FDA Grants Approval to Valencia’s eCoin Neurostim Trial

Valencia has achieved an investigational device exemption approval from the FDA to begin a trial of its eCoin neurostimulator for treating drug-resistant hypertension.

In a pre-clinical trial, 48 patients were equipped with the device, and the study tracked blood pressure via 24-hour ambulatory measurement that revealed a reduction in systolic blood pressure of 7.3mm Hg at 3 months.

Valenica is scheduled to choose 300 patients on at least three antihypertensive drugs for a trial of the device, which is to be placed in the forearm during a short in-office procedure under local anesthesia. — Cynthia Jessup