FDA Approval and CE Mark for Medtronic’s Arctic Front Advance® ST Cryoballoon

Medtronic plc tells us its Arctic Front Advance® ST Cryoablation Catheter has received U.S. FDA approval for the treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation. And in Europe, the device has received CE Mark for the broader indication of treating patients with atrial fibrillation.

Background

The Arctic Front Advance ST Cryoballoon is used in a minimally invasive procedure to isolate the pulmonary veins, which are a source of erratic electrical signals that cause atrial fibrillation. The device uses coolant rather than RF generated heat energy and is reportedly associated with shorter procedure times than point-by-point radiofrequency ablation. Indeed Medtronic cites references indicating better treatment outcomes than drug therapies on the market.

The Arctic Front Advance System has been shown to improve quality of life for patients and significantly reduce paroxysmal atrial fibrillation symptoms, with patients experiencing reduction in atrial fibrillation episodes, palpitations, fatigue, rapid heartbeat, swelling, and syncope, and has become a widely adopted treatment for atrial fibrillation. It is the only cryoballoon system approved in the U.S. for the treatment of paroxysmal atrial fibrillation and in Europe for treatment of atrial fibrillation. It has been used to treat more than 120,000 patients in more than 50 countries worldwide.

An integral part of the Arctic Front Advance® System, the third-generation cryoballoon has a 40 percent shorter tip than the previous generation, designed to help physicians visualize ablation success in real-time with the Achieve® Mapping Catheter, as well as allow increased maneuverability for accessing some pulmonary vein anatomies.

A first patient was recently treated with the Arctic Front Advance ST Cryoballoon by Prof. Karl-Heinz Kuck, M.D., director of cardiology at Asklepios Klinik St. Georg, Hamburg, Germany. The product will be broadly available to physicians later this year, following a limited market release at the present time.

Physician comments

“I have had the opportunity to utilize the cryoballoon technology since its inception more than a decade ago,” said Prof. Kuck. “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.”

Company comments

“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,” said Reggie Groves, vice president and general manager of the AF Solutions business, part of the Cardiac and Vascular Group at Medtronic.

Source: Medtronic plc

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