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
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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
Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
Abbott today announced new milstones supporting its suite of pulsed field ablation (PFA) solutions in electrophysiology. The company completed enrollment early for its VOLT-AF FDA investigational device exemption (IDE) study evaluating the Volt PFA system. It also launched its FOCALFLEX trial to assess its TactiFlex duo ablation catheter, … [Read more...] about Abbott progresses pulsed field ablation studies, launches cardiac mapping tool
Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
Experts from Medtech Big 100 device developers — Medtronic, Johnson & Johnson MedTech, Abbott and Boston Scientific — discuss the various shapes of their pulsed field ablation (PFA) catheters. From flowers and loops to globes, baskets and balloons, there's no standard shape for the pulsed field ablation (PFA) catheters coming out of Medtronic, … [Read more...] about Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott announced today that the FDA approved its Espirit everolimus-eluting resorbable scaffold system. The Espirit scaffold 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 completely dissolving. Abbott says that before … [Read more...] about Abbott wins FDA approval for dissolving drug-eluting scaffold
The top catheter-based innovation news stories of 2024 — so far
Catheter innovations have had a remarkable year so far, with many receiving regulatory approval as they prepare to enter the market. The pulsed field ablation market heated up in 2023 and continues to make waves this year with more companies entering the space. Intravascular lithotripsy is having its moment as well – Shockwave Medical was … [Read more...] about The top catheter-based innovation news stories of 2024 — so far
Nitinol grips prevent slips in Abbott’s heart valve clips
Nitinol is a key material in the heart valve clips that Abbott designed for its TriClip and MitraClip transcatheter edge-to-edge repair (TEER) systems. Abbott designed the TriClip system (approved by the FDA in April 2024) for reducing tricuspid valve regurgitation using fourth-generation heart valve clips that Abbott originally developed for … [Read more...] about Nitinol grips prevent slips in Abbott’s heart valve clips
How Abbott created its next-gen RF ablation system
For Abbott, combining two innovations into one AFib-treating system required manufacturing fine-tuning. The project’s R&D director explains. Pulsed field ablation (PFA) has generated a great deal of buzz for its potential to reduce complications in procedures for treating atrial fibrillation (AFib). But even as Abbott is developing its Volt … [Read more...] about How Abbott created its next-gen RF ablation system
Abbott is launching its latest Navitor TAVI system in the U.S.
Abbott (NYSE:ABT) is launching the latest generation of its Navitor heart valve technology in the U.S., according to one company official. In a post on LinkedIn, Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), shared the news of the launch. The latest version — called the Navitor Vision — features a range of … [Read more...] about Abbott is launching its latest Navitor TAVI system in the U.S.