Subcutaneous Median Nerve Neuromodulation For Drug-Treatment Resistant Hypertension.

Hypertension is a serious public health issue, affecting approximately 30% of adults. Hypertension greatly contributes to the risk for heart disease and stroke, both among the top three leading causes of death in the Americas, Europe, and Asia. While most treated individuals with hypertension are controlled on medication, diet and exercise, an estimated 12% are resistant to conventional medical intervention. Alternative effective treatments are still needed for this hypertensive patient population to mitigate the risk and incidence of mortality and morbidity. This original Investigational Device Application is for a study intended to confirm the safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin system to treat resistant hypertension. The eCoin device delivers electrical stimulation pulses to the median nerve from a small coin sized device placed under the skin of the distal anterior forearm. The implant delivers a weekly 30 minute treatment based on previous studies showing a long lasting and cumulative effect. The safety and efficacy of eCoin therapy has previously been demonstrated in a multinational, randomized, double-blind, sham-controlled study in New Zealand, Taiwan and Canada. This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled study of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted subcutaneously in the right and left forearms of patients with uncontrolled hypertension despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing period, subjects will be 1:1 randomized into either a treatment or control group. One half of the subjects have their devices activated (treatment) and the other half undergo a sham activation (control) to maintain participant blinding to their treatment allocation. During the six months post-randomization, the eCoin is ON in the treatment group and OFF in the control group.