FDA panel green lights Medtronic CRT-D bid

December 8, 2011 by MassDevice staff

An FDA panel sides with Medtronic, finding that its cardiac resynchronization therapy defibrillators are safe for an expanded population of patients, but is split on their effectiveness and whether the benefits outweigh the risks.

Medtronic logo

Medtronic (NYSE:MDT) won a positive vote from an FDA panel reviewing the med-tech titan's bid to expand approval indications for all of its cardiac resynchronization therapy defibrillators.

The panel agreed that patients with mildly symptomatic heart failure could benefit from CRT-Ds and that the benefits outweigh the risks, based on data from two Medtronic-sponsored clinical trials, RAFT and REVERSE.

A CRT-D resynchronizes the heart's lower chambers, which often beat out of sync in heart failure patients.

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"Today's favorable panel vote brings us one step closer to providing more heart failure patients with advanced treatment options that are proven safe and effective and can significantly improve survival and quality of life," MDT's cardiac rhythm disease management president Pat Mackin said in prepared remarks.

The FDA's Circulatory Systems Devices Advisory panel voted unanimously that CRT-Ds are safe for the expanded group of patients, but was split 3-to-2 on whether they are effective and whether the benefits outweigh the risks, voting ultimately in Medtronic's favor. The FDA isn't bound by the panel's decisions, but it often agrees with them.