Open surgery has been the primary treatment for severe tricuspid valve disease such as tricuspid regurgitation (TR).
Simultaneously, these patients are typically not good candidates for receiving surgical treatment – patients exhibiting severe TR are usually older and therefore are considered high-risk due to advanced age and comorbidities.
The release of the minimally invasive transcatheter tricuspid valve replacement (TTVR) system, EVOQUE, by Edwards Lifesciences, offers these individuals an alternative and much safer way of receiving TR treatment.
The EVOQUE TTVR system received CE approval in October 2023 and US Food and Drug Administration (FDA) approval earlier this month.
This device is currently the only transcatheter therapy that is available to treat severe TR.
According to GlobalData, a leading data and analytics company, the approval of the EVOQUE system will greatly contribute to the TTVR market’s expected aggressive growth to more than $2bn by 2033.
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By GlobalData
Edwards Lifesciences’ monopolisation of the TTVR market has not deterred other companies from trying to enter the market.
In particular, Medtronic is still conducting its early feasibility study on its Intrepid System in patients with severe TR since receiving FDA breakthrough designation in 2020.
Countries with responsive regulatory and reimbursement agencies such as Germany, Switzerland, France, the US, and Japan are expected to observe adoption rates of 15-25% while countries with a more measured approach such as the UK, Spain, and Italy will likely see a 3-8% growth rate.
However, countries with developing economies such as India will likely see growth rates of 1-3%.
Barriers to TTVR adoption include high device cost and lack of training available for surgeons for TTVR implantation procedures.
While transcatheter devices such as the EVOQUE system have provided a safer and less risky alternative for receiving TTVR treatment, there is still a large, unmet clinical need for treating patients with severe TR, especially in developing countries.