Hypertension

Blood pressure is the amount of force exerted on the artery walls as blood flows through them. High blood pressure (hypertension) means that the force is too strong increasing a patient’s risk for stroke, heart attack, heart failure, peripheral artery disease, kidney disease, and eye damage.

Hypertension is highly prevalent, with 30% of American adults having hypertension. About half of hypertensive adults in the US have their blood pressure under control while the other half remain at an unhealthy level.

While antihypertensive drugs have been the primary available treatment option, the high rate of uncontrolled blood pressure suggests alternative therapies are needed. In fact, a recent NIH study called “SPRINT” reports that more intensive therapy aimed at lower blood pressure goals has significant health benefits in reducing cardiovascular disease and stroke. It seems clear that tighter blood pressure control will become the standard of care.

eCoin is a viable alternative therapy for the treatment of hypertension.  Tested in a rigorous OUS study involving a modest 48 patients, eCoin appears safe, effective, and well-liked by patients. However, a larger US study involving several hundred patients, whose purpose is to show both clinical and statistical significance, will be required for FDA approval of eCoin.

HOW eCoin FOR HYPERTENSION WORKS

eCoin for hypertension takes advantage of a highly innervated area of the forearm. Placed just under the skin to activate the median nerve, eCoin begins its work. eCoin puts out a relatively low-powered and well-tolerated electrical stimulus that communicates with the brain. The input goes to the hypothalamus, midbrain, and the medulla; the signal has multiple pathways to the brain’s blood pressure control center. The treatment is known to create a normalizing effect on blood pressure.

SIMPLE PROCEDURE

In a twenty minute office procedure, a two centimeter incision is made for the small pocket in each forearm. The coin-sized and shaped device (eCoin) is placed just under the skin above two tendons that easily map the target nerve. A variety of physicians can do the simple procedure.

PROBABILITY OF SUCCESS

The recently announced NIH-funded SPRINT study makes clear that intensive treatment of hypertension will become the standard of care and physicians now need additional and alternative therapies to help them achieve better control for their hypertensive patients. In this context, the interim OUS study results on eCoin in drug treatment resistant patients demonstrate a clinically meaningful reduction of high blood pressure in all patients and particularly in those who appear to be more receptive to neuromodulation—about 70% of the population. The eCoin achieves these reductions with a relatively benign safety profile and none of the side-effects of drugs. Both the patients who have experienced the therapy and the leaders of the clinical hypertension community in the US are enthusiastic about its potential—a potential expected to be realized in the IDE study.

PATIENT SATISFACTION

In a survey of all 48 patients participating in Valencia’s outside-US (OUS) study, patients reported their level of satisfaction with eCoin. Satisfaction data was collected on the case report form (CRF) at each follow-up visit (1-month, 3-month, 6-month, 9-month, 12-month, 18-month, & 24-month). The available options from which patients elected their level of satisfaction were: Not at all Satisfied, Slightly Satisfied, Somewhat Satisfied, Very Satisfied, and Completely Satisfied. Impressively, 42 out of 48 patients reported being very or completely satisfied with eCoin at their most recent follow-up visit (as of 12 Oct 16).

PATIENT PREFERENCE

In a survey of over 1,200 patients taking 3+ antihypertensives for hypertension, patients were asked about their attitude toward blood pressure control, drug-taking, and potential alternative therapies. The respondents were 55.5% female/44.5% male. Patients also self reported their stage of hypertension: Pre-hypertension (28%); Stage 1 (50%); Stage 2 (12%); and Unknown (10%). Renal denervation, the principle competitive technology which is in the testing phase, and Valencia’s coin were described using laymen’s terms and illustrations. When asked which therapy they prefer, 9 out of 10 patients preferred eCoin over renal denervation.