LeMaitre Vascular (NSDQ:LMAT) recently issued an urgent field safety notice for some of its Syntel Silicone over-the-wire embolectomy catheters. The Burlington, Massachusetts-based company issued the warning due to the French size next to the outside diameter symbol on the label not reflecting the 5 Fr catheter extrusion used on all models of … [Read more...] about LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
Catheters
Gore voluntarily recalls some balloon catheters
W.L. Gore and Associates recently announced the voluntary product recall of its Molding and Occlusion Balloon (MOB) Catheters. The Newark, Delaware-based manufacturing company issued the warning due to complaints of leakage from the guidewire lumen and the y-hub during the preparation or use of the MOB catheters. The issue could result in … [Read more...] about Gore voluntarily recalls some balloon catheters
Penumbra launches RED reperfusion catheters in Europe
Penumbra (NYSE:PEN) announced today that it received the CE mark for its Penumbra RED reperfusion catheter and began the European launch. Alameda, California-based Penumbra designed its RED reperfusion catheter for the removal of all clot types in acute ischemic stroke (AIS) patients. The catheters are part of the Penumbra System — a fully … [Read more...] about Penumbra launches RED reperfusion catheters in Europe
Medtronic warns on Prevail Paclitaxel-coated PTCA balloon catheter
Medtronic this week issues an urgent field safety notice for some of its Prevail Paclitaxel-coated PTCA balloon catheters. The Fridley, Minnesota-based company issued the warning due to the potential for an incorrect compliance chart attached to the catheter hoop. The balloon size on the compliance chart differed from the balloon size detailed … [Read more...] about Medtronic warns on Prevail Paclitaxel-coated PTCA balloon catheter
J&J’s Biosense Webster launches mapping catheter for cardiac arrhythmias
Johnson & Johnson's Biosense Webster announced today that it launched the Octaray mapping catheter with TRUEref technology. Irvine, California-based Biosense Webster designed Octaray for mapping cardiac arrhythmias, including AFib. It is powered by the company's Carto 3 Version 7 system. The catheter has eight splines with improved … [Read more...] about J&J’s Biosense Webster launches mapping catheter for cardiac arrhythmias
Data backs Penumbra’s catheters for stroke care
Penumbra (NYSE:PEN) announced today that initial data support the use of its RED reperfusion catheters and the Penumbra System. Alameda, California-based Penumbra presented results from the initial Insight Registry for the RED reperfusion catheters and the sub-analyses of the Complete study for the Penumbra system at the 2022 World Federation of … [Read more...] about Data backs Penumbra’s catheters for stroke care
Medtronic launches Onyx Frontier drug-eluting stent
Medtronic (NYSE:MDT) today launched its newest drug-eluting coronary stent, Onyx Frontier. The Fridley, Minnesota-based company designed the Onyx Frontier drug-eluting stent (DES) to build upon its Resolute Onyx DES. It uses the same stent platform as the Resolute Onyx and has an enhanced delivery system to increase acute performance in … [Read more...] about Medtronic launches Onyx Frontier drug-eluting stent
Imagin Medical acquires Trod Medical’s enCage Coil precision ablation system
Imagin Medical this week announced it has acquired Trod Medical's enCage Coil precision ablation system. The company will acquire the enCage Coil for $2.5 million, which will be paid over time once certain developmental milestones are met. There will be an initial payment on the closing of $350,000 and $150,000 of Imagin shares. Of the initial … [Read more...] about Imagin Medical acquires Trod Medical’s enCage Coil precision ablation system
BD initiates first-in-human trial of sirolimus drug-coated balloon
BD today announced it started enrollment in the first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB). The Prevision trial is a prospective, multi-center, single-arm, non-randomized study that will evaluate the safety of BD's DCB in the treatment of peripheral arterial disease (PAD) in the femoropopliteal arteries. The company … [Read more...] about BD initiates first-in-human trial of sirolimus drug-coated balloon
The 24 best medical device innovations of 2022
The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products … [Read more...] about The 24 best medical device innovations of 2022