Abbott has taken a step forward in the development of a new addition to its structural heart portfolio, completing the first patient procedures with a yet-unnamed transcatheter aortic valve replacement system.
The new balloon-expanded heart valve is set to complement Abbott’s self-expandable Navitor TAVR implant, the company said, which received an FDA approval for its latest generation in early 2023. Both are designed to tackle severe aortic stenosis.
In addition, Abbott said the balloon-expandable valve—or one that is pushed open and unfolded by an inflatable catheter once it is threaded into position within the heart—will also serve as a foundation for artificial-intelligence-powered software that aims to ensure the implant’s correct placement during a procedure.
While balloon-expanded and self-expanding valves have been seen as interchangeable in some cases, they can offer trade-offs in the difficulty of the deployment procedure and how they interact with the patient’s anatomy. For example, while balloon-driven valves may be easier to implant, they are associated with higher risks when replacing heavily calcified valves.
Currently, the two most commonly used TAVR implants in the U.S. are Edwards Lifesciences’ balloon-expanded Sapien family and Medtronic’s self-expanding Evolut line.
“Transcatheter aortic valve implantation treatment has benefitted both physicians and patients over the years, but physicians have come to understand one device does not fit all their patients with aortic stenosis,” Azeem Latib, M.D., director of interventional cardiology and structural heart interventions at Montefiore Health System, said in a company statement.
Latib conducted the first-in-human procedures with Abbott’s valve at the Republican Centre of Emergency Medicine in Tashkent, Uzbekistan, alongside Vinayak Bapat, M.D., chair of cardiothoracic surgery at the Minneapolis Heart Institute, and in collaboration with the site’s principal investigator, Saidamir Djafarov.
Earlier this year, at the annual meeting of the American College of Cardiology in Atlanta, Medtronic put forward head-to-head data comparing its Evolut to Edwards’ Sapien among patients with a relatively small aortic annulus, a population that primarily includes women.
Patients that tend to have smaller heart valves and a tighter gap where the organ connects to the outgoing aorta have also seen additional complications after a TAVR procedure.
After one year, Medtronic’s system was shown to perform on par with Edwards’ in terms of composite rates tallying patient deaths, disabling strokes or rehospitalizations. However, Evolut’s self-expanding structure delivered superior results in measures of valve function; Medtronic has said its approach allows its valve to conform to the shape of the patient’s aortic ring and apply even outward pressure once it’s in place.
Medtronic has also estimated that 40% of all TAVR patients worldwide may have a small aortic annulus, as well as about 35% of the patients that have received a Sapien valve in the U.S.
Two months later, Edwards responded with retrospective, five-year data showing similar safety rates for its valve, regardless of the size of a patient’s annulus or their sex. Valve durability rates were also similar between patients with small versus large annuli, the company said.