At the 2013 Cardiovascular Research Technologies (CRT) meeting, technological innovation for aortic valve disease assumed the spotlight. Presenters highlighted new developments in optimal delivery design for percutaneous valves.
Though Edwards Lifesciences’ Sapien Valve remains the only commercially approved transcatheter aortic valve replacement (TAVR) device in the U.S., 10 new devices are in the pipeline. Medtronic’s CoreValve is second closest to market. Whereas past CRT discussions have centered on TAVR’s safety and efficacy, debates this year focused on delivery mechanism, namely balloon- versus self-expandable devices.
Optimizing TAVR design: Balloon vs. self-expandable devices
With 2013 in full swing, we’ve taken a step back to review the major CV technology stories of 2012. From devices gaining FDA approval to therapies demonstrating paradigm-shifting potential, 2012 was a year of significant innovation across CV services. To help CV leaders nationwide distill the most impactful new research, data, and FDA approvals, we’ve broken down the four top stories of 2012 and what you need to know in 2013.
Top cardiovascular technology trends of 2012
Gaithersburg, MD- On Wednesday, June 13, the FDA's Circulatory Systems Devices Panel voted to recommend the Edwards SAPIEN transcatheter aortic valve for clinical approval in high-risk surgical aortic valve replacement candidates. Since November of 2011, SAPIEN has been approved for use only in patients deemed inoperable. However, if the FDA opts to heed the panel's recommendation for approval, the patient population eligible for SAPIEN will expand considerably.
FDA panel recommends clinical approval of SAPIEN TAVR device for high risk surgical aortic valve replacement candidates