Boston Scientific (NYSE:BSX) touted positive results from multiple studies for its Acurate neo2 aortic valve system.
Marlborough, Mass.-based Boston Scientific presented results from the investigator-initiated Early neo2 Registry and ITAL-neo Registry studies at the EuroPCR 2021 meeting earlier this week, according to a news release.
Results from the Early neo2 Registry of 554 patients across 12 European centers showed a 1.3% post-operative moderate/severe paravalvular leakage (PVL) rate, which was lower than the rate observed in previous studies of the device. Mild and none/trace PVL rates registered at 33.3% and 65.4%, respectively.
Meanwhile, the study revealed a 6% permanent pacemaker implementation (PPI) rate, a 2.1% in-hospital stroke rate, a 1.3% mortality rate at 30 days, as well as excellent hemodynamics, according to Boston Scientific. Results demonstrated that the Acurate neo2 device was associated with significantly less aortic regurgitation when compared to the prior-generation version of the device, the company said.
The ITAL-neo study of 95 transcatheter aortic valve implant (TAVI) patients from nine Italian centers evaluating in-hospital device success and in-hosptial patient outcomes observed 3.1% pre-discharge moderate/severe PVL rate. Along with the mild and none/trace PVL rates (56.9% and 40%, respectively), the trial registered lower than previously reported PVL compared to past studies of the device.
Additionally, Acurate neo2 registered a 97.9% success rate, 1.1% in-hospital stroke rate, 11.2% in-hospital new PPI rate and excellent hemodynamics, Boston Scientific said.
“These real-world findings reinforce the effectiveness of the Acurate neo2 valve design enhancements — including the 60% larger outer sealing skirt to conform to challenging anatomies — that have minimized PVL and shown excellent clinical outcomes in a broad spectrum of patients when compared to data collected with the previous-generation Acurate neo aortic valve system,” Boston Scientific global CMO Dr. Ian Meredith said in the release.
Positive results for the Acurate neo2 device follow last September’s announcement that the company initiated a controlled launch of the device across Europe after receiving CE mark approval in April 2020.
After the company initiated a global, voluntary recall of its Lotus Edge aortic valve system and retired the device in November 2020, Boston Scientific chairman & CEO Mike Mahoney said that Boston Scientific was turning its focus to the Acurate neo2 platform.
“We think Acurate neo2 is a different category of valve from Lotus and the customers who like Acurate are really enjoying [the next-generation] neo2,” Mahoney said months ago. “One of the benefits [of retiring Lotus] will be that it will allow us to focus on this platform.”
When UBS analysts listed Boston Scientific among its top stock picks for 2021 in December 2020, they cited the Acurate neo2 device as a driving factor behind growth for the company, too.