Chief Medical Officer Dr. Ken Stein explains the plans at Boston Scientific after its landmark pulsed field ablation approval.
On Jan. 31, Boston Scientific (NYSE: BSX) became the second company to receive FDA approval for a pulsed field ablation (PFA) system that treats AFib.
The landmark approval came just over a month after Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib in December.
Pulsed field ablation has generated a great deal of excitement in the medical device industry. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury-resistant.
At a September Investor Day event, Boston Scientific shared its high hopes for the technology, with Nick Spadea-Anello, the company’s president of Electrophysiology, declaring Boston Scientific’s belief that it’s leading the PFA space with Farapulse. (Note: Catheter design is a key innovative feature of the system.)
Boston Scientific can now offer Farapulse for the isolation of pulmonary veins to treat drug-refractory, recurrent, symptomatic, paroxysmal AFib. The company plans for an immediate U.S. launch.
In an interview with MassDevice shortly after the approval, Boston Scientific Chief Medical Officer Ken Stein shared the company’s enthusiasm surrounding the regulatory milestone.
“We’re thrilled. It really was fantastic to get the news,” Stein said. “We see this as a transformative technology. I think it’s transformative for Boston Scientific EP. And, I think — just as importantly — this is transformative for patients.”
What is Farapulse?
Farapulse, a nonthermal treatment, uses electric fields to selectively ablate heart tissue. It delivers pulsed field energy with the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable sheath. Boston Scientific’s VersaCross Connect access solution complements the sheath to provide safe and effective left heart access.
The Farawave catheter treats a range of pulmonary vein anatomies using an over-the-wire catheter with a variable basket and flower shapes. This allows for the device to adapt to individual patient anatomies.
Boston Scientific touts the system’s specific design, uniquely constructed for PFA.
“The approval of the Farapulse PFA system marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.,” Spadea-Anello, said in a news release announcing the approval.
Stein said a wealth of clinical and commercial experience demonstrates Farapulse as a safer option than conventional ablation. He notes that it’s at least as effective as that method and is more efficient, as well.
Entering a competitive market with one other approved product and many more vying for their own share, Stein sees Farapulse as a completely differentiated offering.
“Unlike a lot of the competitors out there, Farapulse is unique in that it was designed from the ground up as a pulsed field ablation system,” Stein said. “It’s not a repurposing catheter that was designed for something completely different. And it has well over a decade of preclinical experience and now clinical experience validating that we’ve got the right catheter design, the right waveform and an optimal dosing strategy.
“Farapulse, at this point, has by far — I mean literal orders of magnitude — more clinical data and more commercial experience than any of the competitors offer.”
Developing an acquired product
That buy reflected the company’s aggressive M&A strategy, which CEO Mike Mahoney outlined at that September Investor Day.
“M&A continues to be a focus area for us,” Mahoney said. “It reinforces category leadership, moving us into faster growth markets, which you hear often is our goal. “But, it’s actually what we do.”
Despite the acquisition being just under three years old, the company has actually worked with Farapulse for a decade, becoming an investor in Farapulse in 2014. As an early-stage investor in Farapulse well ahead of the acquisition, Boston Scientific always had a vested interest in the technology.
“We’ve been involved with them along their entire journey, from preclinical experimentation, through early human experimentation, through when they got CE mark and began their commercial release,” Stein said.
Stein said Boston Scientific has “a really good mix” of products developed internally versus those that it acquired.
“We’ve had a very active venture investing portfolio,” Stein said. “Quite a few of the acquisitions we’ve done involve companies where we were early-stage investors. When you’ve been with a company that long in their development, it really does make integrating them into Boston Scientific that much easier.”
What’s next for Boston Scientific?
While Boston Scientific can now market Farapulse to treat paroxysmal AFib, it now turns to persistent AFib. It’s currently in the midst of a follow-up trial looking to get FDA approval for that indication. The company is completing enrollment in the second phase of the multi-phase trial to test the next catheter in the Farapulse family.
The company plans to test the Farapoint catheter, a focal ablation catheter, as an adjunct to Farawave. It seeks to treat an arrhythmia called atrial flutter, targeting patients with both atrial fibrillation and flutter.
Then, Boston Scientific has the AVANT GUARD trial underway to look at Farapulse as a first-line persistent AFib treatment. Typically, Stein said, people with AFib go on some drug therapies before receiving a referral for ablation.
“Our view is that drugs have limited efficacy and a risk of some serious side effects,” he said. “Given all the advantages of Farapulse, we want to test and hopefully prove that there’s no point in even trying any of these meds in these patients. The bulk of these patients, we hope, would be best served by going straight to ablation with Farapulse.”
Boston Scientific won’t just bask in the FDA approval, either, with plans in the works for the next-generation Farawave catheter. It also has alternate catheter designs in development for treating different arrhythmias beyond AFib.
“In medtech, you can’t stand still, and you can never take things for granted,” Stein said. “We see ourselves as leaders in the pulsed field ablation space with Farapulse. We intend to continue to be leaders.”
See how Farapulse works in this video from Boston Scientific:
