Boston Scientific is touting results of a clinical study evaluating its ACURATE neo2 prosthetic aortic valve system. The implant and delivery system, which are not yet available for sale, had “a high procedural success rate and a low rate of paravalvular aortic regurgitation,” which is blood leaking around the valve, a month after implantation, according to the company.
In the ACURATE neo2 CE-Mark Study 97% of patients had mild to no paravalvular aortic regurgitation. Also, in 97% of cases the placement of the valve was rated as a success and doctors have reported quick installation times and few complications.
Some of the findings, according to Boston Sci:
· All-cause mortality rate was 3.3%; disabling stroke was 1.7%.
· Approximately 97% of patients had mild or less PVL, 3% had moderate PVL and no cases of greater
than moderate PVL were observed.
· Procedural data showed a high procedural success rate of 97.5% with a very short average device
usage time of 3.9 minutes. [i]
· Patients experienced marked hemodynamic improvement with the mean pressure gradients and
effective orifice areas (EOA), measures used to assess the hemodynamic performance of the valve,
were 7.9 +/- 3.2mmHg and 1.7 cm 2 , respectively.
Here’s animation showing the implantation procedure and highlighting the benefits of the new valve’s design:
Product page: ACURATE neo Aortic Valve…
Via: Boston Scientific…
