Medtronic plc and Irvine, Calif.-based Axonics Inc. have been locked in a struggle over several patents in the past few years, but now Medtronic has shifted some of its effort from the U.S. courts to the executive branch.
On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.
The U.K.’s National Institute for Health and Care Excellence (NICE) has given people looking to lose weight another treatment option by recommending endoscopic sleeve gastroplasty (ESG) as a therapy to help treat obesity. The move comes amidst increasing awareness of the disease brought on by the growing prevalence of GLP-1 agonists.
The Versavue single-use flexible cystoscope, recently launched by Boston Scientific Corp. in the U.S., could help reduce the risk of infections in patients that comes from the improper reprocessing of reusable cystoscopes, Ron Morton, Boston Scientific chief medical officer, Urology told BioWorld.
Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy.
Abbott Laboratories received U.S. FDA approval for its Liberta RC deep brain stimulation (DBS) system for use in movement disorders, less than two weeks after the agency gave its nod to Medtronic’s Percept RC DBS system. The news come on the heels of Abbott’s release of strong fourth quarter results on Wednesday.
Sichuan Jinjiang Electronic Medical Device Technology Co. Ltd. received approval from China’s National Medical Products Administration (NMPA) approval for the commercial use of its PFA technology in the treatment of atrial fibrillation, making it the first pulsed field ablation device to gain approval in the country.
Medtronic plc received the greenlight from the U.S. FDA for its latest deep brain stimulation system, the Percept RC. The rechargeable neurostimulator includes the company’s sensing technology which captures data from brain signals and allows for more personalized therapy.
Boston Scientific Corp. agreed to acquire neurostimulation company Axonics Inc. for $71 per share or $3.7 billion in total. Axonics focuses on stimulation of the sacral neve to treat overactive bladder and bowel dysfunction. It also offers a bulking agent to address stress urinary incontinence in women.
The deal is expected to close in the first half of 2024, pending approval of stockholders and regulators.
