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HeartWare International www.heartware.com

HeartWare International (ASX: HIN) is a medical device company developing a family of implantable Left Ventricular Assist Devices (LVADs) for the treatment of advanced heart failure.

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HeartWare International: Global demand for Ventricular Assist System delivers sharp rise in revenue

HeartWare International (ASX: HIN) has delivered a March quarter 2012 revenue of US$26.3 million (A$26.1 million), up on the March quarter 2011 result of US$18 million.

The increase was driven by a new quarterly high of global sales of the company’s HeartWare® Ventricular Assist System.

Sales of the device hit 298 for the quarter, compared to 207 units in the same period in 2011.

While the company still reported a net loss of $18.8 million, it held around $144.5 million in cash, cash equivalents and investments as of the end of the March quarter.

Earlier this week HeartWare announced it had completed patient enrolment in a pivotal destination therapy clinical study of its HeartWare® Ventricular Assist System in patients with end-stage heart failure.

This is the largest head-to-head ventricular assist device clinical trial to date with 450 patients enrolled.

Importantly, this marks a milestone for HeartWare with over 2,000 HeartWare® Ventricular Assist Devices now implanted globally.


Benefits outweigh risks

The U.S. Food and Drug Administration’s Circulatory System Devices Advisory Committee last month voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

This is an important step toward gaining market approval of the device in the U.S.

The advisory committee’s recommendation is now being considered by the FDA in its review of the premarket approval application submitted for the HeartWare® Ventricular Assist System.

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