Abbott Laboratories’ Trifecta GT aortic valve has been in use to treat damaged native or prosthetic aortic heart valves since its FDA approval in 2016. However, the company recently announced that they will be withdrawing the product line from the US tissue sutured aortic valve replacement (sAVR) market. The withdrawal is expected to benefit Edwards Lifesciences, the dominant player in the US sAVR market, which is currently valued at $166 million,  according to GlobalData, a leading data and analytics company.

Joselia Carlos, Medical Devices Analyst at GlobalData, comments: “Abbott decided to remove its Trifecta GT aortic valve from the US market due to the increasing incidence of structural valve deterioration. Market dynamics will likely shift following this product’s removal from the market.”

Edwards Lifesciences is the leading player in the US tissue sAVR market with a share of 57%, while Abbott only has less than a 5% share as of 2022. Given that Abbott now only has one product in the US tissue sAVR market, the Biocor Stent Tissue valve, some of its original share will go to Edwards Lifesciences.

Carlos continues: “We are left guessing Abbott’s next steps following the Trifecta valves’ withdrawal, as the company simply stated they will focus on future tissue heart valve solutions that will manage and treat valvular heart disease. With only one product in this market now, it may be worth assessing on Abbott’s end if it is worthwhile to remain in the market with such a competitive player like Edwards Lifesciences.”

Another route where Abbott may focus on generating heart valve solutions is diverting their efforts to the transcatheter aortic valve replacement (TAVR) market, which in the last decade has become an alternative to tissue aortic valves. Currently, the TAVR market is valued at approximately $7 million and is expected to grow to almost $19 million in 2033 with a compound annual growth rate (CAGR) of 9%.

Carlos concludes: “Lack of expertise required to perform TAVR procedures, the invasiveness of the procedure, and the high cost of TAVR devices are potential reasons for the conservative 9% CAGR for the forecast period 2023-33. TAVR cannot completely replace prosthetic heart valves. Interestingly, Edwards Lifesciences also dominates the TAVR market, in addition to the prosthetic heart valve market. Abbott definitely has a tough competitor in the heart valves market.”