Medtech giant Medtronic (NYSE:MDT) enrolled the 1st patient in a new clinical trial assessing its Phased RF System, a device that delivers radiofrequency ablation to muscles of the heart in order to treat persistent or long-standing persistent atrial fibrillation.
If successful, the trial could help support another run at FDA review for the ablation system, which was snubbed in 2011 by the FDA’s Circulatory Systems Devices advisory panel.
The Phased RF technology, already approved in parts of Europe, Asia, Africa, Australia and Canada, delivers tailored radiofrequency energy intended to disrupt abnormal impulses in the left atrium of the heart. Medtronic acquired the technology when it bought Ablation Frontiers in 2009.
A 2011 FDA advisory panel voted that the device was effective but too risky to approve for patients with persistent or long-standing persistent atrial fibrillation. Ablation therapies are currently approved in the U.S. only to treat paroxysmal AF, the mildest form of the disease.
Medtronic plans to enroll up to 350 patients at 40 clinics around the country, primarily looking to establish 30-day procedure- and device-related stroke rates at or below 1.8%. Researchers will also examine 6-month treatment effectiveness, acute procedural success and rates of pulmonary vein stenosis.
In Medtronic’s previous 176-patient trial, nearly 3% had a stroke less than 1 month after treatment, and 21.6% experienced a major adverse event. More than half, however, showed normal heart rhythms within 6 months, compared with 26.4% of patients in the control group, who were treated with standard anti-arrhythmia drugs.
The new trial sounds like good news for Medtronic, which earlier today also announced the $160 million acquisition of surgical infection prevention products provider TYRX.
Medtronic shares were trading up by 2.2% this afternoon, going for about $59.64 apiece as of 2:30 p.m.