Findings Presented for Boston Scientific’s Next-Generation Acurate Neo2 Aortic Valve System

May 18, 2021—Boston Scientific announced that data from the investigator-initiated EARLY neo2 and ITAL-neo registries were presented at the virtual EuroPCR 2021 conference. The company stated that the findings demonstrated positive procedural performance with the company’s Acurate Neo2 aortic valve system, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI).

According to the company, the EARLY neo2 registry is the first large real-world report of clinical experience with the Acurate Neo2 device. Andreas Rück, MD, presented findings from this retrospective analysis of 554 patients from 12 European centers, which included:

• 1.3% postoperative moderate/severe PVL rate, which was lower than the rate observed in previous studies with the Acurate Neo device. The mild and none/trace PVL rates were 33.3% and 65.4%, respectively
• 6% in-hospital PPI rate, 2.1% in-hospital stroke rate, 1.3% mortality rate at 30 days, and excellent hemodynamics (mean gradient of 9 mm Hg)

The company advised that Dr. Ruck also presented a poster in which EARLY neo2 registry data were evaluated in a separate quantitative assessment of angiographic aortic regurgitation in 228 patients treated with either the Acurate Neo valve system or Acurate Neo2 valve system. The results demonstrated that the Acurate Neo2 device was associated with significantly less aortic regurgitation when compared with the previous-generation Acurate Neo device.

The mean aortic regurgitation fraction rate was 4.4% with the Acurate Neo2 device versus 9.9% with the Acurate Neo device (P < .001). This equates to a 56% relative reduction in the mean aortic regurgitation fraction.

Andrea Buono, MD, presented data from the retrospective ITAL-neo registry, which included 95 patients receiving transcatheter aortic valve replacement (TAVR) at nine Italian centers and evaluated in-hospital device success and in-hospital patient outcomes with the Acurate Neo2 device. Findings included:

• 3.1% predischarge moderate/severe PVL rate; this rate, in addition to the mild and none/trace PVL rates (56.9% and 40%), was lower than previously reported rates in studies of the Acurate Neo device
• 7.9% device success rate, 1.1% in-hospital stroke rate, 11.2% in-hospital new PPI rate, and excellent hemodynamics (predischarge mean gradient of 8.2 mm Hg).

Boston Scientific advised 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.

The company is currently enrolling patients in ACURATE IDE, the pivotal 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.