Boston Scientific Corp. reported the controlled launch of its Acurate Neo2 aortic valve system in Europe. The next-generation transcatheter aortic valve implantation (TAVI) technology extends the clinical performance of the original Acurate Neo platform and includes an expanded indication for patients with aortic stenosis.

Intended to restore function and normal blood flow through a severely narrowed aortic valve, the enhanced system features new annular sealing technology designed to further reduce paravalvular regurgitation (PVL) around the valve and enable physicians to treat additional patients, including those with irregular, calcified anatomies.

Additionally, the delivery system enhancements make it easier to access small and complex vessels at the entry site and facilitate highly accurate valve positioning. A top-down deployment apparatus further supports stable placement and release of the device, ensuring better patient outcomes.

The new valve also includes an expanded indication for patients with aortic stenosis, regardless of age or risk level, if their heart team, or a cardiac surgeon, believes they are an appropriate candidate for the device.

Dual-valve approach

“We anticipate that the Acurate Neo2 valve system will allow European physicians to treat even more patients – including those with irregular or calcified anatomies – compared to the original Acurate Neo platform, which is already considered an all-comers, workhorse valve,” Joe Fitzgerald, Boston Scientific president of interventional cardiology, told BioWorld. “Together with the Lotus Edge system, our dual-valve portfolio covers a wide range of patient needs across Europe and will position us for long-term leadership in this substantial market.”

Lotus Edge is the company’s next-generation Lotus transcatheter aortic valve replacement (TAVR) system. It is indicated for patients who cannot undergo or are at high risk for open heart surgery.

The Acurate Neo2 system received the green light from the European Commission in April, based on data from the Acurate Neo2 CE mark study. Results from the 120-patient clinical trial showed PVL rates for the next-generation valve system to be lower than those reported with the Acurate Neo valve. At 30 post-implantation, 97% of patients experienced ≤ than trace or mild PVL and 3% experienced moderate PVL. At one year, rates of trace/mild and moderate PVL were 97.5% and 2.5%, respectively. No patients experienced severe PVL after being implanted with the valve.

“We are pleased to bring the latest iteration of Acurate technology to market, offering design improvements that further support procedural performance and optimal outcomes for patients with symptomatic aortic stenosis, from those with simple to the most challenging anatomies,” said Ian Meredith, executive vice president and global chief medical officer of the Marlborough, Mass.-based company.

He added that the straightforward implant procedure also allows doctors to release patients from the hospital sooner without risking their safety or clinical outcomes.

IDE study

The company is currently conducting the ACURATE IDE (Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of AUCURATE in Subjects InDicatEd for TAVR) study to support U.S. FDA approval. The prospective, multicenter, 360-patient trial is slated for primary completion in November. Patients are randomized to receive the Acurate Neo2 transfemoral TAVR system or either the Corevalve TAVR system by Medtronic plc or Edwards Lifesciences Corp.’s Sapien 3 TAVR system.

The primary safety outcome is the composite rate of all-cause mortality, all stroke, life-threatening and major bleeding, stage 2 and 3 acute kidney injury and major vascular complications at 30 days. The major effectiveness endpoint is the composite rate of all-cause mortality and disabling stroke at one year.

The trial includes a 4D CT imaging substudy to assess the incidence of reduced leaflet mobility and hypoattenuated leaflet thickening and the impact, if any, on clinical events, with patients randomized to Acurate Neo or one of the control devices.

As the TAVR field matures, companies are finding it increasingly difficult to develop new implants with enhancements that stand out against competitors. In an investigator-led study presented last fall at last year’s Transcatheter Cardiovascular Therapeutic conference, known as Scope I, the original Acurate Neo did not demonstrate noninferiority to Edwards’ Sapien 3 TAVR.

“We continue to enroll patients in the U.S. ACURATE IDE clinical trial to support approval of the Acurate Neo2 valve system in the U.S.,” Fitzgerald said. “That milestone, in addition to Lotus Edge, are the key elements of our two valve strategy to treat the growing number of patients suffering with aortic stenosis.”

Eye on pulse field ablation

Interventional cardiology isn’t the only area where Boston Scientific is making news. Last week, the company said it had inked an investment deal with an exclusive option to acquire Menlo Park, Calif.-based Farapulse Inc., a privately held company developing a pulsed field ablation (PFA) system to treat atrial fibrillation and other heart arrhythmias. Farapulse’s PFA – which includes a sheath, generator and catheters – is designed to ablate heart tissue by creating a therapeutic electric field, rather than using thermal energy sources such as radiofrequency ablation or cryoablation.

Farapulse received FDA breakthrough status for its endocardial ablation system in May 2019. The company is looking to do a clinical trial in the U.S. and is pursuing CE marking in Europe.

Cowen analyst Joshua Jennings called pulsed field ablation technology a “potential future game-changer” for the treatment of atrial fibrillation.

“For BSX, the Farapulse agreement underscores the company’s ongoing commitment to strengthening its electrophysiology offerings,” he wrote, citing recent CE marks for Polarx, a second-generation, single-shot cryoablation catheter, as well as its Stablepoint force-sensing catheter.

“This differentiated European portfolio will eventually migrate to the U.S. Notably, management has indicated that it will be disappointed if the company only has a 20% market share in atrial fibrillation over time,” Jennings said. “The latest Farapulse agreement enhances the company’s positioning in Afib and should strengthen its conviction regarding its long-term commercial prospects in the field.”