Valencia Technologies said today it won investigational device exemption approval from the FDA to begin a trial of its eCoin neurostimulator for treating drug-resistant hypertension.
The company is slated to pick up 300 patients on at least 3 antihypertensive drugs for a trial of the coin-sized device, which is designed to be placed in the forearm during a short in-office procedure under local anesthesia.
“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. 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,” Dr. Atul Chugh of Indianapolis’ St. Francis Hospital said in a press release.
The study aims to explore treatment effect after 6 months compared to a sham-control group. Patients in the sham-control group will have their devices activated at the 6-month point, the company 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. 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,” Dr. William White of the University of Connecticut School of Medicine said in a prepared statement.
Valencia said it has recruited more than 30 centers for the study so far, and will initiate the trial “as soon as the conditions of the approval are satisfied.”
Last December, Valencia Technologies CEO Jeff Greiner spoke to MassDevice.com about how he and Valencia spent less than $10.5 million designing the device and getting it through a double-blind clinical trial.
Greiner had quite a history before joining Valencia, having led Advanced Bionics from its start as a team of 7 engineers into a 3,000-employee juggernaut with $300 million in annual sales.
The early, 48-patient double-blinded trial compared subjects treated with the Valencia device with patients treated with a placebo (all patients were implanted with the device, but it was not activated for subjects in the sham arm). The study tracked blood pressure via 24-hour ambulatory measurement, showing a reduction in systolic blood pressure of 7.3mm Hg at 3 months.
That number grew to 7.8mm Hg at 6 months and 9.8mm Hg at 9 months, according to Valencia’ s website. The difference between the treatment and sham groups was 5.7mm Hg at 3 months and 11mm Hg after 6 months, according to the company.
As evidence that Valencia’s approach could address a significant unmet need, Greiner cited results from a National Institutes of Health study showing that aggressive blood pressure management reduces the risk of death and cardiovascular events when compared to a strategy that only lowers systolic blood pressure to standard targets.