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.
"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.
"As was seen in the RAFT and REVERSE trials, clinical evidence demonstrates that CRT-D prevents hospitalization and can save lives in mildly symptomatic patients," REVERSE investigator Dr. Michael Gold said in prepared remarks. "Utilizing this lifesaving therapy earlier in a milder heart failure population would allow us to treat these patients before their symptoms exacerbate, ultimately enabling us to better address this serious, often debilitating and costly disease."