Boston Scientific earns FDA approval for afib-freezing cryo catheter

Boston Scientific is giving new meaning to the polar plunge.

The medtech giant has received FDA approval for a catheter that uses extreme cold to attack the irregular mechanisms of the pulmonary vein linked to paroxysmal atrial fibrillation—a version of AFib where symptoms come and go on their own, rather than staying constant for long periods of time.

The POLARx cryoablation system has been cleared in Europe since early 2020 and in Japan as of October 2021.

“The U.S. approval of the POLARx cryoablation system, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities,” Nick Spadea-Anello, president of Boston Scientific’s electrophysiology business, said in the company’s announcement Tuesday.

A key component of the system is the POLARx FIT catheter, an expandable balloon catheter that can be inflated to two different sizes with the push of a button, allowing doctors to better tailor the treatment to each patient’s anatomy.

Once inserted in the pulmonary vein, the catheter emits a very cold gas to freeze and scar over areas of tissue, with an aim of disrupting the irregular electrical signals causing AFib.

The POLARx FIT catheter received its own separate regulatory approvals in Europe, Canada and several Asia-Pacific markets earlier this year.

In a recent clinical trial, the results of which were presented at the Heart Rhythm Society’s annual conference earlier this year, 385 people with paroxysmal AFib were treated with the POLARx system. A year after their procedures, nearly 80% of participants were free from all documented atrial arrhythmias—a number that reached 88% among 50 patients who had been followed for an additional six months so far in a planned year-long extension of the trial.

Additionally, safety-wise, the study resulted in an event-free rate of 96% after the first year—and 100% in the first six months of the extension arm—including zero instances of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas.

“The new POLARx cryoablation system, and the expandable cryoballoon catheter specifically, is an exciting development for the effective treatment of AF, as it allows physicians to better tailor care for individual patients without sacrificing safety or efficiency,” Wilber Su, M.D., a principal investigator in the trial and director of electrophysiology at Banner University, said in Boston Scientific’s announcement.

“As we saw in clinical evaluation, the combination of maneuverability and variable balloon sizes makes this system particularly useful in addressing longstanding challenges with varying cardiac anatomies and brings to the table occlusion capabilities physicians aren’t used to seeing with traditional systems,” Su added.