Navigation Links
Presentation of HeartWare Clinical Results
Date:4/15/2008

Survival Rate of 91% Among First 23 Patients

FRAMINGHAM, Mass., SYDNEY, Australia, April 15 /PRNewswire-FirstCall/ -- HeartWare Limited (ASX: HTW), a developer of miniaturized implantable heart pumps to treat advanced heart failure, today announced initial results from an international clinical trial of the HeartWare(R) Left Ventricular Assist System. The results were presented by Dr. Georg Wieselthaler, cardiothoracic surgeon at Vienna General Hospital, at the annual meeting of the International Society for Heart and Lung Transplantation held in Boston.

The data presented by Dr Wieselthaler show a six-month survival rate of 91 percent among the first 23 patients implanted with the HeartWare device. Of the 23 patients, 21 patients met the primary endpoint of the trial, defined as survival to 180 days or transplantation. These included 19 patients who were supported by the HeartWare system at 180 days and two patients who received transplants, after 157 days and 176 days respectively.

Dr. Wieselthaler noted that one of the key features of the pump is its small size, which allows it to be implanted in the chest, thereby avoiding the abdominal surgery generally required to implant competing devices.

HeartWare CEO Mr. Douglas Godshall said the early clinical success of the HeartWare pump is a key outcome for the Company as it accelerates its efforts to make the device available to patients in the United States and around the world.

"These results are very promising," Mr. Godshall said. "Our early data appears to validate the benefits we believe to be inherent in the design of our device -- namely its small size, pericardial placement and wearless mechanism. These results give us great confidence as we move towards the start of our U.S. clinical trial and towards commercial release of the product in Europe."

To date a total of 32 patients have been enrolled in HeartWare's international clinical trial. The average duration of support across this patient group exceeds 220 days per patient. The cumulative period of support across the group exceeds 7,000 days or approximately 19 years. Eight of the patients have been supported by the HeartWare system for periods exceeding 12 months, including one patient who has been supported for more than 500 days.

HeartWare plans to commence a U.S. trial in the middle of 2008. In the U.S. alone more than 5 million patients suffer from heart failure and fewer than 3,000 donor hearts become available each year.

About HeartWare

HeartWare develops and manufactures miniaturized implantable heart pumps, or Left Ventricular Assist Devices (LVADs), designed to treat patients suffering from advanced heart failure. The Company is developing the industry's smallest and least invasive pumps, which it believes will be the key to unlocking the potential of a large and underserved market. The HeartWare(R) LVAD is a full-output pump designed to be implanted in the chest, avoiding the abdominal surgery generally required to implant competing devices. The device is currently the subject of an international clinical trial involving five investigational centres in Europe and Australia.

For further information:

http://www.heartware.com.au US Investor Relations

Howard Leibman Matt Clawson

Director Corporate Development Partner

HeartWare Limited Allen & Caron, Inc.

Email. howard.leibman@heartware.com.au Email. matt@allencaron.com

Tel. +61 2 9238 2064 Tel. +1 949 474 4300


'/>"/>
SOURCE HeartWare Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
2. Iomai Announces Data from Phase 2 Field Study of Travelers Diarrhea Vaccine Accepted for Presentation at ICAAC
3. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
4. Threshold to Host Conference Call to Discuss Results From Clinical Presentations at European Cancer Conference (ECCO)
5. Telik Announces Presentation of Preclinical Data on Dual Inhibitors of Aurora Kinases and VEGFR2
6. Spectrum Pharmaceuticals Announces Presentation of SPI-1620 Data at the AACR-NCI-EORTC International Conference
7. CuraGen Announces Presentation of Phase I Dose-Escalation Results on CR011- vcMMAE for Metastatic Melanoma
8. CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference
9. IDM Pharma Announces Upcoming Clinical Data Presentations
10. Access Pharmaceuticals Announces Two Poster Presentations Reporting Significant Preclinical Data on ProLindac(TM) at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference
11. Schering-Plough Highlights PEGINTRON(TM) Clinical Data Presentations at the American Association for the Study of Liver Diseases (AASLD) 2007 Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... , May 3, 2016   Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today that it is ... a video of two patients who tell their personal story and encourage those at risk ... Meet Jacque: Hepatitis C ... ... Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.) ...
(Date:5/3/2016)... May 3, 2016  Forté Elements, LLC (Forté) is excited to announce the launch ... address the nutritional needs of recovery for a variety of clinical conditions. Founded in ... Photo - http://photos.prnewswire.com/prnh/20160502/362548 Logo -  http://photos.prnewswire.com/prnh/20160502/362547LOGO ... ... ...
(Date:5/2/2016)...  Deerfield announced today it led the $44.5 ... Graybug Vision is an early stage pharmaceutical company ... for ocular diseases including wet age-related macular degeneration ... developed at Johns Hopkins University and has been ... Graybug Vision is developing ophthalmology products enabling ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... 04, 2016 , ... Trinity Health today launched its inaugural ... aimed at improving care and reducing readmission rates for patients who are dually ... Health is to drive innovation that transforms our ministry and our industry to ...
(Date:5/4/2016)... SCOTTSDALE, AZ (PRWEB) , ... May 04, 2016 ... ... 2016 Annual Technology & Business Conference. The conference opened on Tuesday with Frank ... panel discussion on NCPDP’s PDMP Solution provided a deep dive on NCPDP’s model ...
(Date:5/4/2016)... ... ... Level 10 Head Over Heels Athletic Arts’ gymnast Alessandra Brovedani -- who goes ... fall of 2019. , After a handful of college visits, the Berkeley High ... her connection with the coaching staff and the excitement surrounding Wildcat Athletics. , “What ...
(Date:5/4/2016)... (PRWEB) , ... May 04, 2016 , ... ... therapy products, announced today the introduction of the innovative newly improved Iso-Hip Wrap. ... hip replacement patients. The plush design enhances comfort and enables the patient to ...
(Date:5/4/2016)... , ... May 04, 2016 , ... Nike Rugby Camp's ... rugby in San Diego. Willis, founder of Elite Rugby Camps and current Nike Camp ... players every year since 2009. , “I’m excited for our eighth summer here ...
Breaking Medicine News(10 mins):