Transcatheter Implant Expands Aortic Stenosis Treatment Options

A latest-generation transcatheter aortic valve implant (TAVI) system boasts design features designed to reduce or eliminate paravalvular leak (PVL) risk.

The Abbott Laboratories (Abbot Park, IL, USA) Navitor ia a self-expanding non-tapered stent with intra-annular leaflets and large frame cells that are designed to help improve access to critical coronary arteries. Large effective orifice areas (EOAs) result in single-digit gradients that improve cardiac function, long-term durability, and minimal prosthesis-patient mismatch. Navitor features the NaviSeal Cuff, which synchronizes to the cardiac cycle, seals, and mitigates PVL by expanding to fill calcification-related gaps between the annulus and the valve.

The Navitor device is implanted with Abbott's FlexNav delivery system, which offers a slim design with the lowest TAVI delivery system profile, allowing treatment of people with vessels as small as 5.0 mm. The slim catheter can accommodate different aortic anatomies, providing stable, predictable, and accurate valve delivery, placement, repositioning, and retrievability. An atraumatic nosecone and smooth transitions are designed to reduce vascular complications and prevent calcium dislodgement.

“The innovative design of the Navitor valve, paired with the FlexNav delivery system streamlines and simplifies TAVI procedures for physicians, enabling better valve placement and performance for patients so they can get back to living fuller, healthier lives,” said Michael Dale, senior vice president of Abbott's structural heart business. “The non-surgical Navitor TAVI system offers best-in-class deliverability and access through small vessels, expanding treatment options for patients with severe aortic stenosis.”

“With an aging world population and with aortic stenosis cases projected to double in Europe and the U.S. in the next few decades, the need for innovative, minimally invasive solutions is critical,” said Professor Lars Søndergaard, MD, of Rigshospitalet (Copenhagen Denmark). “While transcatheter valve replacement has for some time been a standard of care for patients with a narrowing of the aortic valve, Navitor helps to address challenges we sometimes find in current TAVI systems when we encounter complex patient anatomies that can lead to potential complications.”

Aortic stenosis restricts blood flow through the aortic heart valve to the rest of the body, which can lead to heart failure and, in certain cases, sudden cardiac death. (SCD) Treatment options include open-heart surgery, a high-risk procedure due to the potential complications stemming from age, frailty, or multiple co-morbidities. TAVI serves as a less invasive alternative to surgical aortic valve replacement and can reduce symptoms and improve the lives of patients with this debilitating condition.