Edwards Lifesciences, a medical technology company based in the US, has announced the complete acquisition of Innovalve Bio Medical, which specialises in transcatheter heart valve devices. The estimated $300m deal follows an initial investment by Edwards Lifesciences in Innovalve’s transcatheter mitral valve replacement (TMVR) research. Innovalve’s Innostay device recently received FDA approval to begin limited clinical trials in the US, with approval expected in 2026 or 2027. The acquisition will strengthen Edwards’s valve repair and valve replacement offerings as the market moves towards more minimally invasive devices.

TMVR is a procedure used to treat severe mitral valve regurgitation or mitral valve stenosis. The procedure is similar to transcatheter aortic valve replacement (TAVR); however, TAVR is only used to treat cases of aortic valve stenosis. These types of procedures are ideal for patients at high surgical risk or who are unable to undergo open-heart repair and replacement surgeries, such as those with existing conditions or the elderly. The acquisition by Edwards Lifesciences hopes to expand the treatable population for this kind of procedure, drawing on the company’s existing knowledge of heart valve devices and Innovalve’s product innovations.

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According to the GlobalData pipeline products database, there are currently 89 products in active development indicated for the treatment of mitral valve regurgitation. Of these devices, 60 are currently undergoing clinical trials to determine efficacy and safety for patients. In addition to Edwards Lifesciences and Innovalve, major medical device companies such as Medtronic plc and Abbott are also developing transcatheter-based mitral valve replacement devices, which Edwards may have to compete with in the future.

Edwards’s acquisition of Innovalve shows a need to continue to innovate within the transcatheter heart valve market. Innovation in this market hopes to increase the eligible population and reduce the reliance on risky open-heart surgeries. Other major manufacturers, such as Medtronic and Abbott, are also looking to develop new products within the market, which could indicate a high degree of growth in the next decade as more products can reach the market.

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