May 19, 2023

May 19, 2023 Abbott (NYSE: ABT) + today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world’s first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely, according to the company. The result is a reduction in procedure times and improved safety compared with the company’s previous-generation ablation catheters. Abbott officials think their next-gen radiofrequency ablation system will enable more efficient and accurate arrhythmia treatments. “For those suffering from AFib, daily life can be challenging as people often feel dizziness, chest pain and heart palpitations. AFib can lead to stroke if left untreated, making it critical for physicians to treat the issue as early as possible,” said Dr. Larry A. Chinitz, director of the Heart Rhythm Center and co-director of NYU Langone Heart in New York City. “We are entering the next chapter of AFib ablation with new tools such as Abbott’s TactiFlex that, when used with mapping systems to accurately identify the source of an arrhythmia, can safely and efficiently treat the problem in ways we never thought possible a decade ago,” Chinitz said in a news release . Abbott wins approval for the next-gen RF ablation system amid an increasingly competitive cardiac ablation space. Competitors include Johnson & Johnson’s Biosense Webster, Medtronic, Boston Scientific, AtriCure, Acutus Medical and more. Excitement has grown over the potential of an alternative energy source — pulsed-field ablation — as well as systems that enable doctors to toggle between RF and PFA energy sources. To up its offerings in the RF ablation space, Abbott gave its TactiFlex Catheter a unique tip design that incorporates a laser-cut pattern that flexes upon contact with the heart wall, effectively directing fluid to the targeted tissue. This design improves the positioning accuracy of the catheter and delivers up to twice the stability in a beating heart, ensuring consistent and effective therapy. According to Abbott, the TactiFlex AF IDE study showed the catheter created fast, safe lesions to treat AFib with over 99% acute procedural success. “Abbott is leading the way in helping doctors manage common arrhythmias with the most holistic portfolio for this condition in the world,” said Dr. Christopher Piorkowski of Abbott’s electrophysiology business. “The EnSite X EP System is unmatched in determining the exact location where ablation is required. Coupled with the TactiFlex catheter, patients can now feel even more confident that their procedure will deliver safe and effective results.” Digital health startups are breaking ground with new medtech innovations in wearable devices, software, robotics and patient personalization. A wide range of digital technologies promise to increase the safety and effectiveness of patient care while lowering costs for healthcare providers still struggling with financial challenges from the COVID-19 pandemic. The world’s largest medical device developers… […] Medical device contract manufacturer Biomerics announced a deal to acquire the medical business of Precision Concepts. Salt Lake City-based Biomerics said yesterday it plans to buy the medical business and assets of Mooresville, North Carolina-based Precision Concepts International and Winston-Salem, North Carolina-based Precision Concepts Group. 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