FDA approves bioelectronic device for hypertension from Valencia Technologies

Valencia Technologies Corporation, developers of medical devices, has received approval of the U.S. Food and Drug Administration's Investigational Device Exemption to begin a study on a treatment of drug-resistant hypertension.

The eCoin System is a small neurostimulator implanted in the forearm that uses low-duty cycle current to automatically stimulate the median nerve for 30 minutes once a week. This automated technique can help reduce patient compliance issues because of the limited weekly time commitment.

"In my clinic, most patients understand the ill effects of hypertension. However, many of them find it difficult to take their prescribed anti-hypertensive medications either due to financial restraints or intolerable side effects," said Atul Chugh, MD, attending cardiologist at St. Francis Hospital in Indianapolis. "The 'holy grail' of hypertension management therefore lies in a therapy that is both cost-effective and easily tolerated. Preliminary data from the first in-human studies suggest eCoin may be efficacious and easily tolerated—and hopefully cost-effective."

"The implant procedure is easily performed under local anesthesia and takes 10 minutes to do per arm," said Subhro K. Sen, MD, assistant professor at Stanford Medical School and developer of the eCoin Implant Procedure. "The procedure is minimally invasive and has a low risk profile."

The study will include 300 participants, who are on at least three three antihypertensive drugs, and be split into a treatment group and control group. All participants will receive the eCoin therapy but the control group will have theirs activated at the six-month mark.

"The results of the first-in-human study of the Valencia eCoin System were compelling and helped us to determine which patients could most likely benefit from median nerve stimulation," said William B. White, MD, professor at the University of Connecticut School of Medicine and a former president of the American Society of Hypertension. "The new pivotal study in the U.S. is important for device research in the field and if results show a positive benefit on ambulatory and clinic blood pressure, it will have an important impact on the future management of drug-treatment resistant hypertension."