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:6/24/2016)... June 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... innovative inhaled drugs, announced today that it was added ... reconstituted its comprehensive set of U.S. and global ... is an important milestone for Pulmatrix," said Chief Executive ... awareness of our progress in developing drugs for crucial ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... Lafayette, California (PRWEB) , ... ... ... a pioneer in the patient payment industry today announced its strategic partnership ... and health system workflows. , The two companies’ proven, proprietary technology combine ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest ... . , Millions of individuals in the United States and Canada wear eyeglasses. Once ... to both correct vision and make a fashion statement. Even celebrities use glasses as ...
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet ... product that was developed to enhance the health of felines. The formula is all-natural ... two main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews ...
Breaking Medicine News(10 mins):