A new technique for treating patients with a common heart arrhythmia is rapidly replacing traditional methods in one of medtech’s biggest developments this year.
Atrial fibrillation (AFib), the heart rhythm disorder, affects 50 million people worldwide, yet less than 5% of those who could benefit from a cardiac ablation procedure to address it now get treated, according to Jasmina Brooks, president of Johnson & Johnson’s Biosense Webster subsidiary.
Heart device makers including J&J believe they have a solution to narrow that gap, a procedure called pulsed field ablation (PFA). The technology has sparked tremendous buzz among heart specialists and Wall Street analysts, who predict speedy adoption of the new technique.
“We believe that PFA will expand that market and hopefully help us improve that less than 5% number and improve the access for people who are impacted by AFib. That's probably the biggest benefit that we expect from PFA,” Brooks said in a recent interview.
AFib causes the heart to beat inefficiently, increasing the risk of stroke or heart failure, and its prevalence is growing as the population ages. Drugs don’t always work to restore normal heart rhythm in AFib patients. PFA promises faster procedure times than traditional ablation methods and may be safer for patients.
PFA applies nonthermal energy to correct faulty electrical signals in the heart. A catheter targets specific heart cells with high-voltage electrical pulses, reducing the risk of injury to surrounding tissue.
The technology differs from older techniques like radiofrequency ablation (RFA), which uses heat to scar heart tissue and block abnormal signals that cause AFib, and cryoablation, which uses extreme cold to target tissue.
“Physicians both in the U.S. and [outside the] U.S. are excited to try the innovation,” Brooks said. “They're excited about the promise of safety, efficiency, workflow efficiencies as well. Those continue to be really key considerations to adopting the new technology.”
The first PFA systems to hit the U.S. market — Boston Scientific’s Farapulse and Medtronic’s Pulseselect —started rolling out this year. Boston Scientific’s Advent pivotal trial was a tipping point for the industry, according to analysts, when the results last fall showed PFA to be as effective as RFA and cryoablation, and potentially safer.
“There is the belief that it's safer and that was supported by the Boston trial, which was a head-to-head trial with RF ablation, and then there was a secondary safety endpoint where it showed it was superior,” said Needham analyst Mike Matson.
Shorter procedure times are a big part of the technique’s appeal, allowing doctors to increase their case volumes. “That throughput matters a lot to hospitals,” said BTIG analyst Marie Thibault.
‘Very rapid’ uptake
Boston Scientific CEO Mike Mahoney touted Farapulse as a “transformational” product for the company in a first-quarter earnings update. The CEO pointed to a “very rapid” uptake from users of both RFA and cryoablation.
Mahoney declined to disclose initial sales figures for Farapulse, which was launched midway through the quarter. However, BTIG’s Thibault thinks revenue from the device could have reached $40 million to $50 million in that short time.
“It is a very high number, certainly the most successful medical device launch that we can think of,” Thibault told MedTech Dive.
Before PFA, radiofrequency energy was the preferred approach in roughly 85% of AFib ablation procedures, said Thibault. Meanwhile, cryoablation comprised about 15% of cases.
After Boston Scientific’s Advent data were released, BTIG surveyed 25 heart doctors who on average expected to shift half of their AFib procedures to PFA in three years. Thibault predicted that number could be closer to 60% because the technology now appears headed for even faster adoption.
Like Boston Scientific, Medtronic has reported high interest in its PFA technology, with cardiovascular group President Sean Salmon citing “astonishingly great” demand on the company’s earnings call in May. Medtronic was first out of the gate in the U.S. with a December approval for Pulseselect.
Medtronic executives also were mum on PFA sales, but CEO Geoff Martha said the products drove 21% sequential growth in the company’s cardiac ablation business in its fiscal fourth quarter, as the technology more than offset declines in its cryoablation line.
Mapping the procedure
J&J, which filed an FDA submission in March for its Varipulse platform, is on track to become third to the U.S. market with a PFA system that will likely launch later this year, said RBC Capital Markets analyst Shagun Singh. J&J expects the integration of Varipulse with its Carto heart mapping system to distinguish its PFA offering from the competition.
Mapping helps physicians determine where to ablate before the procedure and confirm the results afterward. J&J has a huge installed base of mapping systems, said Singh.
Boston Scientific is looking to integrate mapping with PFA this year, and Medtronic recently filed for U.S. approval of its Affera mapping and ablation system.
Abbott also has a mapping system on the market but is lagging in the PFA race. The company announced in January that it completed the first procedures in a study of its Volt PFA device and expected to receive approval to start a U.S. clinical trial, leading analysts to predict the system could be introduced in the U.S. in 2026. It began enrolling patients in the U.S. study in April.
With PFA rollouts and more expected approvals shaking up the competitive landscape in AFib treatment, the electrophysiology market “is going to be very dynamic for the next two to three years,” said Singh.
Device makers overall have continued to post strong revenues from radiofrequency procedures, said BTIG’s Thibault, noting the enthusiasm around PFA is “lifting all boats for ablation in general.”
