CDU Associate

CVRx (Minneapolis) received FDA approval for conditional investigational device exemption (IDE) for its Rheos baroreflex hypertension therapy system, an implantable device to treat high blood pressure.

The blinded study, sponsored by the company, is a prospective, randomized, multi-center trial that will be conducted at up to 40 sites in the U.S. The study seeks to determine the safety and effectiveness of the Rheos System when used in drug-resistant hypertension patients. To be enrolled in the trial, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic. Their systolic blood pressure must be greater than or equal to 160 mmHg.

CVRx's flagship product, the Rheos system, is intended for use in patients who cannot control their blood pressure with medications, or medication combined with lifestyle modifications. The device provides what physicians might describe as a "physiologically rational" method to reduce blood pressure. It is designed to do this with the use of mild electrical signals to influence the body's blood pressure regulation system, called the baroreflex.

According to Robert Kieval, founder, vice president and chief technology officer of CVRx, the Rheos is a pacemaker-like device designed to stimulate tissues within the body.

"We stimulate areas of the vascular system that have sensors in them that report blood pressure to the brain," Kieval told Cardiovascular Device Update. "The brain compares what it believes is the blood pressure to the needs of the body and then makes the appropriate adjustments."

He likened the mechanism of action to the ability to cool a room by holding a match under a thermostat: "The heat of a match fools the thermostat into thinking that the entire room has become too warm and causes the air conditioning system to be activated."

Early results for the first 12 patients were reported at the annual meeting of the European Society of Hypertension (Milan) in June. In this study, after three months of active Rheos therapy, systolic blood pressure was reduced by an average of 24 mmHg (189 mmHg vs. 165 mmHg).

There were no unanticipated serious adverse events related to the system or procedures.

The company said that initial U.S. results will be presented at the American Heart Association (AHA; Dallas) annual meeting being held in Chicago in November.