MiRus announced that it launched a U.S. multi-center early feasibility study for its Siegel transcatheter heart valve (THV). Dr. Pradeep K. Yadav and Dr. Vinod H. Thourani successfully performed the first two cases with the 8-Fr aortic THV. Both patients were discharged from Piedmont Heart Institute (Atlanta) without complications the next day. The latest development […]
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MiRus has positive first-in-human TAVR data
MiRus today announced positive first-in-human study results for its Siegel 8-Fr transcatheter aortic valve replacement (TAVR) system. Dr. Pradeep K. Yadav, director of structural interventions at Atlanta’s Piedmont Heart Institute, presented data at the New York Valves Conference. Five patients with severe, symptomatic aortic stenosis (AS) received treatment at the Instituto Nacional Del Torax in Santiago, […]
FDA clears MiRus expandable lumbar system
MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody. Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in PLIF and TLIF procedures. It has a low insertion profile at 4 mm, an expansion of 18 mm and a 24º lordosis. Get the full story on our sister […]
MiRus more than doubles plant size with Georgia facility buy
MiRus said yesterday that it’s more than doubling its manufacturing capacity with the acquisition of a plant in its hometown. The Marietta, Ga.-based company said the acquisition adds 50,000 sq.ft. to its existing 20,000-sq.-ft. facility. The new plant is a fully operational, 50,000-sq.-ft. orthopedic and spine manufacturing facility, MiRus said. Get the full story on […]
FDA clears first molybdenum rhenium pedicle screw
The FDA today cleared Mirus‘s Europea pedicle screw system, which is composed of its MoRe proprietary molybdenum rhenium superalloy, making it the first such device approved with the new class of implant material. The Atlanta-based medical device company said that the MoRe proprietary alloy is intended to provide improved strength, ductility, durability and biological safety. […]