Amidst the ongoing Covid-19 pandemic, Keystone Heart Ltd 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, Keystone Heart Ltd 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.

Recent advancements to the TAVR market over the past year, such as expanded indications to low-risk patients, have resulted in a very optimistic outlook on the procedure over the next five to ten years as it becomes the intervention of choice over traditional valve surgery. GlobalData expected 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 minimise the risk of stroke during the procedure.

Prior to the outbreak of Covid-19, GlobalData expected an optimistic outlook on the TAVR market as well as any related device markets. However, as a result of the ongoing pandemic, major organisations such as the American College of Surgeons have recommended the indefinite suspension of elective and non-essential surgical procedures. TAVR is considered a non-urgent procedure and GlobalData expects that 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 Ltd was able to secure CE approval for its device and may prove to be a strong competitor with Boston Scientific’s Sentinel device, the company may experience an extremely rocky start and delay to the commercial launch of its product in Europe.