ALung Technologies announced today that it received FDA de novo clearance for its Hemolung respiratory support platform. Pittsburgh-based ALung designed its Hemolung system to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) for patients with acute respiratory failure. Get the full story at our sister site, MassDevice. … [Read more...] about ALung Technologies wins FDA de novo nod for Hemolung respiratory assist system
Catheters
What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic (NYSE:MDT) continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. The hope now is to win FDA approval in 2023. To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason … [Read more...] about What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic reports promising early data for transfemoral delivery of its Intrepid TMVR
Medtronic (NYSE:MDT) this week touted data for its Intrepid self-expanding transcatheter mitral valve replacement (TMVR) system. Early data from 15 patients in an early feasibility study was presented as late-breaking clinical science at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the … [Read more...] about Medtronic reports promising early data for transfemoral delivery of its Intrepid TMVR
Edwards touts trial results for Evoque transcatheter tricuspid valve replacement system
Edwards Lifesciences (NYSE:EW) shared data from a clinical trial showing that its Evoque transcatheter tricuspid valve replacement offers favorable patient outcomes. Irvine, California–based Edwards presented the data during the late-breaking clinical science session at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), according to a … [Read more...] about Edwards touts trial results for Evoque transcatheter tricuspid valve replacement system
Alcon to acquire Ivantis for $475M
Alcon (NYSE:ALC) announced today that it intends to acquire glaucoma surgery device maker Ivantis for $475 million upfront. Geneva, Switzerland-based Alcon aims to bolster its portfolio across cataract, refractive, retina and glaucoma offerings by acquiring Ivantis and its novel Hydrus Microstent for minimally invasive glaucoma surgery … [Read more...] about Alcon to acquire Ivantis for $475M
Data shows safety and strong performance for Penumbra’s Indigo CAT RX catheter
Penumbra (NYSE:PEN) announced today that the Cheetah clinical study for its Indigo CAT RX catheter met its primary endpoint. Alameda, California-based Penumbra’s Indigo catheter system demonstrated high rates of blood clot removal, blood flow restoration and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in … [Read more...] about Data shows safety and strong performance for Penumbra’s Indigo CAT RX catheter
Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says
Edwards Lifesciences (NYSE:EW) today touted a cost-effectiveness analysis that supports transcatheter aortic valve replacement (TAVR) with the Sapien 3. Irvine, California-based Edwards presented data from the Partner 3 trial during the late-breaking clinical trials at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), the annual … [Read more...] about Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says
Medtronic touts 5-year study of self-expanding TAVR platform
Medtronic (NYSE:MDT) today presented five-year clinical data for its CoreValve and Evolut transcatheter aortic valve implantation (TAVI) platforms. Fridley, Minnesota-based Medtronic presented results from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial at the 33rd Transcatheter Cardiovascular Therapeutics … [Read more...] about Medtronic touts 5-year study of self-expanding TAVR platform
ReValve Solutions completes first successful procedure with TMVR system
ReValve Solutions announced this week that it completed the first human use of its transcatheter mitral valve replacement (TMVR) system. Bainbridge Island, Washington-based ReValve Solutions said in a news release that the first procedure with its Palmetto TMVR system was performed at the Italian Hospital in Asuncion, Paraguay, by Dr. Charles … [Read more...] about ReValve Solutions completes first successful procedure with TMVR system
Penumbra beats the Street in Q3, grows sales 25%
Penumbra (NYSE:PEN) posted third-quarter results this week that beat the overall consensus on Wall Street. The Alameda, California-based company reported profits of $8.85 million, or 24¢ per share, on sales of $190.1 million for the three months ended Sept. 30, for a sales growth of 25.84% compared with Q3 2020. Adjusted to exclude one-time … [Read more...] about Penumbra beats the Street in Q3, grows sales 25%