Navigation Links
U.S. FDA Authorizes Expansion to 40 Clinical Sites for HeartWare U.S. Bridge-to-Transplant Clinical Trial
Date:10/5/2009

FRAMINGHAM, Mass. and SYDNEY, Oct. 5 /PRNewswire-FirstCall/ -- HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to expand the number of clinical sites participating in its U.S. bridge-to-transplant trial, known as the ADVANCE trial. Pursuant to the FDA approval, HeartWare will be permitted to enroll a total of 40 clinical sites for the purposes of evaluating the Company's Ventricular Assist System (HVAD) in end-stage heart failure patients requiring circulatory support to bridge them to a heart transplant.

"We continue to be encouraged by the number of physicians who believe the HVAD may provide an important benefit for their patients and we hope that the enthusiasm for our system continues to grow as their experience expands," said Doug Godshall, President and CEO of HeartWare.

"While we have had strong interest from high caliber transplant centers that want to join our ADVANCE trial, we could not previously accommodate them due to our existing 28 clinical site limitation. Receipt of FDA approval enabling expansion from 28 to 40 clinical sites allows us to accept many of these additional sites prior to the completion of enrolment which we project will occur in the first half of 2010," continued Godshall.

At present, HeartWare currently has 22 clinical sites initiated in the United Sites with 69 patients implanted in the 150 patient study.

About End Stage Heart Failure

Heart failure is one of the leading causes of death in the developed world. According to the American Heart Association, congestive heart failure (CHF) afflicts approximately 5 million people in the U.S. with approximately 550,000 new cases diagnosed each year. Despite new treatment strategies for patients with end-stage heart failure, the number of patients who die with this disease is of epidemic proportion. Cardiac transplantation is currently the most effective therapy for the treatment of advanced end stage heart failure, however, its application is limited due to the lack of available donor organs.

Over the last decade, bridging to cardiac transplantation with implantable left ventricular assist devices (LVADs) has gained wider clinical acceptance and LVADs are used to extend life expectancy for patients with end-stage heart failure who might otherwise deteriorate while awaiting a donor heart.

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or left ventricular assist devices, to treat Class IIIb and Class IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD(TM) 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® Ventricular Assist System in the European Union. The device is currently the subject of a 150-patient clinical trial in the United States for a Bridge-to-Transplant indication.

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

    For further information:

    www.heartware.com
    HeartWare International, Inc.
    David McIntyre - Chief Financial Officer & Chief Operating Officer
    Email: dmcintyre@heartwareinc.com
    Tel:  +1 305 818 4100

    US Investor Relations
    Matt Clawson
    Allen & Caron Inc
    Email: matt@allencaron.com
    Tel:  +1 949 474 4300

Forward-Looking Statements

This 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 clinical trials. 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. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We 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 those described in "Item 1A. Risk Factors" in our Annual Report on Form 10-K filed with the SEC on February 28, 2009, and those described in other reports filed from time to time with the SEC.

SOURCE HeartWare International, Inc.


'/>"/>
SOURCE HeartWare International, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
2. Alseres Pharmaceuticals Announces Expansion of the Cethrin(R) Acute Spinal Cord Injury (SCI) Phase I/IIA Clinical Trial
3. On Second Anniversary, Compendia Bioscience Announces Significant Revenue Growth, Completion of Product Milestone and Expansion of Pharma Customer Commitments
4. CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Melanoma
5. Potentia Pharmaceuticals Announces Positive Safety Data and Study Expansion in Phase I Trial for Lead Drug Candidate POT-4
6. CEL-SCI Announces Expansion of Exclusive Licensing Agreement for Cancer Drug Multikine
7. Delcath Continues Expansion of Clinical Trial Centers Offering PHP(TM)
8. CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer
9. Health Robotics CytoCare(TM) Global Expansion Continues With Grifols International in Latin America
10. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
11. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016  In a startling report released today, ... their residents by lacking a comprehensive, proven plan to eliminate prescription ... definitive ranking of how states are tackling the worst drug crisis ... four states – Kentucky , New ... Vermont . Of the 28 failing states, three – ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are ... Code Talker Award, an essay contest in which patients and their families pay tribute ... presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... is proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon ... beautiful women in the world, and the most handsome men, look naturally attractive. ...
(Date:6/24/2016)... ... 2016 , ... Strategic Capital Partners, LLC (SCP) in concert ... capital for emerging technology companies. SCP has delivered investment events and professional ... than a million dollars of capital investment for five companies. The ...
Breaking Medicine News(10 mins):