Medtronic (NYSE:MDT) said it won FDA approval for its Arctic Front Advance ST cryoablation catheter for treating atrial fibrillation, touting a 40% shorter tip than previous versions.
The Arctic Front Advance ST also won CE Mark approval for patients with atrial fibrillation. It’s the only approved device on the European market to use a cryoballoon to treat atrial fibrillation, the company said.
“The next-generation Arctic Front Advance ST cryoballoon builds upon the successful performance of the Arctic Front Advance system, and its shorter tip was designed in response to physicians’ needs in a real-world, clinical setting,” Medtronic vice president Reggie Groves said in a press release.
Medtronic landed pre-market approval for the initial Arctic Front device in 2010. It’s still the only cryoballoon system approved for the paroxysmal atrial fibrillation indication in the U.S., according to the Fridley, Minn.-based company.
Medtronic is running 2 clinical studies of the device in Europe. Data from these and other trials with the cryoballoon technology are due to be presented at the 2015 Heart Rhythm Society meeting in Boston this week.
The new Arctic Front device was used on its 1st patient by Dr. Karl-Heinz Kuck of the Asklepios Klinik St. Georg in Hamburg, Germany, Medtronic said.
“I have had the opportunity to utilize the cryoballoon technology since its inception more than a decade ago. By building upon clinical feedback from physicians worldwide, the third-generation system offers the potential for more real-time data and even better maneuverability that may further enhance the procedure,” Kuck said in a prepared statement.
