The FDA is now requiring labeling updates for all GLP-1 medications due to a risk of NAION, a rare eye condition that can result in sudden, permanent vision loss.
This represents the first randomized trial focused on treating moderate aortic stenosis with Medtronic's self-expanding, supra-annular Evolut platform.
Laza Medical, a California-based medtech company, is developing advanced technologies for the cath lab. GE HealthCare also participated in a previous financing round in 2023.
Delivery systems included in this recall should not be used to treat patients going forward. The FDA shared an early alert about the issue back in October.
Curtiss Stinis, MD, has been performing TAVR for nearly two decades. He says the new policies from CMS that expand coverage for asymptomatic patients represent a "momentous step forward" for heart patients with severe aortic stenosis.
