Medtronic becomes first company to win FDA approval for new treatment of irregular heartbeats

In a closely watched medical development, Medtronic edged out competitors in securing U.S. Food and Drug Administration approval for a new cardiac device designed to treat a specific type of irregular heartbeat.

The FDA approved Medtronic's PulseSelect Pulsed Field Ablation (PFA) system to treat both paroxysmal and persistent atrial fibrillation, or AFib.

More than 6 million Americans suffer from AFib, according to Medtronic. Competitors Boston Scientific Corp. and Johnson & Johnson are both developing similar products, but Medtronic's should be first to market with the FDA approval. Both doctors and Wall Street have been tracking the race to develop an AFib-specific treatment.

"Yes, there is a lot of competition. This is the first in the U.S.," said Khaldoun Tarakji, chief medical officer for Medtronic Cardiac Ablation Solutions.

PulseSelect uses pulsed electric fields to isolate the pulmonary veins for treatment. Tarakji said that PulseSelect is a breakthrough for treating AFib.

"It means a lot. It's not just a new device. It's a new energy source," said Tarakji who was with the acclaimed Cleveland Clinic before joining Medtronic in 2022.

Medtronic has been developing pulse field ablation technology for 15 years, Tarakji said.

"Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for [AFib] ablation with excellent efficacy and efficiency," said Rebecca Seidel, president of the Cardiac Ablation Solutions business, in a statement.

Ablation has long been a treatment for AFib. The process uses heat or cold energy to create small scars in the heart which block faulty electrical signals and restores a regular heartbeat. PulseSelect is a new type of ablation.

"With traditional thermal technology, one of the downsides is the complications that can happen," Tarakji said. Those complications can be life-threatening.

In a global clinical trial of PulseSelect with 300 patients Medtronic recorded an adverse event rate of 0.7% meaning that few patients saw any problems. The company also found that more than 80% of patients did not have any recurring symptomatic atrial arrhythmias.

"A big component of this is the safety," Tarakji said.

The American Heart Association indicates that AFib can lead to blood clots, heart failure and other heart-related complications. Untreated AFib significantly raises the risk of strokes and heart-related deaths.

Paroxysmal AFib is a short-term episode that could last a few seconds or days. Persistent AFib lasts longer than a week. Currently, treatments include medications and a cardioversion procedure, which resets the heartbeat.

Medtronic will start selling PulseSelect in early 2024.

The company acquired Affera Inc., which produces treatments for arrhythmias, for $904 million in 2022.

Medtronic won European approval for the Affera Mapping and Ablation System in March.