Abbott announced late-breaking data for its next-generation Navitor transcatheter aortic valve implantation system. Results from the study supported Navitor’s recent U.S. Food and Drug Administration approval to treat people with severe, symptomatic aortic stenosis who are at high or greater risk for open-heart surgery.
The company also showcased late-breaking data for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder that continue to highlight the benefits of this device’s immediate and complete closure of the LAA – a differentiator from competing therapies – for patients with atrial fibrillation at risk of stroke.
The results of both studies were presented during late-breaking presentations at the annual Cardiovascular Research Technologies (CRT) meeting held in Washington, D.C. The findings reinforce the importance of continued advancements in minimally invasive technology that offer hope to patients with debilitating heart conditions.
New Results Highlight the Benefits of Navitor TAVI System
Following the development of Abbott’s next-generation TAVI system, the company launched the PORTICO NG (Next Generation) study; a prospective, multi-center, international, single-arm trial that supported the recent FDA approval of the Navitor TAVI system. Navitor features an active sealing cuff to reduce or eliminate the backflow of blood around the valve (paravalvular leak, or PVL), a known challenge with early generation TAVI devices. Based on the results from that study, Navitor was found to be a safe and effective treatment option for patients with severe, symptomatic aortic stenosis who are at high or greater surgical risk.
In the PORTICO NG study, Navitor was found to offer:
- High rate of procedural success (97%)
- Low rate of all-cause mortality (1.9%) and disabling stroke (1.9%) at 30 days
- Excellent PVL results, including 0% moderate or greater PVL at 30 days, demonstrating effectiveness of the NaviSeal™ active sealing cuff
“Abbott’s Navitor device offers a minimally invasive treatment option for severe aortic stenosis that can be lifesaving,” said Michael Reardon, M.D., Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, who served as principal investigator for the study that led to FDA approval of Navitor.
SOURCE: PR Newswire