Devices & Diagnostics

HeartWare seeks pre-market approval for cardiac assist device

HeartWare International Inc. files a pre-market approval application with the Food & Drug Administration for a ventricular assist device designed as a bridge-to-transplant system. HeartWare International Inc. (NSDQ:HTWR) filed a pre-market approval application with the Food & Drug Administration for its cardiac assist device. The Framingham, Mass.-based company’s ventricular assist system is designed to provide […]

HeartWare International Inc. files a pre-market approval application with the Food & Drug Administration for a ventricular assist device designed as a bridge-to-transplant system.

HeartWare International Inc. (NSDQ:HTWR) filed a pre-market approval application with the Food & Drug Administration for its cardiac assist device.

The Framingham, Mass.-based company’s ventricular assist system is designed to provide a temporary “bridge” for heart transplant patients with “end-stage heart failure,” according to the company.

Patients implanted with the device in HeartWare’s Advance clinical trial had a 94 percent survival rate, according to the company.

The company closed a $143.8 million debt offering and investor Apple Tree Partners completed the sell-off of 1 million shares for more than $81 per share in December.

A PMA is a regulatory pathway to market medical devices that have no incumbent products with which the FDA can compare the safety.

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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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