Stakeholders of all stripes have wondered whether transcatheter aortic valve replacement devices could match their surgically implanted cousins for device durability, but seven-year data from the Partner 3 trial seems to suggest that patients, physicians, payers and regulators need not fret as the topline numbers showed no statistically significant difference for outcomes such as mortality and morbidity.
Edwards Lifesciences Corp. fully acquired Vectorious Medical Technologies Ltd. for $497 million, following a series of investments in the heart failure technology company over the last five years.
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.
The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.
The U.S. Federal Trade Commission (FTC) reported Aug. 6 that it will try to block Edwards Lifesciences Corp.’s proposed acquisition of Jenavalve because Edwards’ acquisition of both Jenavalve Technology Inc. and JC Medical would eliminate competition in the TAVR space for aortic regurgitation.
The U.S. FDA noted in a series of Federal Register declarations that several device makers are working with the Patent and Trademark Office to claim regulatory review times for their devices, including the Sapien 3 Ultra Resilia device by Edwards Lifesciences Corp.
The final Medicare coverage memo for transcatheter edge-to-edge repair for tricuspid valve regurgitation largely replicates the April 2025 draft, but cardiology centers will not have to bring an electrophysiologist to the patient’s care team to be permitted to practice these devices.
Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies.
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.
