Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance.
The Danish-German Cardiogenic Shock trial found that men implanted with Johnson & Johnson’s Impella CP after experiencing a heart attack with cardiogenic shock gain 600 days of life, on average, compared to usual care at 10 years. The study demonstrated no benefit for women.
Edwards Lifesciences Corp. execs no doubt danced a little jig on the release of the latest European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines for valvular heart disease. The update established a simplified pathway for severe aortic stenosis (AS) that eliminated the previous divide between symptomatic and asymptomatic severe AS.
Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery.
Billiontoone Inc.’s Northstar Select comprehensive genomic profiling liquid biopsy assay identified more treatable variants than other tumor profiling platforms in a study published in The Journal of Liquid Biopsy. Notably, the test found clinically actionable alterations substantially below the limit of detection for other tests.
The 50 million Europeans with peripheral artery disease have a new treatment option thanks to help restore blood flow to vessels below the knee now that Abbott Laboratories' Esprit BTK everolimus-eluting resorbable scaffold system has received CE mark. The stent, made of a material similar to dissolvable sutures, dissolves within three years.
After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. quickly returned to buy the organ preservation company. On Aug. 25, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.
Aclarion Inc.'s Nociscan, an AI-augmented platform that leverages MR spectroscopy to noninvasively identify the discs causing low-back pain, enables precise targeting of surgical intervention, resulting in 97% success. That’s roughly double the rate of 48% to 54% seen in conventional procedures for discogenic lower back pain, Aclarion CEO Brent Ness told BioWorld.
Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
Cohesys Inc. conducted the first test of its resorbable Bonetape in humans as part of an investigational trial for craniofacial fractures. The tape could eliminate the use of drills and screws in many plastic and reconstructive facial surgeries, potentially simplifying procedures and recovery.
