Tag Archives: Cleared

Abbott’s FlexNav Cleared in EU to Deliver Portico Transcatheter Aortic Valve

March 6th, 2020 Cici Zhou Cardiac Surgery, Cardiology, Radiology Abbott announced that it received the EU CE Mark for the new FlexNav delivery system for the company’s Portico transcatheter aortic valve. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for patients diagnosed with aortic stenosis, a condition which restricts blood flow through the… Read More »

Omega FluoroShield FDA Cleared to Reduce Radiation Exposure

Omega Medical Imaging, a firm based in Sanford, Florida, has won FDA clearance for its FluoroShield technology, as well as the 2020 Cardiac Flat Panel Detector. FluoroShield automatically aims the radiation beam across the area of interest during interventional procedures utilizing fluoro or cine (short X-ray movies of the beating heart) imaging. This is thanks… Read More »

CanGaroo Envelope Now Cleared in U.S. to Protect Implantable Neurostimulators

Aziyo Biologics, out of Silver Springs, Maryland, won FDA clearance for its CanGaroo Envelope to be used with implantable neurostimulators. It has previously been cleared only for encapsulating implantable cardiac devices such as pacemakers and defibrillators. The CanGaroo Envelope is, contrary to what its name may imply, is a porcine extracellular matrix, essentially pig’s tissue with… Read More »