Over the last few years, we’ve been covering the ongoing testing of a blood pressure management system from CVRx out of Minneapolis, MN. The Rheos™ Baroreflex Hypertension Therapy™ System is an implantable device that monitors the patient’s blood pressure and, based on the readings, electrically stimulates the carotid baroreceptors. Located inside carotid sinuses, these baroreceptors are partially responsible for blood pressure regulation. Now a new clinical trial has been initiated to test the system’s effectiveness for management of diastolic hypertension, and a Florida man is now the first person to be implanted with the Rheos to deal with this condition. The device has already received European approval, and this latest trial may earn it FDA clearance in the US.
From St. Petersburg Times:
In the future, as many as 1.5 million heart failure patients could become the target market for the new device, called the Rheos System, according to CVRx, the Minneapolis company that developed it. It is being assessed in clinical trials that will involve more than 500 patients.
Physicians at TGH are familiar with implanting the Rheos System, which they used in another clinical trial for high blood pressure. That trial is further along, yielding results that researchers thought showed promise for heart failure patients.
CVRx expects to spend tens of millions of dollars on the heart failure trial, including the cost of surgery and medical followup for patients like Cummings [Charles Cummings, first patient in the study]. Kieval [Robert Kieval, founder of CVRx] estimated the device could cost in the “tens of thousands” per patient.
Product page: Rheos System…
More from St. Petersburg Times: Rheos System adds heart failure trial to study of its effects on high blood pressure…
Flashbacks: RHEOS Device for Blood Pressure Control Undergoing New Trial; Positive Results from Trial of Rheos Baroreflex Hypertension Therapy; Novel Device for High Blood Pressure Implanted