Navigation Links
HeartWare International Clinical Trial Shows 90% Survival at 180 Days
Date:4/24/2009

FRAMINGHAM, Mass. and SYDNEY, April 24 /PRNewswire-FirstCall/ -- HeartWare International, Inc. (Nasdaq: HTWR) (ASX: HIN) today announced updated results for its international clinical trial of the HeartWare(R) Left Ventricular Assist System. The results were presented by Dr. Martin Strueber, cardiothoracic surgeon at Hannover Medical School, at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) held in Paris this week. A full copy of the presentation was filed as part of a form 8-K with the U.S. Securities and Exchange Commission and can be accessed at www.sec.gov.

The data presented at ISHLT includes all 50 patients enrolled in the trial across 5 participating centers. The data show a survival rate of 90% at 6 months and a survival rate of approximately 86% at 12 months post implant*. On average, the patients were supported by the HeartWare(R) System for 300 days each. The cumulative duration of support across the group exceeded 41 years. The patients' quality of life showed significant improvement at all points post-implant and the rates of adverse events were relatively low despite the unusually long average duration of pump support across the patient group.

"These results appear again to confirm the benefits we believe to be inherent in the design of this device," said HeartWare CEO, Mr. Doug Godshall. "At the ISHLT meeting 12 months ago we reported a 90% survival among our initial patient cohort. It is pleasing to observe that this success rate has been maintained over a far larger patient group and over a longer period of time. We anticipate these positive data providing a meaningful stimulus as we make the system more broadly available in our International markets and as we accelerate enrolment in our US Bridge to Transplant clinical trial."

* The data includes all patients through February 26, 2009. As of today, 3 patients have yet to pass the endpoint of the international clinical trial and the last of these is expected to do so in early June.

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or Left Ventricular Assist Devices (LVADs), to treat patients suffering from advanced heart failure. The HeartWare(R) Ventricular Assist System features the HVAD(TM) pump, the only full-output pump designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has completed an international clinical trial for the device involving five investigational centres in Europe and Australia. The device is currently the subject of a 150-patient clinical trial in the United States for a Bridge-to-Transplant indication.

    For further information:
    www.heartware.com                            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

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, 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 technology :

1. Presentation of HeartWare Clinical Results
2. Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research
3. Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
4. Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections
5. Results of NeuroThera Effectiveness and Safety Trial - 2 (NEST-2) Presented at International Stroke Conference 2009
6. VIDEO from Medialink and International HIFU: New Prostate Cancer Procedure Being Tested in US Clinical Trials
7. Stem Cell Treatment Leader Tiantan Puhua Adds Experienced International Medical Staff for Expanding Numbers of Patients
8. Positive Phase II Study of Paciras EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress
9. Micromet Presents Data at the 23rd Annual Meeting of the International Society for Biological Therapy of Cancer on the Activity of Human Antibody Adecatumumab against KRAS-mutated Colon Cancer Cells
10. New International Study Shows Women With Symptomatic Fibroids Delaying Treatment Despite Substantial Burden on Quality of Life
11. In Vivo Data on Taligen Therapeutics Pipeline Candidates Presented at the XXII International Complement Workshop
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... 12 2016  OMS Supply, a large provider of ... announced today the recent launching of their new company ... of features that enhance the user experience and enable ... --> --> Despite ... company that started in early 2016, they have already ...
(Date:2/12/2016)... 12, 2016 Indiso ... den ungedeckten medizinischen Bedarf bei Lungen- und ... klinischen Forschungsprogramms bekannt. Das Programm, das sich ... ihrer respiratorischen Funktionen und anderer klinischer Parameter. ... Medizintechnikunternehmen, das sich auf den ungedeckten medizinischen ...
(Date:2/11/2016)... The primary goal of this research is to analyze ... of liquid biopsy. Key information the survey seeks to ... liquid biopsy adoption amidst future users - Predominantly used ... Sample inflow to conduct liquid biopsy tests - Preference ... on. - Correlation analysis of sample type and biomarker ...
Breaking Medicine Technology:
(Date:2/14/2016)... Laurel, NJ (PRWEB) , ... February 14, 2016 ... ... 14-20, 2016, the American Association of Heart Failure Nurses (AAHFN) is promoting healthier ... caregivers. This year’s campaign, Spices of Life! Healthy Living with Heart Failure will ...
(Date:2/13/2016)... ... February 13, 2016 , ... Many individuals looking to lead a healthy lifestyle ... reasons. IsoPasta by Isolator Fitness has delved into this niche allowing those giving ... high-carb repercussions. IsoPasta has 30 grams of protein and only 7 grams of ...
(Date:2/13/2016)... Salt Lake City, Utah (PRWEB) , ... February 13, 2016 , ... When an ... kids, Host Parents aren’t always sure what they are in for and they are often ... Pairs are more than they were hoping for. This year’s Au Pair of the Year ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, Ryan & ... purpose of these scholarships is to encourage applicants to pursue a degree in their ... these two parishes. , “We have available jobs in St. Landry and Evangeline ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... Each year, ... will be held in Anaheim, CA at the Anaheim Convention Center. Almost 10,000 physical ... see new therapy products in action, learn more about their chosen field and network ...
Breaking Medicine News(10 mins):