September 13, 2018 Source: drugdu 371
Boston Scientific’s ACURATE neo2 prosthetic aortic valve system witnessed an “a high procedural success rate and a low rate of paravalvular aortic regurgitation (leakage of blood near the valve),” after being implanted for a month in a clinical study. The company is publicizing the findings of the study before it is made available in the market.
It was observed that 97% of individuals showed no or little paravalvular aortic regurgitation and the positioning of the implant was quick and successful without any significant complications in the same percentage of patients registered in the ACURATE neo2 CE-Mark Study.
Moreover, the all-cause mortality rate in the study was found to be 3.3% and a disabling stroke was reported in 1.7% of the patients. Severe Paravalvular leak (PVL) was reported in none while mild or lesser PVL was noted in about 97% of patients and 3% reported moderate PVL.
Data pertaining to the implanting procedure displayed an excellent success rate of the procedure of about 97.5% with the average usage duration of the device of 3.9 minutes.
A significant improvement in the hemodynamics was noted in the patients’ by measuring the mean pressure gradients which were 7.9 +/- 3.2mmHg and effective orifice areas (EOA) which were measured as 1.7 cm2.
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