Navigation Links
HeartWare Receives Third Patient Allotment From FDA - Authorizing 94 Additional Patients - Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
Date:1/24/2011

FRAMINGHAM, Mass. and SYDNEY, Jan. 24, 2011 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a third allotment, of 94 additional patients, in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).  The FDA granted two prior allotments of 54 patients each in April and September 2010, and the final patient from the second cohort was implanted earlier this month.

HeartWare's ADVANCE clinical trial is an FDA approved IDE study designed to evaluate the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.  Under the ADVANCE study, 140 patients at 30 U.S. clinical sites received HeartWare HVAD® pumps, making it the largest bridge-to-transplant pivotal trial to date.  HeartWare submitted to the FDA a Pre-Market Approval (PMA) application seeking approval of the HeartWare System for the bridge-to-transplant indication in December 2010.

Patient enrollment under the third CAP can now commence at the 30 centers participating in the ADVANCE clinical trial, subject to Institutional Review Board approvals at these sites.  

About HeartWare InternationalHeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure.  The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implante
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. HeartWare to Present at the 29th Annual J.P. Morgan Healthcare Conference
2. HeartWare Files PMA Application for FDA Approval of the HeartWare® Ventricular Assist System for a Bridge-to-Transplant Indication
3. HeartWare International, Inc. Announces Completion of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
4. HeartWare International, Inc. Announces Pricing of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
5. HeartWare International, Inc. Announces Concurrent Public Offerings of Convertible Senior Notes and Common Stock
6. HeartWare to Present at the Canaccord Genuity Cardio/Diabetes & Obesity Conference
7. HeartWare Achieves Primary Endpoint with 92% Success in Pivotal Bridge-to-Transplant Clinical Trial, ADVANCE
8. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
9. HeartWare Bridge-to-Transplant Data Featured as Late Breaking Clinical Trial at American Heart Association Scientific Sessions 2010
10. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
11. HeartWare to Report Financial Results for Third Quarter of 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)...  A substantial share of pharmacy and therapeutics ... are included in formularies—say patient support resources from ... Manhattan Research study, Taking the Pulse® Formulary ... P&T committee members in hospitals, managed care organizations ... a high bar for these programs, requiring that ...
(Date:7/31/2014)... Lazarus Effect, a medical device company focused ... removal of blood clots, announced the closing of a ... EU commercialization of several approved Lazarus Effect devices, as ... Lazarus Cover™ in the United States ... the value of our novel, platform technology as well ...
(Date:7/31/2014)... , July 31, 2014 For its innovative ... California , Art,s-Way Scientific has earned a Modular ... With competition in over 30 categories, MBI,s contest is ... members, which include building manufacturers, dealers, and product and ... excellent example the capability of our team," said ...
Breaking Medicine Technology:Formulary Decision Makers Say Pharma-Provided Patient Support Solutions Influence Formulary Placement 2Formulary Decision Makers Say Pharma-Provided Patient Support Solutions Influence Formulary Placement 3Lazarus Effect Closes $5 Million Financing 2Art's Way Scientific Earns Prestigious Modular Building Institute Award 2Art's Way Scientific Earns Prestigious Modular Building Institute Award 3Art's Way Scientific Earns Prestigious Modular Building Institute Award 4
... , SAN MATEO, Calif., Oct. 1 Corthera Inc. ... (FDA) has granted Fast Track designation to relaxin, the ... failure (AHF). The Fast Track program facilitates the development ... treat serious or life-threatening conditions and that demonstrate the ...
... Oct. 1 Health Strategies Group, a leading ... industries, has just launched Oncology Performance Edge, a new ... in the oncology field improve brand performance by understanding ... oncology market is significantly different from others, with unique ...
Cached Medicine Technology:Corthera's Relaxin Receives FDA Fast Track Designation for the Treatment of Acute Heart Failure 2Corthera's Relaxin Receives FDA Fast Track Designation for the Treatment of Acute Heart Failure 3Health Strategies Group Introduces Oncology Performance Edge 2Health Strategies Group Introduces Oncology Performance Edge 3
(Date:7/31/2014)... United Theological Seminary is pleased to welcome two ... Peter J. Bellini. Both began their teaching duties on ... Director of Non-Degree Programs, Mark Abbott, who begins his ... Assistant Professor of New Testament, received a Ph.D. from ... Temple Judaism, and Greek courses. His research interests are ...
