HeartWare International Clinical Trial Shows 90% Survival At 180 Days

Main Category: Cardiovascular / Cardiology
Also Included In: Transplants / Organ Donations;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 25 Apr 2009 - 1:00 PDT

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HeartWare International, Inc. (Nasdaq: HTWR) (ASX: HIN) 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.

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.

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

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