Abbott Laboratories landed CE mark for two versions of its Assert-IQ insertable cardiac monitor (ICM), one with a three-year battery life, the other lasting six years. Designed for long-term remote monitoring of individuals with abnormal heartbeats or at risk of developing arrhythmias, the device helps detect often-fleeting irregularities in heart rhythm to assist in diagnosis and care management.
Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can be activated by the patient with a remote control, will be able to improve the quality of life of the millions of people suffering from urinary incontinence.
Haemonetics Corp. appears ready to make a bit of a retro investment, as it entered into a definitive agreement to acquire Advanced Cooling Therapy Inc. (dba Attune Medical) for $160 million at closing plus undisclosed additional contingent payments. Attune manufactures the U.S. FDA-cleared Ensoetm device, which cools the esophagus during radiofrequency cardiac ablation procedures, a treatment for atrial fibrillation whose days appeared numbered.
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.