FDA approves clinical trial for eCoin hypertension treatment

A new study to examine the efficacy of an implantable hypertension treatment has been approved by the U.S. Food and Drug Administration.

The treatment, which has been branded eCoin System, is made by Valencia Technologies, a medical technology company in Valencia, California. eCoin is a fully implantable, leadless, coin-sized neurostimulator that is placed in each forearm during the 20-minute procedure. Through neuromodulation, it helps the nervous system and brain work together to release natural chemicals that treat various chronic conditions.

In addition to hypertension, eCoin can also treat heart failure, depression, obesity and erectile dysfunction.

"The implant procedure is easily performed under local anesthesia and takes 10 minutes to do per arm,” said Subhro K. Sen, MD, one of the developers of eCoin and a clinical assistant professor in the division of plastic and reconstructive surgery at Stanford Medical School, in a statement. "The procedure is minimally invasive and has a low risk profile."

The study is set to enroll 300 patients who are on at least three antihypertensive drugs and examine how eCoin affects them after six months. The tested population will be compared to a control group. Valencia already has 30 centers recruited and is ready to begin as soon as all conditions are approved.

"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, a cardiologist at St. Francis Hospital in Indianapolis, in a statement. "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."