Navigation Links
HeartWare International Surpasses 50 Implants in the US
Date:8/20/2009

FRAMINGHAM, Mass. and SYDNEY, Aug. 20 /PRNewswire-FirstCall/ -- HeartWare International, Inc. (Nasdaq: HTWR - ASX: HIN) today announced that HeartWare has surpassed 50 implants in the United States under its ADVANCE Clinical Trial, marking an important early enrollment milestone.

The 50th implant in the US was performed last week at the Texas Heart Institute in Houston, Texas by O.H. Frazier, MD a distinguished surgeon, scientist, and academician renowned for his research and development of new cardiovascular surgical techniques and ventricular assist devices. "We are very pleased with the early clinical results of this small pump. Its unique inflow cannula and small size enable us to place the device without a surgical pump pocket, which greatly reduces the risk of serious infection. The improved pump simplifies implantation and allows for optimal function, even in difficult cases where the myocardium is thin or the apex of the ventricle is difficult to access," said Dr. Frazier.

HeartWare's ADVANCE Clinical Trial is an FDA approved IDE study designed to evaluate the HeartWare((R))( )Ventricular Assist system as a bridge to heart transplantation for patients with end-stage heart failure. The primary endpoint of the trial is survival at 180-days post surgical implantation. Under the IDE, a total of 150 patients will be enrolled across a maximum of 28 centers. Currently, 16 centers are enrolling patients. HeartWare expects the number of active centers to expand steadily over coming months as the balance of the 28 sites work through the steps required to begin enrolling patients.

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 US 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((R)) 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((R)) 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                           US Investor Relations
    Howard Leibman                              Matt Clawson
    HeartWare International                     Allen & Caron, Inc
    Email. howard.leibman@heartware.com.au      Email. matt@allencaron.com
    Tel.  +61 402 440 644                       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, 2008, and those described in other reports filed from time to time with the SEC.


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

Related medicine news :

1. HeartWare Selects Allen & Caron for Investor Relations and Corporate Communications
2. HeartWare Announces Move to an Expanded, Upgraded Manufacturing Facility
3. HeartWare Receives Conditional Approval of IDE
4. HeartWare to Present at Seventh Annual JMP Securities Research Conference
5. Thoratec Announces Definitive Agreement to Acquire HeartWare International For US$282 Million;
6. Thoratec and HeartWare Receive Request for Additional Information From Federal Trade Commission
7. HeartWare to Present at Eighth Annual JMP Securities Research Conference
8. HeartWare to Webcast Annual Meeting
9. Thoratec Corporation and HeartWare International, Inc. Announce Termination of Proposed Transaction
10. HeartWare International, Inc. Announces US$55 Million Financing
11. HeartWare to Present at Canaccord Adams 29th Annual Global Growth Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/18/2019)... (PRWEB) , ... July 18, 2019 , ... Gateway ... future children, announces a new publication titled, “ Accurate Fetal Sex Determination from Maternal ... Birth. In the study, DNA blood samples were collected from 108 women at an ...
(Date:7/17/2019)... ... July 17, 2019 , ... Dynamic Healthcare Systems, ... Advantage, Medicaid, and Marketplace programs is pleased to announce the introduction of an ... (EHR) integration at the point of care to providers and provider groups ...
(Date:7/17/2019)... ... July 17, 2019 , ... This past Saturday, Monarch Dental® ... Foundation . Over 50 underserved patients were welcomed at the Mesquite office to receive ... the summer season. Individuals were referred to the event through local nonprofit organizations such ...
(Date:7/17/2019)... LAPEER, Mich. (PRWEB) , ... July 17, 2019 , ... Women’s Excellence is pleased to ... later this summer in September. The new offices resides on the corner of Turrill ... we listened! We are thrilled about the opening of our new office in Lapeer ...
(Date:7/13/2019)... ... July 12, 2019 , ... Ospitek Inc., a ... patient management platform, Ospitek “View”. Ospitek has partnered with some of the country’s ... customizable, intelligent, solution made specifically for surgical centers, allowing them to directly engage ...
Breaking Medicine News(10 mins):
(Date:7/19/2019)... ... , ... Cloudticity, a pioneer in providing HIPAA-compliant cloud solutions, ... of Business Development. , Whaley will work with healthcare organizations on finding ... a technology leader with more than 20 years of experience, he’ll also strengthen ...
(Date:7/19/2019)... ... July 19, 2019 , ... Robinson Pharma, Inc., is ... that the facilities was audited by the Safe Quality Food (SQF) Institute using an ... SQF Food Safety Code for Manufacturing, Edition 8. , The SQF Certification program is ...
(Date:7/18/2019)... ... 2019 , ... ComplianceLine, the premier provider of whistleblower hotline, ... is moving into new corporate headquarters in Charlotte to service accelerating growth in ... into the new office which will allow our expanding team of compliance professionals ...
Breaking Medicine Technology: