Medtronic ($MDT) is looking to make its device the first to be FDA-approved for long-running atrial fibrillation, shaking off a 2011 setback and kick-starting enrollment in a new pivotal trial.
The Phased RF system uses radiofrequency energy to ablate tissues and treat instances of the dangerous heart rhythm disorder that last between 7 days and four years, the company said. Through the VICTORY AF trial, Medtronic will test the device in 350 long-lasting AF patients with the goal of convincing the FDA to make Phased RF a first-of-its-kind device--right now, the only approved AF-treating technologies are indicated for episodes lasting less than a week.
The latest trial is a second go-round for Medtronic after an FDA advisory panel ruled in 2011 that while Phased RF was plenty effective in preventing future strokes, the device's safety profile was questionable. With VICTORY AF, Medtronic's primary endpoint is a 30-day procedure-related stroke rate below 1.8%, and the company is confident it can succeed where its previous effort failed.
"In strong collaboration with the FDA, we designed the VICTORY AF trial to evaluate the safety of Phased RF ablation in patients who suffer with persistent or long-standing persistent AF," Medtronic AF chief Reggie Groves said in a statement. "We expect this trial will demonstrate its safety and benefit for this patient population."
Phased RF is made up of a generator and some multi-electrode catheters designed to counteract impulses in the left atrium that contribute to AF. The device is already approved overseas and has been used on more than 20,000 patients in 26 countries since 2009, according to Medtronic.
- read the statement