Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.
While GLP-1 receptor agonists continue to grab the headlines as a treatment option for obesity, another therapy, endoscopic sleeve gastroplasty (ESG), is seeing a steady rise in demand.
Despite the advancement of AI and machine learning technologies and their incorporation into cancer treatment and drug development, a lack of trust and understanding of these new approaches is impeding care and treatment.
Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.
The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted in 2024 for use in inguinal hernia repair.
Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz were at a TR grade ‘none’ (0+) or ‘mild’ (1+) following the procedure.
Medtronic plc revealed data at the EuroPCR conference which showed there was a significant, safe and sustained blood pressure reduction in patients treated with its Spyral renal denervation system who meet European recommended guidelines criteria over a three-year period.
Three-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system continued to see lower adverse events rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent .