HLT announced today that it received FDA approval for two clinical studies for its HLT Meridian transcatheter aortic valve replacement (TAVR) system. Maple Grove, Minnesota-based HLT, a Bracco Group Company, will conduct the studies to assess the performance of the HLT Meridian TAVR system in treating aortic stenosis and aortic regurgitation among high-risk patients suffering […]
HLT
7 medtech stories we missed this week: June 9, 2017
From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal 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 […]