European regulators for the 1st time approved a medical device for transcatheter valve-in-valve treatment in patients with degenerated surgical aortic valves, granting CE Mark approval to medtech titan Medtronic (NYSE:MDT) for its CoreValve and CoreValve Evolut devices.
Structural Heart
EuroPCR: New data showing reduced mortality in InspireMD’s MGuard stent trial
InspireMD (OTC:NSPR) presented new 6-month follow up data for its MASTER trial showing lower mortality rates in patients treated with its MGuard stent. The company’s findings were presented today at the STEMI symposium of the annual EuroPCR meeting in Paris, France.
The trial measured all-cause mortality for patients treated with the company’s MGuard stents compared to a control group treated with bare metal stents or drug-eluting stents.
EuroPCR: 1-year results continue to support Edwards’ next-gen Sapien XT valve
EuroPCR: Boston Scientific’s Lotus TAVI bests rivals with less leakage
Massachusetts-based medical device titan Boston Scientific (NYSE:BSX) released early data from a study of its Lotus transcatheter aortic valve implantation system, highlighting very low rates of paravalvular leakage that analysts said could give the company some leverage in the highly charged TAVI market.
EuroPCR: Medtronic’s CoreValve is a cost-effective option, U.K. researchers say
The latest update from Medtronic’s (NYSE:MDT) ADVANCE registry of patients treated with the CoreValve transcatheter aortic valve implantation evaluated the technology from a cost perspective, with researchers reporting that CoreValve is worth the money for patients with severe aortic stenosis.
Abbott touts CE Mark for “world’s longest” coronary DES
Stentys enrolls 1st patient in U.S. stent trial
Stentys SA (EPA:STNT) hoping a new U.S. clinical trial will help it win pre-market approval for a self-apposing coronary stent.
The Princeton, N.J.- and Paris-based medical device company said it enrolled the 1st patient in its Apposition V trial, under an investigational device exemption from the U.S. watchdog agency.
Claret Medical’s filter thwarts debris headed for the brain in TAVI patients, study shows
Claret Medical’s Montage Dual Filter system is poised to become a staple of transcatheter aortic valve implantation procedures if the company has anything to say about it.
In an original manuscript published by researcher Dr. Nicolas Van Mieghem he concluded that the Montage device captured "embolic debris" traveling to the brain in 75% of patients undergoing TAVI.
Biosensors International wins CE Mark for latest line of drug-eluting stents
Biosensors International (PINK:BSNRY) said it won a green light from European regulators for its BioMatrix NeoFlex drug-eluting stent, the latest in its DES line.
Tryton Medical launches side-branch stent in Europe
UPDATED May 17, 2013 with comment from Tryton CEO Shawn McCarthy.
Tryton Medical said it got the green light in Europe for its side-branch short coronary stent to treat bifurcation lesions in large vessels.
The new stent is 15mm, 3mm shorter in the main branch zone than the standard Tryton side-branch stent, the Durham, N.C.-based medical device company said.
Direct Flow Medical wins FDA approval for U.S. trial of new heart valve
The FDA granted Direct Flow Medical an investigational device exemption for its transcatheter aortic valve implant, with the medical device company announcing enrollment in its Salus feasibility trial.