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
Abbott
Transcatheter heart valves market to enjoy solid growth
The global, multibillion-dollar transcatheter heart valves market will grow at an 8.4% CAGR over the rest of the decade, according to MassDevice's latest Medtech Market Intelligence Report. Minimally invasive therapies have gained traction in the management of structural heart disease, and the field continues to evolve. The most established … [Read more...] about Transcatheter heart valves market to enjoy solid growth
Abbott gets FDA breakthrough nod for dual-energy ablation catheter
An Abbott [WtwhTicker symbol="ABT"](NYSE: ABT)[/WtwhTicker] official posted on social media to announce FDA breakthrough device designation for a new ablation catheter. Abbott SVP Uri Yaron said on LinkedIn that the FDA granted the breakthrough nod for the TactiFlex Duo Sensor-Enabled catheter. The catheter features a dual-energy modality for the … [Read more...] about Abbott gets FDA breakthrough nod for dual-energy ablation catheter
Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage
The FDA today issued a notice warning of updated instructions for the Abbott (NYSE: ABT) TactiFlex Ablation Catheter, Sensor-Enabled (SE). According to the agency, Abbott issued a letter to affected customers recommending updated instructions when removing the catheter from its packaging. The communication comes as part of the FDA's Communications … [Read more...] about Abbott updates instructions for TactiFlex ablation catheter following instances of tip damage
Abbott reports first commercial Tendyne mitral valve implant in the U.S.
An Abbott official announced on social media that doctors completed the first commercial implant of Tendyne in the U.S. Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), posted the news on LinkedIn. It’s the latest milestone for Tendyne, a transcatheter mitral valve replacement (TMVR) system, after its FDA … [Read more...] about Abbott reports first commercial Tendyne mitral valve implant in the U.S.
Abbott wins CE mark for Esprit drug-eluting, dissolving scaffold
Abbott (NYSE: ABT) announced today that it received CE mark for its Esprit BTK everolimus-eluting resorbable scaffold system. Esprit BTK offers treatment for people with peripheral artery disease (PAD) below the knee (BTK). Abbott designed it to keep arteries open and deliver the drug everolimus to support vessel healing. Following the therapy, … [Read more...] about Abbott wins CE mark for Esprit drug-eluting, dissolving scaffold
New data supports Abbott Volt pulsed field ablation system
Abbott (NYSE:ABT) today announced new study data demonstrating the safety and efficacy of its Volt pulsed field ablation (PFA) system. The Volt CE Mark study evaluated Volt's safety and efficacy out to 12 months for treating AFib. Data highlighted the system's safety profile along with its ability to achieve results with fewer therapy … [Read more...] about New data supports Abbott Volt pulsed field ablation system
Abbott is making an IVL play with FDA IDE nod
Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system. IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to … [Read more...] about Abbott is making an IVL play with FDA IDE nod
Abbott reports first cases with software-guided balloon-expandable TAVI
Abbott (NYSE:ABT) today announced the first patient procedures with its investigational transcatheter aortic valve implantation (TAVI) system. The company designed its investigational software-guided, balloon-expandable TAVI system to build a foundation for AI-guided procedures. It hopes to add the expandable system to its structural heart … [Read more...] about Abbott reports first cases with software-guided balloon-expandable TAVI
Abbott reports sustained benefits with Esprit drug-eluting stent
Abbott (NYSE:ABT) today announced data demonstrating the long-term effectiveness of its Esprit BTK drug-eluting stent. The everolimus-eluting resorbable scaffold system treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to … [Read more...] about Abbott reports sustained benefits with Esprit drug-eluting stent
