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

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 implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.  HeartWare has received CE Marking for the HeartWare System in the European Union.  The device is currently the subject of United States clinical trials for two indications: bridge-to-transplant under a continued access protocol and destination therapy.  For additional information, please visit

HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.

Forward-Looking StatementsThis announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management.  All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the progress of, and presentation of data related to, clinical trials, expected timing of FDA regulatory filings, FDA acceptance of our filings and research and development activities. Management believes that these forward-looking statements are reasonable as and when made.  However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made.  HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.  Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility the FDA does not accept our PMA application or approve the marketing of the HeartWare® Ventricular Assist System in the U.S., and those described in "Item 1A. Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission.  We may update our risk factors from time to time in "Part II, Item 1A "Risk Factors" in our Quarterly Reports on Form 10-Q, or other current reports, as filed with the Securities and Exchange Commission.For further information:Christopher TaylorHeartWare International, Inc.Email: ctaylor@heartwareinc.comPhone: +1 508 739 0864

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

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:
(Date:11/25/2015)... 2015 Developmental, commercial, and regulatory/legal ... profitability of pharmaceutical products, says GBI Research ... regulatory/legal strategies all play a key role in boosting ... . --> Developmental, commercial, ... in boosting the profitability of pharmaceutical products, says ...
(Date:11/24/2015)... NEW DELHI , November 25, 2015 ... fear invoked due to repeated failure of IVF cycles. ... Rani Bhatia was totally dejected and had lost all hopes that ... the first Indian miracle child conceived after failure of ... to abroad (UK) before they decided to take one last ...
(Date:11/24/2015)... HILL, N.C. , Nov. 24, 2015  In ... research projects in an effort to quickly uncover new ... position. --> --> ... launch a market research project and ensure that all ... company and industry standards. Another major barrier to efficiently ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... In an ongoing Clinical Study conducted by an independent ... UV Angel is evaluating the efficacy of its product and its disinfection protocol. This ... beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic medical center ...
(Date:11/25/2015)... ... November 25, 2015 , ... "When I underwent breast reconstruction ... incredibly uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my ... RECOVERY BRA for added comfort and support. The bra is easier to put ...
(Date:11/25/2015)... ... ... Since its launch in 2012, the Regenestem brand ( ... to patients with chronic degenerative medical conditions. Now, the U.S. Patent and Trademark ... Organizations are required to hold a registered trademark in order to make licensing ...
(Date:11/24/2015)... ... ... Dr. Todd S. Afferica, a noted general dentist in Norcross, GA ... Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental procedures. ... traditional cutting tools, such as the scalpel and high-speed drill, which can both cause ...
(Date:11/24/2015)... ... , ... In an article published November 12th by Obesity News ... or are not eligible for bariatric surgery. The article explains that candidates for weight ... 100 pounds overweight, or have a BMI of 35 and over with at least ...
Breaking Medicine News(10 mins):