Neovasc jumps despite slow movement towards the US

Two-year data from a European trial of Neovasc’s Reducer cardiac implant drove the group’s stock up 12% yesterday – remarkable considering that the product has been on sale in Europe for the past eight years. It is doubly surprising given that Reducer, intended for the percutaneous treatment of refractory angina, appears to have no path towards US approval set out. The results, published in the International Journal of Cardiology, bear out the device’s safety and efficacy at two years and showed no device-related adverse events among the 50-patient cohort. 34 patients (76%) had improvements on the Canadian Cardiovascular Society of at least one class and 16 (36%) improved by at least two classes. Five patients died, two of cardiovascular events. In the US, however, no clinical trials appear to be under way, despite Reducer having recently gained breakthrough device designation. The product is therefore several years away from this crucial market, even in the best-case scenario. Neovasc’s other device, the Tiara transcatheter mitral valve, is even further behind. In its European pivotal trial, Tiara-II, 25 of a planned 115 patients had been treated as of March; results will not appear until early next year.

The Reducer implantation procedure

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