Abbott Laboratories recently announced US FDA approval for its transcatheter aortic valve replacement (TAVR) system Navitor for the treatment of severe aortic stenosis. With the system, Abbott is attempting to enter the market that is difficult to penetrate as it is dominated by only two players, Edward’s Lifesciences and Medtronic, says GlobalData, a leading data and analytics company.

Historically, the TAVR market has been a booming medical device market due to physicians’ preferences for minimally invasive procedures. According to GlobalData, in the US alone, the volume of TAVR devices sold between 2015 and 2019 experienced an aggressive compound annual growth rate (CAGR) of 37%, with sales reaching over $2 billion in 2019 and over $3 billion in 2021. The aggressive growth in the TAVR market is largely spearheaded by Edward’s Lifesciences and Medtronic, which currently hold a market share of 64% and 31%, respectively.

Joselia Carlos, Medical Devices Analyst at GlobalData, comments: “As the treatable patient population becomes saturated, we predict that the number of TAVR procedures will eventually plateau in the distant future. Now is definitely the time to break into the market before the number of TAVR procedures plateaus. However, it is incredibly difficult for other companies to penetrate the market, given the dominance of Edward’s Lifesciences and Medtronic.”

In the past, there have been attempts to enter the TAVR market, but all these attempts were unsuccessful. For example, in 2019, Boston Scientific, a leading medtech company, received FDA approval for their Lotus Edge for the treatment of severe aortic stenosis. In the same year, Edward’s Lifesciences and Medtronic expanded their market coverage by gaining FDA approval for low-risk population for aortic stenosis. Boston Scientific then discontinued their device, resulting in the duopoly that the TAVR market is today.

Carlos continues: “Expanding to low-risk patients was the right move for Edward’s Lifesciences and Medtronic because it ultimately led to Boston Scientific’s exit from the market. Breaking into the market is certainly an uphill battle, especially with Edward’s Lifesciences possessing over 50% market share. Yet, companies are still eager to make their mark in the TAVR market.”

Abbott’s Navitor system already has CE approval in Europe; therefore, it is not completely new to the global TAVR market. Unique features of Navitor include a fabric cuff (i.e., NaviSeal) to prevent paravalvular leak and its self-expanding leaflet system.

Carlos concludes: “Navitor’s one-of-a-kind design does give it a competitive advantage over its two competitors in the TAVR market. However, its system is only indicated for severe aortic stenosis, similar to Boston Scientific’s Lotus Edge. Navitor may have a unique design, but only time will tell if that is enough for Abbott to become a third major player in the market.”