UPDATED Oct. 28, 2011, with reaction from Medtronic
Medtronic’s (NYSE:MDT) cardiac ablation device is effective but too risky to approve for a type of atrial fibrillation, according to an FDA advisory panel.
“To the sponsor, I hope what you’ve heard today is not a ‘no,’ but a ‘not yet,'” said Dr. Clyde Yancy, chairman of the watchdog agency’s circulatory devices panel, according to Reuters. “There is a feeling that this system is effective, but there are concerns that the safety bars have not been met.”
The FDA is not bound by its advisory panels’ recommendations, but it often follows their guidance.
"While we are disappointed with today’s outcome, Medtronic looks forward to continuing discussions with the FDA to determine the best path forward," said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions unit, in prepared remarks. "We believe this technology would represent an important option for the persistent or long-standing persistent atrial fibrillation population, for whom treatment is limited."
The device, which Medtronic acquired when it bought Ablation Frontiers in 2009, uses radiofrequency energy to destroy the heart muscle cells that cause persistent atrial fibrillation – an irregular heartbeat that lasts between seven days and four years and is a major cause of stroke, according to the news agency.
Although it proved effective in treating persistent AF in patients who didn’t respond to standard drug therapy, the device failed to meet a clinical trial’s safety endpoint, according to an FDA report released ahead of yesterday’s panel hearing.
The circulatory devices panel voted 8-2 that the device’s risks are greater than its benefits. Nearly 3 percent of patients in the 176-subject trial had a stroke less than a month after treatment and 21.6 percent experienced a major adverse event.
But 55.8 percent showed normal heart rhythms within six months, compared with 26.4 percent of patients in the control group, who were treated with standard anti-arrhythmia drugs.