Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel–based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September. The leaflet modification system […]
Pi-Cardia
Pi-Cardia completes first-in-human mitral valve splitting with ShortCut
Pi-Cardia announced today that it completed a successful first-in-human treatment of the mitral valve with its ShortCut device. Rehovot, Israel-based Pi-Cardia designed ShortCut to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after transcatheter aortic valve replacement (TAVR) or left ventricular outflow tract (LVOT) obstruction after transcatheter mitral […]
Smith & Nephew taps ex-Roche chief Diggelman for CEO | Personnel Moves, October 21, 2019
Smith & Nephew (NYSE:SNN) today named former Roche (PINK:RHHBY) chief Roland Diggelmann to replace Namal Nawana next month. Nawana, named to succeed Olivier Bohuon last year, is stepping down effective Nov. 1 “to pursue other opportunities outside of the U.K.,” the London-based healthcare giant said. Nawana is slated to stay on until Dec. 31 to […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. […]
Pi-Cardia pulls in $10m for Leaflex aortic valve catheter
Stealthy Pi-Cardia said today that it raised $10 million from a consortium that includes a mystery strategic investor for its Leaflex treatment for aortic stenosis. Rehovot, Israel-based Pi-Cardia’s Leaflex is a catheter-based procedure designed to use mechanical energy to crack the calcification on aortic valve leaflets to return them to normal function. The company said […]
