Hypertension affects 73 million Americans and is the leading cause of stroke, heart attack, heart failure and kidney disease according to the American Heart Association. About 25 percent of people with hypertension are unable to control their high blood pressure despite medication, adoption of a healthier lifestyle and other therapies.
To treat this condition, CVRx Inc., a private company, developed a device that stimulates the body’s natural system of lowering blood pressure currently being implanted in select patients across the United States.
Only a limited number of U.S. facilities can perform the surgical procedure involving the device that is currently being studied in an FDA-approved clinical trial.
“We’re very excited that we have the opportunity to offer the advanced technology to people at the end of the road whose doctors have exhausted every option to treat them” said Dr. Robert Feldtman, a cardiovascular surgeon responsible for implanting the device in qualifying Central Texas patients at Scott & White Hospital in Temple.
The device is designed to electrically activate the baroflex, the body’s natural blood pressure regulation system, to watch and control blood pressure. The procedure requires implanting a pulse generator, or battery, and wires under the collarbone, which send signals to the brain suggesting a blood pressure increase. The procedure is similar to a cardiac pacemaker implantation, Dr. Feldtman said.
Investigators at Scott & White Hospital are currently screening patients for participation in the Rheos Pivotal Trial. To qualify, patients must have persistent high blood pressure despite regular treatment with medications.
“Before the implant I took 17 pills a day and since I’ve had the device, I only need one,” said David K., one of 50 patients in the U.S. enrolled in the study. “I’m living proof that it doesn’t have to be that way.”
Sponsored by CVRx Inc., the trial aims to demonstrate that the product, the CVRx Rheos Baroflex Hypertension Therapy System, is a safe and effective treatment for patients to lower uncontrolled high blood pressure.
Clinical studies in Europe have been ongoing for the past four years and results show a significant reduction in implanted patients’ blood pressure according to reports from the European Society of Hypertension in 2007.