Timing is everything. Just days after confirming a pause in the U.S. rollout of its Varipulse pulsed field ablation (PFA) catheter, Johnson & Johnson’s electrophysiology program received an epic reprieve from European regulators who granted the company’s dual-energy Thermacool Smarttouch SF catheter CE mark.
Johnson & Johnson halted the limited rollout of its Varipulse pulsed field ablation system on Jan. 5 to “investigate the root causes of four reported neurovascular events in the U.S. external evaluation.” So far, just 130 cases have been completed in the U.S. since the company received U.S. FDA approval in November for use in paroxysmal atrial fibrillation.
With more than 60 acquisitions completed in the last decade, Stryker Corp. shows little fear in committing to offers that allow it to obtain the companies and technologies that have driven its impressive growth in stock price – up from $92 in Jan. 2015 to $356.70 in Jan. 2025. Still, the definitive agreement to buy Inari Medical Inc. for $4.9 billion comes in at the upper range, along with the $4 billion acquisition of Wright Medical Group NV in 2020 ($5.4 billion with debt included), $3 billion for Vocera Communications in 2022, and $2.8 billion for Sage Products in 2016.
The U.K. government will unveil its 10-year health plan to transform the national health service (NHS) in the coming months. At the center of this transformation is expected to be the adoption of artificial intelligence, digital and medical technologies. However, challenges in the NHS around its ‘core technology’, data capture and interoperability must be addressed before the government’s ambition can be realized.
The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.
The force is with Field Medical Inc. as it celebrates the U.S. FDA’s decisions to grant breakthrough device designation (BDD) to its Fieldforce ablation system and to accept it into the agency’s Total Product Life Cycle Advisory Program pilot. Field Medical designed the Fieldforce pulsed field ablation catheter specifically to treat ventricular tachycardia. The BDD applies to its use in monomorphic scar-related VT.
Three years after the U.S. FDA approval of Abbott Laboratories’ Amplatzer Amulet, results of its investigational device exemption trial failed to notably differentiate Abbott’s left atrial appendage occluder system from Boston Scientific Corp.’s market-dominant Watchman device beyond the ability to forego anticoagulants quickly after implantation.
Boston Scientific Corp.’s OPTION study demonstrated left atrial appendage closure with the Watchman Flx device reduced risk of stroke compared to management with direct oral anticoagulants or warfarin in patients with atrial fibrillation following cardiac ablation. Results were presented at the American Heart Association's Scientific Sessions 2024 and simultaneously published in The New England Journal of Medicine.
Boston Scientific Corp. resumed enrollment in the AVANT GUARD trial of the Farapulse pulse field ablation (PFA) system after a pause reported in October “to assess a few unanticipated observations.” The trial aims to expand the indications for the market-leading PFA system to include a new population, drug-naïve patients with persistent atrial fibrillation.
Almost a year after U.S. FDA approval of the first pulsed field ablation device for treatment of atrial fibrillation, Johnson & Johnson secured FDA approval for its Varipulse system, intensifying competition in the rapidly growing market.
