Early Study Results with the Rheos® System Show Promise
The Rheos System has been studied in patients with uncontrolled high blood pressure. These patients were taking at least 3 blood pressure medicines. Even with medicine, they still had high blood pressure. Some of these patients also had early-stage heart failure.
Data on the impact of the Rheos Device on the heart was collected for 21 of these patients. Most of these 21 patients experienced positive results with the Rheos System such as2:
- Reduced size and thickness of the heart
- Improved heart function
- Reduced blood pressure
* Heart size and thickness are determined using a left ventricular mass index.
Bisognano JD. JACC 2009;53(10) Suppl A, A188.
Fifty seven percent of these patients had hearts of normal size and thickness after one year with the Rheos System.
Two of the 21 patients experienced events such as: device movement, high blood pressure episodes, and surgical complications. All events were resolved.
These results offer hope for people with heart failure. Now a larger study is needed to evaluate the safety and effectiveness of the Rheos System in these patients.
2. Bisognano JD, de Leeuw P, Bach DS, Kaufman CL, Eric G. Lovett, for the DEBuT-HT and Rheos Feasibility Investigators. Improved Cardiac Structure and Diastolic Flow Velocities in Early-Stage Heart Failure with Chronic Treatment Using an Implantable Device: Results from European and United States Trials of the Rheos® System. JACC 2009:53(10) Supp A, A188.
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.