Two years after the U.S. FDA approved the first pulsed field ablation system, Abbott Laboratories finally got the regulatory nod for its Volt PFA system. Abbott follows Medtronic plc, Boston Scientific Corp., Johnson & Johnson and Kardium Inc. in receiving approval for its approval for use of its PFA device to treat atrial fibrillation.
Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.
Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.
Boston Scientific Corp. continues to prove out its strategy of active acquisitions combined with industry-leading organic growth with the closing of its $88 million acquisition of Elutia Inc.’s Bioenvelope business and very positive targets for growth presented during its investor day on Sept. 30.
Medtronic plc posted nearly 50% year-over-year growth in its cardiac ablation business this quarter, with a 72% increase in revenue in the U.S., largely driven by pulsed field ablation. With significant opportunity in renal denervation and a new committee to look at growth including M&A and divestitures and another to review operations, analysts think the company stands a good chance of shedding its “chronic underperformer” image.
Johnson & Johnson beat analysts’ expectations for its second quarter results, led by medical device sales of $8.54 billion. All med-tech segments performed better than anticipated, with cardiology reporting exceptionally strong 22.3% growth. In addition, the innovative medicines division shocked the Street with 4.9% growth, despite the loss of patent protection for the blockbuster drug, Stelara.
Johnson & Johnson beat analysts’ expectations for its second quarter results, led by medical device sales of $8.54 billion. All med-tech segments performed better than anticipated, with cardiology reporting exceptionally strong 22.3% growth. In addition, the innovative medicines division shocked the Street with 4.9% growth, despite the loss of patent protection for the blockbuster drug, Stelara.
The U.K.’s National Institute for Health and Care Excellence (NICE) recommends the use of pulsed field ablation as an option to treat NHS patients with atrial fibrillation. NICE said evidence shows the procedure reduces atrial fibrillation and its symptoms, increases quality of life in the short term and raises no major safety concerns.
Boston Scientific Corp. gained a second U.S. FDA approval for its Farapulse pulsed field ablation catheter, expanding its use into drug-refractory, symptomatic persistent atrial fibrillation (AF) in addition to its existing approval for paroxysmal AF. The expanded indication marks the first of several regulatory approvals the company expects in the coming months.
Field Medical Inc. continues to reap funding from investors for its pulsed field ablation (PFA) system with a $35 million oversubscribed series B financing round. With treatment of atrial fibrillation already upended by PFA technology, Field sees ventricular tachycardia as a fertile new territory for transformation.
