FDA’s Circulatory System Devices Panel will review HeartWare International Inc.’s miniature left ventricular assist system for use as a bridge to transplant in end-stage heart failure patients on April 25, the firm announced Feb. 14.

The HeartWare system incorporates the firm’s HVAD full-output, continuous flow, centrifugal blood pump. The miniature pump is designed to be implanted adjacent to the heart, avoiding the abdominal surgery generally required to implant left ventricular assist devices, according to the company.

HeartWare submitted a PMA for the device in December 2010 for use as a bridge to heart transplant, supported by its pivotal ADVANCE trial. The trial enrolled 140 patients at 30 U.S. hospitals between August 2008 and February 2010. (See Also see "News In Brief" - Medtech Insight, 3 January, 2011..)

The firm hopes to receive FDA approval later this year. The April 25 panel date “is generally consistent with our mid-2012 assumed U.S. approval,” noted Wells Fargo Securities analyst Larry Biegelsen in a Feb. 14 report. (See Also see "HeartWare Pipeline Update: HVAD On Track For 2012 PMA Approval" - Medtech Insight, 16 January, 2012..)

Upon FDA approval, the device is expected to provide a serious challenge in the U.S. to the market-leading HeartMate II system from Thoratec. (See Also see "HeartMate Meets Its Match? HeartWare VAD Data Has Good Showing At AHA" - Medtech Insight, 22 November, 2010..)

Headquartered in Framingham, Mass., HeartWare gained a CE mark for the bridge-to-transplant indication in 2009. The firm also is studying its flagship HVAD technology as a destination therapy in its 450-patient, U.S. ENDURANCE trial; 350 patients had been enrolled in the trial as of Jan. 31 and the company expects to complete enrollment by mid-year.

Sales up 50% in 2011

On Feb. 16, HeartWare reported fourth-quarter sales of $23.1 million, up 10.4% from the year-ago quarter. The total included $14.7 million in international sales and $8.4 million in sales related to U.S. clinical trials. For the full year, revenue of $82.8 million was up 50%. “Our results for 2011 reflect increasing confidence in the HVAD system,” CEO Doug Godshall said.

During the earnings call, the firm noted that it hopes to enroll additional patients in its ADVANCE bridge-to-transplant trial under an expanded continued access protocol. The firm says it anticipates FDA go-ahead for the new patients “within the next few weeks.”

HeartWare Gets FDA Panel Date For HVAD Heart Failure Implant

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