Medtronic Earns Another PFA Approval, Is J&J Next in Line?
The Dublin-based company’s FDA nod arrives amid a surge of activity in the pulsed-field ablation market.
October 25, 2024
At a Glance
- Medtronic has received FDA approval for its Affera Mapping and Ablation System.
- Boston Scientific recently gained FDA clearance for its Farawave Nav Ablation Catheter while pausing its AVANT GUARD trial.
- Analysts predict the rapid adoption of PFA technologies.
It has been a week of heavy developments in one of the medical device industry’s hottest markets. From approvals to trial pauses – it has been a busy time for developers of pulsed-field ablation (PFA) technologies.
Medtronic is closing out the week with the announcement that it has won a nod from FDA for a second PFA option. The Affera Mapping and Ablation System with the Sphere-9 Catheter is indicated for the treatment of persistent atrial fibrillation and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.
The system won CE mark in March of 2023 and received Australian Regulatory approval in September of 2024. The Dublin-based company inherited the device when it acquired Affera in 2022.
"The significance of this innovative technology should be underscored; Affera is a game changer for treatment of Afib and atrial flutter," said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "The Affera system provides physicians with one safe, effective, and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of Afib."
The approval was based on the results demonstrated in the pivotal SPHERE Per-AF study(opens new window), an FDA IDE trial, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System.
Earlier this month, Medtronic announced the start of an early feasibility study( to evaluate the Sphere-9 catheter for treatment of ventricular tachycardia (VT), a cardiac arrhythmia in which the lower chamber of the heart beats abnormally fast.
In a research note, BTIG Analyst Marie Thibault wrote, “Affera's approval came largely in line with our timing expectations since Medtronic filed for approval in May or a bit earlier. With that in mind, we anticipate clearance for Johnson & Johnson’s Varipulse, which was submitted to FDA for PMA approval in March, to be announced soon as well.”
Image courtesy of Medtronic: The Sphere 9 Catheter
A Busy Week for PFA
Boston Scientific made the most noise in the PFA market this week. The Marlborough, MA-based company first announced it had received a nod from FDA for the Farawave Nav Ablation Catheter. The device enables cardiac mapping and PFA.
The company then announced it was pausing its AVANT GUARD trial, which is looking at how the company’s Farapulse PFA could treat a new patient population of drug-naïve persistent atrial fibrillation patients. Boston Scientific executives said the reason behind the pause was because of a few unanticipated observations in the trial.
The recent developments show this is one of the hottest markets in the medical device market. Thibault noted that there could be rapid adoption the space.
“We think that all four PFA platforms show excellent safety and efficacy profiles that are comparable to traditional thermal energy systems and enable faster procedure times,” Thibault wrote. “We remain bullish on PFA and continue to expect rapid commercial uptake in the U.S. as devices launch and new systems are approved.”
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