Boston Scientific’s Acurate Neo2 TAVR Device Evaluated for Hemodynamic Performance and Clinical Outcomes

June 8, 2022—Boston Scientific’s current-generation Acurate Neo2 aortic valve system demonstrated positive hemodynamic performance and clinical outcomes in new data from the NEOPRO and NEOPRO2 registries.

As reported by the company, the investigator-driven study included retrospective registry data from a total of 2,026 patients from 34 European centers. Investigators compared outcomes with the previous-generation Acurate Neo valve from the NEOPRO registry (1,263 patients, 18 centers) with those of the Acurate Neo2 valve from the NEOPRO2 registry (763 patients, 16 centers).

The Acurate Neo and Acurate Neo2 aortic valve systems have received CE Mark approval for transcatheter aortic valve replacement (TAVR). In the United States, Acurate Neo2 is an investigational device and restricted under federal law to investigational use only.

Andrea Scotti, MD, of the Montefiore Medical Center in New York, New York, delivered the new findings in a late-breaking presentation at TVT: The Structural Heart Summit, the annual meeting of the Cardiovascular Research Foundation, held June 8-10, 2022, in Chicago, Illinois. The study was simultaneously published by Dr. Scotti et al online in EuroIntervention.

Key findings included a significant reduction in moderate or severe paravalvular aortic regurgitation (PAR) for the Acurate Neo2 valve compared to the Acurate Neo (2% vs 5%; P < .001). This reduction contributed to meeting the primary endpoint, with a higher Valve Academic Research Consortium-3 (VARC-3) Update intended valve performance—defined as mean gradient < 20 mm Hg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation—with the Acurate Neo2 valve (96% vs 90%; P < .001). The findings were driven by superior performance of the Acurate Neo2 valve for patients with heavy aortic valve calcification, noted the company.

Additionally, there was a significant reduction in mild PAR with patients receiving the Acurate Neo2 valve, with a greater proportion of none/trace PAR compared to Acurate Neo (38% vs 59%; P < .001).

Finally, in the secondary endpoint, there was similar 30-day results with Acurate Neo2 and Acurate Neo for VARC-3 technical success (93% vs 91%; P = .117), device success (84% vs 81%; P = .119), and 1-year survival after TAVR (90% vs 87%; P = .14).

According to the company, the favorable outcomes from this study reinforce the enhanced ability of the sealing technology in the Acurate Neo2 valve to minimize paravalvular leak (PVL) and align with previous studies demonstrating low rates of PVL and need for permanent pacemaker implantation, excellent hemodynamics, and a very high device success rate—as recently reported in the ITAL-neo registry, the first retrospective comparison of the two TAVR iterations, published by Andrea Buono, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions (2022;15:1101–1110).

Boston Scientific has previously noted that the Acurate Neo2 valve system received CE Mark approval and was launched in Europe in 2020. The device is indicated for patients with aortic stenosis—with no specified age or risk level—who are considered appropriate candidates for TAVR by their heart team, including a cardiac surgeon.

Also, the company is conducting the pivotal ACURATE IDE investigational device exemption trial in the United States that is evaluating the safety of the Acurate Neo2 aortic valve system. In April 2021, the company received FDA approval to modify the trial design to study patients with severe, symptomatic aortic stenosis who are at low risk of open heart surgery, in addition to those at intermediate, high, and extreme risk.