Abbott Laboratories receives FDA approval for Navitor TAVR system

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Abbott Laboratories recently announced FDA approval for its transcatheter aortic valve replacement (TAVR) system, Navitor, for the treatment of severe aortic stenosis. Its unique features include a fabric cuff—the NaviSeal—to prevent paravalvular leak and a self-expanding leaflet system that allows easy access to the coronary vessels.

The Navitor system is not a new device to the global TAVR market, as it received CE approval in Europe in 2021. Considering the TAVR market’s aggressive growth over the years, it is no surprise that Abbott would want to break into the market and gain some market shares. In the US alone, the volume of TAVR devices sold between 2015 and 2019 experienced an aggressive compound annual growth rate of 37%, with sales reaching over $2bn in 2019.

In the past, Boston Scientific tried to break into the TAVR market with its Lotus Edge TAVR system. Unlike its more famous competitors, Edwards Lifesciences and Medtronic, Boston Scientific was unable to expand its market share to the low-risk patient population for aortic stenosis, ultimately leading to the company’s withdrawal from the market as a whole. This resulted in the duopoly that the TAVR market is today, with Edwards Lifesciences possessing 64% market share and Medtronic having 31%.

Navitor’s unique design may give it a competitive advantage over its two well-known competitors, as it is the first TAVR system to offer hemodynamics in all valve sizes and a self-expanding leaflet system. However, similar to Boston Scientific’s Lotus Edge, Navitor is only indicated for severe cases of aortic stenosis. When treating mild or intermediate cases, physicians are forced to seek other TAVR systems, such as Edwards Lifesciences’ Sapien or Medtronic’s Evolut system, that have a wider coverage of indications.

It would be extremely beneficial if the Navitor system received FDA approval for low-risk patients, in addition to its unique design. Perhaps this is something Abbott can investigate in the future. For now, Abbott certainly has an uphill battle, especially with Edwards Lifesciences possessing over 50% market share. Optimistically speaking, potentially Navitor’s unique design may be enough to push Abbott as a third major player in the TAVR market. Only time will tell if the Navitor will succeed in penetrating the market.

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• Source: https://www.medicaldevice-network.com/comment/abbott-fda-navitor/