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December 3, 2019updated 19 Jan 2022 5:44am

LivaNova abandons transcatheter mitral valve replacement device market

By GlobalData Healthcare

LivaNova recently announced its decision to discontinue investments into its Caisson Interventional transcatheter mitral valve replacement (TMVR) programme. The decision to end the programme enables the company to focus on restructuring its biological and mechanical valve business, which experienced a decline over the last five years.

Mitral valve regurgitation is one of the most prevalent heart valve diseases. It affects almost 10% of the US population over the age of 75 alone. Interventional treatment of valvular diseases has been moving toward a minimally invasive, transcatheter approach. This is particularly true for the older population as they are at higher risk for developing post-surgical complications. Transcatheter aortic valve replacement (TAVR) devices are experiencing high growth, replacing the traditional surgical alternative. Currently, the only treatment method of mitral valve replacement for those with severe mitral valve regurgitation is through open surgery. Major manufacturers such as Abbott, Edwards, and Medtronic, in addition to other smaller companies, have several devices under clinical trials All are hoping to be the first to enter this market with the first TMVR device for this patient population.

Transcatheter treatment widens the patient pool

GlobalData estimates that severe mitral valve regurgitation is growing at a compound annual growth rate (CAGR) of approximately 5–7%. However, less than 10% of those patients undergo a mitral valve replacement. By introducing a transcatheter treatment option, this creates an opportunity to treat a much larger patient pool. This is by expanding to those who are not able to undergo traditional surgery. It also significantly improving outcomes through the overall benefits of minimally invasive interventions compared to open surgery.

While LivaNova’s decision to end its TMVR programme was to redirect the company’s focus on restructuring its current heart valve business, GlobalData expects the future opportunity to lie in transcatheter heart valves. As the adoption of transcatheter devices grows, the surgical valve market will inevitably experience a plateau or decline in the future.

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