Valencia Technologies scored an FDA Investigational Device Exemption approval for its neurostimulator that treats drug-resistant hypertension. Under the approval, the company must launch a multicenter, pivotal study for the device.
The eCoin System is a fully implantable, leadless, coin-sized neurostimulator that is positioned in each forearm under local anesthesia, according to a statement. The automated therapy stimulates the median nerve for 30 minutes once a week, thereby “nearly” eliminating problems with patient compliance. Additionally, the treatment does not involve paresthesia, or a tingling sensation that often accompanies neurostimulation.
The pivotal study will enroll 300 patients who are taking at least three antihypertensive drugs, Valencia said in the statement. Its goal is to assess the therapeutic effect after receiving neurostimulation for 6 months. The treatment group will be compared to a sham-control group.
"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 Dr. William White, a professor in the Calhoun Cardiology Center at the University of Connecticut School of Medicine, in the statement. "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."
Drug-resistant hypertension, in which patients cannot control their blood pressure even with a diuretic and antihypertensive drugs, is just one of the conditions companies are targeting with bioelectronics. Also known as electroceuticals, bioelectronics, in theory, would control the body’s electrical impulses and induce it to heal itself from illness. They could be used in tandem with drugs or replace them entirely.
This summer, Israel’s BlueWind Medical and Irvine, CA-based Axonics both nabbed CE marks for their neurostimulators to treat overactive bladder, while Medtronic markets the InterStim SNM implant for the same indication in the U.S. Meanwhile, GlaxoSmithKline is betting on electroceuticals, having launched a $50 million venture fund in 2013 and planning to test third-party electroceutical devices next year. It hopes to debut its own device in 2019.