Thirty-Day Results Presented for Boston Scientific's Acurate Neo2 Aortic Valve System
September 13, 2018—Boston Scientific Corporation announced findings from a new study evaluating the safety and performance of the company's Acurate Neo2 aortic valve system, a next-generation transcatheter aortic valve replacement (TAVR) system. The results from the single-arm, multicenter study, ACURATE NEO2 CE Mark study were presented at the annual congress of PCR London Valves in London, United Kingdom.
According to Boston Scientific, the study demonstrated a high procedural success rate and a low rate of paravalvular aortic regurgitation at 30-days postprocedure. Core laboratory adjudicated data showed 97% of patients had mild or less occurrence of paravalvular aortic regurgitation (PVL), defined as leakage of blood at the site of the valve implantation, which at high rates can indicate an increased risk of mortality. Data also demonstrated that the new Acurate Neo2 valve system could be implanted with a high procedural success rate of > 97%, very short device usage times, and low complication rates.
As summarized by the company, key 30-day results in the ACURATE NEO2 CE-Mark study include the following:
- All-cause mortality rate: 3.3%
- Disabling stroke rate: 1.7%
- Approximately 97% of patients had mild or less PVL; 3% had moderate PVL; and no observed cases of greater-than-moderate PVL
- A high procedural success rate: 97.5%
- A very short average device-usage time: 3.9 minutes
- Patients experienced marked hemodynamic improvement with the mean pressure gradient of 7.9 ± 3.2 mm Hg and effective orifice area of 1.7 cm2
The Acurate Neo2 valve system maintains key features of the original Acurate Neo aortic valve system including a self-expanding nitinol frame, supra-annular positioning, and a two-step, top-down deployment method. A new feature with the Acurate Neo2 is annular sealing technology is intended to further reduce occurrences of PVL. Additionally, the Acurate Neo2 delivery system's new radiopaque marker is designed to enhance the visibility of positioning and ease of use by clinicians to further improve procedural safety and efficiency. The Acurate Neo2 aortic valve system is an investigational device and not available for sale, advised Boston Scientific.