CVRx's Barostim Neo System Lands CE Mark for Heart Failure Treatment
Minneapolis, Minn.-based devicemaker CVRx has received a CE mark for the Barostim neo system to treat heart failure patients, the company said Monday.
The device triggers the body’s own natural blood flow regulation system to treat patients with chronic heart failure and hypertension, according to CVRx.
The approval is based on results from a randomized clinical trial of 140 patients with advanced hypertension, conducted in the U.S., Europe and Canada. The trial demonstrated a reduction in sympathetic activity, correlating into a reduction of hospitalizations, CVRx CEO Nadim Yared said.
The long-term safety profile of the Barostim neo showed low rates of stroke, myocardial infarction and worsening of carotid stenosis in this population of patients, the devicemaker added.
The device will be available in all countries that observe the CE mark. In the U.S. it is still an investigational device, the company said. — Kellen Owings
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