Boston Scientific
(NYSE: BSX)
announced today that it initiated the AVANT GUARD clinical trial to evaluate its Farapulse pulsed-field ablation (PFA) system.
The company also says it now anticipates FDA approval for Farapulse in the first quarter of 2024.
AVANT GUARD looks at the safety and effectiveness of Farapulse as a first-line treatment for persistent AFib. Boston Scientific says this makes it the only trial studying the use of PFA as a frontline therapy in patients with this form of AFib.
Farapulse is already a known commodity in the competitive PFA space. The nonthermal treatment uses electric fields to selectively ablate heart tissue.
Boston Scientific bought Farapulse for nearly $300 million in 2021. The company shared its high hopes for the technology at its Investor Day event earlier this year, with analysts projecting FDA approval and rapid adoption in the near future.
Earlier this month, though, Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib.
The new trial from Marlborough, Massachusetts-based Boston Scientific looks at Farapulse as a first-line persistent AFib treatment. Outcomes will be compared to outcomes following use of anti-arrhythmic drug (AAD) therapy, a common treatment for persistent AFib.
“The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilized as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the Farapulse PFA system as the preferred method for treating the disease,” said Dr. Brad Sutton, chief medical officer, AFib Solutions, Boston Scientific.
The analysts’ view on the latest Farapulse development
BTIG analysts Marie Thibault and Sam Eiber say the accelerated timeline sets Farapulse up for approval sooner than expected. Previous projections had the approval coming in the second half of 2024. They wrote that they think FDA approval is “derisked” following positive study data presented in August.
As previously stated, the analysts expect “rapid physician adoption” for PFA once commercially available. A recent check performed by the analysts showed that operators indicated that they expect to use the procedure in half of their AFib ablation cases in the third year following the first set of launches.
Thibault and Eiber also point to an extension arm of the study evaluating the new Farapoint focal PFA catheter. This technology performs cavotricuspid isthmus (CTI) ablations to treat atrial flutter. Boston Scientific expects FDA approval for Farapoint in 2025.
Additionally, the analysts say Boston Scientific has plans to launch the new Farawave Nav catheter and Faraview software, which will integrate with its Rhythmia mapping system, by the end of 2024.
“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 U.S,” the analysts wrote. “We do not make any changes to our estimates at this time. Reiterate Buy.”
More details on the Boston Scientific Farapulse trial
Boston Scientific plans to enroll more than 500 patients with persistent AFib across 75 global sites in the AVANT GUARD trial. It expects to randomize patients to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using Farapulse, or receive AAD treatment, with three years of follow-up.
According to Boston Scientific, the trial looks at therapy outcomes, including device- or procedure-related adverse events. It also evaluates freedom from AFib, atrial flutter or atrial tachycardia, as well as AFib burden.
The company also plans to implant its LUX-Dx insertable cardiac monitor in all patients in the trial. This device simplifies the monitoring process by automatically capturing and transmitting arrhythmia episode data. Boston Scientific designed it to detect recurrence of cardiac arrhythmias and assess AFib burden with continuous rhythm monitoring.
Dr. Oussama Wazni oversaw the first patient enrolled at the Cleveland Clinic this week. Wazni serves as lead investigator for the trial.
Recent clinical trial data backed up Farapulse ahead of this new trial. Data from more than 17,000 patients in the MANIFEST 17K registry reinforced the real-world safety profile for the pulsed-field ablation (PFA) system. Results included no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury. The company reported an overall major adverse event rate of less than 1%.
“With nearly 40,000 patients treated to date in clinical and commercial settings, the Farapulse PFA system continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build,” Sutton said.