Medical technology firm Valencia Technologies has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the pivotal study of bioelectronic system for hypertension.
The approval enables the firm to commence a multi-center trail of the eCoin system for the treatment of drug-resistant hypertension.
In the trial, the company plans to recruit around 300 patients who are on at least three antihypertensive drugs. Valencia will carry out the trial in around 30 centers.
The eCoi system is a fully-implantable, leadless and coin-sized neurostimulator, which will be placed in each forearm during a 20-minute office procedure under local anesthesia.
It uses low-duty cycle current to automatically stimulate the median nerve once a week for 30 minutes.
According to the company, the goal of the pivotal study is to examine the treatment effect after six months of therapy.
Valencia said that its coin-sized and shaped bioelectronic device can be implanted near various target nerves for the treatment of a number of chronic conditions.
The company is also planning to start feasibility studies for the device in heart failure, overactive bladder, and osteoarthritis.
The eCoin implant procedure developer Dr Subhro Sen said: "The implant procedure is easily performed under local anesthesia and takes 10 minutes to do per arm.”
The US pivotal study national principal investigator Dr William White said: “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.”