Stereotaxis (NYSE:STXS) has won FDA approval for its robotically navigated MAGiC ablation catheter, offering a minimally invasive option for patients who otherwise might not be eligible for cardiac ablation to treat complex and critical heart rhythm disorders. MAGiC is short for "magnetic interventional ablation catheter," an abbreviation … [Read more...] about Stereotaxis MAGiC cardiac ablation catheter wins FDA approval
Technologies & Devices
Gore wins FDA nod for deep venous stent
W.L. Gore & Associates announced today that the FDA approved its Viabahn Fortegra venous stent, formerly known as Viafort. The company touts Viabahn Fortegra as the first device for the treatment of deep venous disease in the inferior vena cava (IVC), iliac and iliofemoral veins. It marks the latest addition to the Viabahn device family, … [Read more...] about Gore wins FDA nod for deep venous stent
Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
Edwards Lifesciences [WtwhTicker symbol="EW"](NYSE: EW)[/WtwhTicker] has won FDA approval for its Sapien M3 mitral valve replacement system for treating mitral regurgitation (MR). The company said it's the first approval for a transcatheter MR therapy utilizing a transseptal approach. The approval came earlier than Edwards expected. The … [Read more...] about Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
Abbott earns FDA approval for Volt PFA system for AFib
Abbott (NYSE:ABT) announced today that the FDA approved its Volt pulsed field ablation (PFA) system to treat patients with AFib. The regulatory nod brings Abbott Volt to the U.S. PFA market to compete against the likes of Medtronic, Boston Scientific, Johnson & Johnson MedTech and Kardium. It follows CE mark approval for Volt earlier this … [Read more...] about Abbott earns FDA approval for Volt PFA system for AFib
12 things you need to know about the transcatheter heart valves market
Transcatheter heart valve repair and replacement have reshaped how structural heart disease is treated, and the market behind these technologies is evolving just as quickly. As valve design improves, delivery systems become more refined, and patient eligibility expands, transcatheter therapies are moving from niche alternatives to standard of … [Read more...] about 12 things you need to know about the transcatheter heart valves market
HRS launches data registry for PFA that treats AFib, J&J announces sponsorship
Johnson & Johnson MedTech today announced its sponsorship of a new PFA data collection platform from the Heart Rhythm Society (HRS). HRS aims to capture real-world data on pulsed field ablation (PFA) procedures used to treat AFib. The first-of-its-kind registry will offer a long-term data collection platform, J&J MedTech said in a news … [Read more...] about HRS launches data registry for PFA that treats AFib, J&J announces sponsorship
Medtronic, J&J MedTech both get FDA nods for liquid embolic systems
Medtronic (NYSE: MDT) and Johnson & Johnson (NYSE: JNJ) have both announced recent regulatory milestones for liquid embolic systems. Both picked up FDA approvals for the treatment of symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery. Earlier this month, Medtronic said the FDA granted the indication for its … [Read more...] about Medtronic, J&J MedTech both get FDA nods for liquid embolic systems
Abbott wins FDA clearance, CE mark for Amplatzer Piccolo delivery system
Abbott [WtwhTicker symbol="ABT"](NYSE: ABT)[/WtwhTicker] announced today that it received FDA clearance for its Amplatzer Piccolo delivery system for use with the Amplatzer Piccolo Occluder. Additionally, the system picked up CE mark for commercialization in Europe. The company designed its new delivery system specifically to treat premature … [Read more...] about Abbott wins FDA clearance, CE mark for Amplatzer Piccolo delivery system
Pulse Biosciences wins FDA IDE to study PFA tech
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted an investigational device exemption (IDE) for a pulsed field ablation (PFA) study. The IDE enables the Hayward, California–based company to initiate the NANOPULSE-AF study of its nPulse cardiac catheter ablation system. The study evaluates the company's PFA technology in the … [Read more...] about Pulse Biosciences wins FDA IDE to study PFA tech
Heart Failure Solutions system has first in-human use
Heart Failure Solutions, a clinical-stage medtech company based outside Minneapolis, recently announced the first successful in-human use of its PeriCut system, designed to treat patients with heart failure with preserved ejection fraction (HFpEF). The in-human use of the system was a part of Heart Failure Solutions’ FDA-approved early … [Read more...] about Heart Failure Solutions system has first in-human use
