Boston Sci Initiate New Farapulse Trial, Move up Anticipated FDA Approval Date

With only days left in 2023, Boston Scientific has announced the initiation of the Avant Guard clinical trial to evaluate the safety and effectiveness of its Farapulse Pulsed Field Ablation (PFA) system as a first-line treatment for persistent atrial fibrillation (AF), cementing the increased likelihood of intense competition in the PFA market in 2024.

The study will compare the outcomes of ablation with Farapulse — a nonthermal treatment in which electric fields selectively ablate heart tissue — with use of anti-arrhythmic drug (AAD) therapy, a commonly prescribed therapy for patients with persistent AF. Following more than 500 patients diagnosed with persistent AF at up to 75 sites globally for three years, the randomized trial will split patients into two groups, those who undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using Farapulse, and those who receive AAD treatment.

Over the three years of observation, therapy outcomes will be evaluated, including device-or-procedure-related adverse events, the rates of freedom from AF, atrial flutter, or atrial tachycardia, and AF burden — a measurement of the amount of AF an individual experiences, according to the press release announcing the study.

Additionally, all patients enrolled in the trial will be inserted with the company’s Lux-Dx Insertable Cardiac Monitor to automatically capture and transmit arrhythmia episode data as well as assess AF burden by providing continuous rhythm monitoring.

With the announcement of the study, Boston Scientific also moved up its anticipated FDA approval date to the first quarter of 2024, continuing the positive path towards regulatory approval company said it sees for the technology after buying it for nearly $300 million in 2021.

In fact, earlier this year, BTIG analysts left Boston Scientific’s Investor Day excited about Farapulse updates. “We left bullish on BSX’s packed pipeline, star products like Farapulse and the Watchman platform, as well as the stacked contributions from numerous product launches across all business segments,” analysts Marie Thibault and Sam Eiber wrote at the time.

Additionally, in August, Boston Scientific shared positive 12-month results from its Advent trial of Farapulse evaluating the treatment for ablating heart tissue in patients with AF. The study marked the first randomized trial directly comparing the efficacy and safety of the system against standard-of-care ablation like radiofrequency or cryoablation for treating paroxysmal or intermittent AF.

And complementary studies are in the works.

Enrollment was completed in the third quarter of 2023 for the first phase of the company’s Advantage AF clinical trial, which will study the system for treatment in patients with drug refractory symptomatic persistent AF. Enrollment commenced in an extension arm of the study as well, evaluating the safety and effectiveness of adjunctive use of Farapoint PFA Catheter for cavotricuspid isthmus ablations — a procedure to treat atrial flutter.

After the Avant Guard trial news broke, BTIG analysts were quick to label the accelerated FDA approval timeline as “derisked” based on the positive data released from the Advent trial in August, reiterating a recommendation to buy stock.

“Overall, we remain bullish on Farapulse and believe it could drive an incremental 1-2 points of annual total company organic growth, once approved in the US,” they said. “We do not make any changes to our estimates at this time. Reiterate Buy.”

But, Boston Scientific is not the only company banking on PFA for 2024 as it awaits FDA nod.

Only weeks ago, Medtronic became the first to win FDA approval for a PFA system. The company’s PulseSelect PFA system, which treats both paroxysmal and persistent AF, is slated for US commercialization in early 2024. The approval came only one month after it obtained CE Mark. Johnson & Johnson Medtech is also working on its contribution to the space with the Varipulse PFA catheter.

And it seems electrophysiologists, interventional cardiologists, among other specialists, are waiting with bated breath to start utilizing the technology.

BTIG analysts conducted a poll of 25 US electrophysiologists and interventional cardiologists to see how they would adopt PFA technology, assuming a scenario in which PulseSelect and Farapulse have obtained approval by Jan. 1, 2024, and J&J’s Varipulse by January 2025.

Thibault detailed the poll results, explaining that “in the year following FDA approval for Farapulse and PulseSelect, Farapulse is expected to secure 14% market share, while PulseSelect will be used in 9% of cases. This shift comes from an 18-point decline in RF share and two points away from cryo,” according to the analysis. “However, nearly half of doctors expect to continue increasing their overall procedure volume in the first year of PFA availability and add PFA case volume at a level that more than offsets their planned reduction in traditional ablation cases. In the year following FDA approval for Varipulse and Sphere-9 systems, Varipulse wins 10 points of market share, Sphere-9 secures 4 points, and Farapulse holds 16 points of share.”

She continued, “In the third year following the first PFA launches, traditional ablation is expected to be used in roughly half of ablation cases (42% RF, 10% cryo), while PFA takes the other half (16% Farapulse, 13% Varipulse, 10% PulseSelect, and 7% Sphere-9.) This matches what we have heard in diligence over the past four years, including an expectation that PFA will quickly become standard of care and that there will be more than one winner in PFA.”

Going into what will surely be the 2024 battle of PFA devices, can anyone else hear the distant hum of the John Cena theme song?