Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter. The irrigated, contact-force sensing catheter features alongside the TruPulse generator. Both offer full integration with the Carto 3 electro-anatomical mapping … [Read more...] about Johnson & Johnson MedTech wins CE mark for dual-energy catheter
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Johnson & Johnson MedTech halts Varipulse cases due to stroke reports
Johnson & Johnson MedTech announced today that it "temporarily paused" all U.S. cases using its Varipulse pulsed field ablation (PFA) system as of Jan. 5. "Out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four … [Read more...] about Johnson & Johnson MedTech halts Varipulse cases due to stroke reports
Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
Johnson & Johnson MedTech announced today that the FDA approved its Varipulse pulsed field ablation (PFA) platform for treating AFib. Varipulse treats AFib with a single device that combines PFA with the Carto 3 mapping system. With approval, Johnson & Johnson joins Medtronic and Boston Scientific as companies with PFA technologies … [Read more...] about Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
Shockwave Medical’s Javelin IVL catheter meets primary trial endpoints
Johnson & Johnson MedTech's Shockwave Medical unit today announced the first clinical outcomes associated with its Javelin catheter. Shockwave shared the first clinical outcomes associated with its Javelin peripheral intravascular lithotripsy (IVL) catheter system. It designed this novel, non-balloon-based lithotripsy platform to modify … [Read more...] about Shockwave Medical’s Javelin IVL catheter meets primary trial endpoints
Johnson & Johnson completes pilot enrollment in Omnypulse trial
Johnson & Johnson MedTech today announced the completed enrollment of the pilot phase of a clinical trial for its Omnypulse platform. The OMNY-AF clinical trial evaluates the investigational platform for the treatment of symptomatic paroxysmal AFib in the U.S. and Australia. The single-arm, multi-center trial completed the pilot phase … [Read more...] about Johnson & Johnson completes pilot enrollment in Omnypulse trial
Johnson & Johnson reports first commercial Varipulse PFA use in Canada
Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] today announced the first completed commercial case with its Varipulse platform in Canada. The company said in a post on LinkedIn that doctors at the Ottawa Heart Institute completed the first commercial case with Varipulse. Johnson & Johnson said the procedure … [Read more...] about Johnson & Johnson reports first commercial Varipulse PFA use in Canada
J&J’s Shockwave adds enhanced catheter to U.S. IVL portfolio
Johnson & Johnson MedTech's Shockwave Medical today announced the full U.S. launch of its Shockwave E8 peripheral IVL catheter. Santa Clara, California-based Shockwave launched the intravascular lithotripsy (IVL) catheter following FDA clearance. It designed the catheter to optimize the treatment of patients with calcified femoro-popliteal … [Read more...] about J&J’s Shockwave adds enhanced catheter to U.S. IVL portfolio
J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial. The prospective, multi-center, non-randomized trial enrolled 188 patients in Europe and Canada. It evaluates the safety and effectiveness of the company's Omnypulse platform. The J&J unit designed … [Read more...] about J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
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
Biosense Webster reports positive dual-energy ablation results
Johnson & Johnson's Biosense Webster unit today announced positive three-month follow-up results from its SmartfIRE clinical trial. The study evaluated the use of the dual-energy ThermoCool SmartTouch SF catheter. ThermoCool SmartTouch SF is the first dual-energy pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated … [Read more...] about Biosense Webster reports positive dual-energy ablation results