ATLANTA – The Emory Heart & Vascular Center is one of five centers in the U.S. conducting a study to evaluate a novel device to help lower high blood pressure without the use of medication. Emory was the first site in the world to implant the device on August 21.

The FDA-sanctioned, first-in-man clinical trial known as the CALM-FIM_US study is evaluating the MobiusHD^™ device, a catheter-delivered implant permanently placed in the carotid artery of the neck.

It is designed for patients with treatment-resistant high blood pressure, also known as drug resistant hypertension, which occurs when a person’s blood pressure remains high despite taking at least three different medications to lower it.

“Hypertension continues to grow as a global epidemic,” says Emory Healthcare cardiologist Chandan Devireddy, MD, associate professor of medicine, Emory University School of Medicine and principal investigator of the trial at Emory.

“Despite advances in medical therapy, a growing number of patients suffer from drug resistance and this population has very few options available to modulate blood pressure once they have failed multi-drug therapy. The MobiusHD^™ device might offer a life-changing treatment option for patients with resistant hypertension.”

According to Devireddy, the minimally invasive procedure uses a catheter the size of one typically used in a cardiovascular procedure. It is advanced through a small puncture in the groin and threaded into the carotid artery.

Once there, the catheter delivers a metal implant to the carotid sinus designed to increase the signals generated by the surrounding arterial baroreceptors.  Baroreceptor nerve signals detect the pressure of blood flowing through them and send messages to the central nervous system to increase or decrease blood flow.  

 “Heart doctors have used catheters to perform carotid angioplasty and stent procedures in the arteries of the neck for years,” says Devireddy.  

“Drops in blood pressure are seen commonly during these procedures but last a short time. This new technology uses similar technology but solely for the purpose of stimulating the receptors in the artery to lower blood pressure.”

The CALM-FIM_US study is sponsored by Vascular Dynamics, Inc. and is a prospective, open-label, controlled, feasibility trial. For more information about the trial at Emory, please call 404-686-7478.