(Date:7/31/2014)... July 31, 2014 Cosmetic Town is ... Plastic Surgeons to consumers considering cosmetic treatments. The ... peers whose goal is to educate prospective patients on ... selected through a validated referral system that helps patients ... best in their respective fields. , Cosmetic Town ...
(Date:7/31/2014)... The VitaSleep FDA cleared anti-snoring ... provide an easier breathing capacity by slightly adjusting the ... people can breathe easier and helps reduce or even ... that it can meet the needs of each individual ... shared by actual customer reviews. Johathan R. from ...
(Date:7/31/2014)... Miami, FL (PRWEB) July 31, 2014 ... (LMS) which continues to help healthcare agencies to ... help companies and agencies meet their accreditation ... with competency based training. , Healthcare administrators ... a few clicks of the mouse. Courses can ...
(Date:7/31/2014)... Andrie, Inc. V. Dept. of Treasury, Mich. S. Ct., ... made the determination that a purchaser of tangible goods in ... unable to prove during an audit that sales tax ... of Appeals decision on whether a purchaser bears the burden ... from Michigan sellers. The Court states “in order to be ...
Breaking Medicine News(10 mins):Health News:Growing Seminary Welcomes New Faculty 2Health News:The New Doctors’ Directory, Cosmetic Town Does the Research for Consumers of Plastic Surgeries 2Health News:New Dental Device Reviews to Stop Snoring by VitalSleep 2Health News:Company Helps Healthcare Agencies to Pass Inspections and Audits 2Health News:Company Helps Healthcare Agencies to Pass Inspections and Audits 3Health News:Taxpayer Failing To Prove Sales Tax Was Paid At Time Of Purchase Results In Use Tax Due 2Health News:Taxpayer Failing To Prove Sales Tax Was Paid At Time Of Purchase Results In Use Tax Due 3
... group of scientists, led by mathematicians, has taken on ... responses. Their work will radically improve our understanding of ... disciplines working on it to have a common reference ... and Biological Sciences Research Council (BBSRC), will investigate how ...
... Researchers have identified which sites and cell types ... avian influenza viruses, providing valuable insights into the pathogenesis ... et al, Human and avian influenza viruses target different ... other mammals, appears in the October issue of The ...
... Grants Initiative to Support Hundreds of Research Projects ... Involving Scientists Around the World, ... Melinda,Gates Foundation announced today that it is committing $100 million ... support,innovative global health research. The initiative,s goal is to encourage,scientists ...
... Oct. 9 Medical Simulation Corporation (MSC) ... with the Methodist DeBakey Heart,Center in Houston ... help Methodist cardiologists and surgeons improve patient,safety ... update surgical and,interventional skills in a simulated, ...
... Available at ... PhillyHealthInfo.org, PHILADELPHIA, Oct. 9 PhillyHealthInfo is the ... Chester,Delaware, and Montgomery counties. Go to http://www.PhillyHealthInfo.org ,for this season,s flu ... Where to go for free or low cost flu shots. -- ...
... Experiences and sanofi-aventis, Goal to be Part of ... Among Stakeholders, LITTLE ROCK, Ark., Oct. 9 ... at the Collaborative Practice Summit (CPS) hosted by the ... in Uncasville,Conn. CPS brought together a focused group ...
Cached Medicine News:Health News:Mathematicians help unlock secrets of the immune system 2Health News:Influenza: Insights into cell specificity of human vs. avian viruses 2Health News:Gates Foundation Launches $100 Million Initiative to Spur Innovation in Global Health Research 2Health News:Gates Foundation Launches $100 Million Initiative to Spur Innovation in Global Health Research 3Health News:Medical Simulation Corporation Announces Partnership with Methodist DeBakey Heart Center in Houston 2Health News:Sanofi-aventis US Chairman Tim Rothwell Addresses CMSA's Collaborative Practice Summit 2Health News:Sanofi-aventis US Chairman Tim Rothwell Addresses CMSA's Collaborative Practice Summit 3Health News:Sanofi-aventis US Chairman Tim Rothwell Addresses CMSA's Collaborative Practice Summit 4
The adult blanket provides full coverage for patients of all sizes. The generous size and versatility of these blankets include extra material for the shoulders and feet. The foot drape also reduces ...
The cath lab blanket, designed for use in the Cardiac Cath Lab, surrounds the patient with warm air and allows unrestricted access to the femoral artery....
The Bair Hugger outpatient blanket makes it easy to give your patients the benefit of prewarming and enhance patient comfort during outpatient procedures....
The fabric is antistatic and non-linting and is both oil and water repellent.These superior blankets are an environmental friendly alternative to disposable blankets....
Medicine Products: