Keystone Heart may experience rocky start despite receiving CE mark amid COVID-19 pandemic, says GlobalData

Amid the ongoing COVID-19 pandemic, Keystone Heart secured CE approval for its cerebral embolic protection device, the TriGUARD3. However, GlobalData expects that the company will experience a rocky start as a result of the pandemic.

In March 2020, Keystone Heart announced that its TriGUARD3 device received CE approval. The cerebral embolic protection device is designed to deflect emboli from the cerebral vasculature during transcatheter aortic valve replacement (TAVR) procedures, reducing the risk of stroke. The TriGUARD3 is also the only commercially available device designed to protect all three cerebral vessels.

Sheryl Tang, Senior Medical Devices Analyst at GlobalData, comments: “GlobalData expects the global TAVR market to grow at a compound annual growth rate (CAGR) of approximately 20% over the next ten years. The increase in procedures will likely result in an increased need for cerebral embolic protection devices to minimize the risk of stroke during the procedure.

“As a result of the ongoing pandemic, major organizations such as the American College of Surgeons have recommended the indefinite suspension of elective and non-essential surgical procedures, including TAVR. The indefinite suspension will severely impact the growth of TAVR procedures over the next year, which will likely cascade to related device markets as well.

“While Keystone Heart was able to secure CE approval for its device, the company may experience an extremely rocky start and delay to the commercial launch of their product in Europe.”

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