Valencia Technologies Corp., a privately held medical device company, announced that it has gained U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval with conditions to launch a multi-center, pivotal study of its eCoin system for the treatment of drug-resistant hypertension. The study will enroll 300 patients who are on at least three antihypertensive drugs.
“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 Dr. Atul Chugh, attending cardiologist at St. Francis Hospital, Indianapolis. “The ‘holy grail’ of hypertension management therefore lies in a therapy that is both cost-effective and easily tolerated.” Dr. Chugh added, “Preliminary data from the first-in-human studies suggest eCoin may be efficacious and easily tolerated—and hopefully cost-effective.”
Valencia’s eCoin system is a fully implantable, leadless, coin-sized neurostimulator that is placed in each forearm during a 20-minute office procedure under local anesthesia.
“The implant procedure is easily performed under local anesthesia and takes 10 minutes to do per arm,” said Dr. Subhro K. Sen, clinical assistant professor in the Division of Plastic and Reconstructive Surgery of Stanford Medical School and developer of the eCoin implant procedure. “The procedure is minimally invasive and has a low risk profile.”
The eCoin system uses low-duty cycle current to automatically stimulate the median nerve once a week for 30 minutes. Unlike therapies involving paresthesia, patients do not always feel the stimulation. Because the device is fully implantable and therapeutic sessions are automated, patient compliance issues are nearly eliminated.
The goal of the pivotal study is to examine the treatment effect after six months of therapy. The treatment group will be compared against a sham-control group. Uniquely, this study will allow all enrolled subjects to receive the potential benefits of the eCoin therapy, as the control group members will have their devices activated at the six-month point.
One of the national principal investigators of the U.S. pivotal study is renowned physician William B. White, M.D., professor in the Cardiology Center at the University of Connecticut School of Medicine and a former president of the American Society of Hypertension. Dr. White opined, “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.” Dr. White added, “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.”
With more than 30 centers recruited, Valencia is ready to begin the study as soon as the conditions of approval are satisfied.
Valencia’s eCoin system is not approved for sale or commercial distribution, and is limited to investigational use only. For more information about Valencia’s upcoming pivotal study for the treatment of resistant hypertension: www.clinicaltrials.gov.
Valencia Technologies Corp. is a medical technology company located in Valencia, CA. Valencia’s coin-sized and shaped bioelectronic device, eCoin, can be implanted near various target nerves for the treatment of a number of chronic conditions. Feasibility studies in heart failure, overactive bladder, and osteoarthritis of the knee are planned to begin next year.
For more information on Valencia: www.valenciatechnologies.com.
(Source: PR Newswire)