is a smart ... performance available on the market ... stand. The Leica M520 OH3 ... greatest range of movement and ...
Operating microscope with motorized zoom and variable focus up to 405 mm....
Medicine Products: