Acist Medical Systems said today that it’s launching its RXi Mini fractional flow reserve device after winning 510(k) clearance from the FDA last summer. “Acist is excited about the additional value and flexibility that the RXi Mini will provide the cath lab,” president & CEO Brad Fox said in prepared remarks. “This next-generation FFR solution reflects […]
ACIST Medical Systems
EuroPCR 2017 Roundup: Boston Scientific’s Lotus beats Medtronic’s CoreValve in head-to-head study
Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial. Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with […]
HLT launches feasibility trial for Meridian TAVR
HLT said today that it launched a feasibility trial of its Meridian TAVR in a high-risk patient cohort. Maple Grove, Minn.-based HLT said the 20-patient Radiant study is a prospective, non-randomized, single-arm trial with an endpoint of all-cause mortality at 30 days. Follow-up is slated for 1, 5 and 12 months after implantation, and then annually to 5 […]
ACIST launches FFR trial
Interventional and diagnostic tech company ACIST said today it enrolled the 1st patient in a study of catheter-based interrogation and standard fractional flow reserve measurement. The study, slated to enroll 240 patients, is intended to investigate the measurement accuracy and incident of drift and device success using ACIST’s Navvus Rapid Exchange FFR microcatheter. “As with […]