May is Hypertension Awareness Month, and a new device in high blood pressure clinical trials is showing promise for treating U.S. hypertension (high blood pressure) patients whose condition is not controlled by drugs. Rheos® Hypertension (HT) Therapy is an implantable device designed to lower high blood pressure - the number one risk factor for stroke, heart and kidney disease.
"The Rheos Device is an innovative treatment approach for patients unable to control their high blood pressure with conventional medications," said Nadim Yared, CVRx president and CEO. "The Rheos system is designed to reduce patients' blood pressure by utilizing the body's own mechanisms."
The device may help patients who do not respond to drugs or are unable to maintain complex medication regimens. The Rheos System is currently in a pivotal clinical trial, and data will be used to support an application for marketing clearance to the Food and Drug Administration. The device has received CE Mark approval in Europe.
David Kessel, one of the first patients to receive a Rheos implant in a previous high blood pressure clinical trial, began experiencing hypertension when he was a teenager. "Before being outfitted with the Rheos device, I took 17 prescription pills a day and experienced few improvements," said Kessel. "My quality of life, and ability to be more active with my family, has improved dramatically since I received the Rheos device. I now take only one pill a day and have more energy to play with my kids and do the things that I wasn't able to before."
Recently published abstract results from an early Rheos high blood pressure clinical trial published in the Journal of Hypertension showed a significant decrease in blood pressure with the Rheos System at 12 months. One-year results from 13 patients showed a 39 mmHg average decrease in systolic blood pressure and a 26 mmHg average decrease in diastolic blood pressure.
About The Rheos Pivotal Trial and Rheos HT System
CVRx received investigational device exemption (IDE) approval from the FDA to begin the Rheos Pivotal Trial that is evaluating the safety and effectiveness of the Rheos HT System. The trial is enrolling 300 patients at multiple clinical sites in the United States and in Europe. Prospective patients can call (888) 8BP-RISK (827-7475) or visit bloodpressuretrial, to learn more about the clinical trial.
The Rheos HT System uses CVRx patented Baroreflex Activation Therapy™ (BAT™) technology that is designed to electrically activate the carotid baroceptors, the body's natural blood pressure sensors. When the baroreceptors are activated, signals are sent through neural pathways to the brain and interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by sending signals to other parts of the body (heart, blood vessels and kidneys) to lower high blood pressure.
The Rheos HT System includes the following components:
- A small pulse generator that is implanted under the collar bone;
- Two thin lead wires that are implanted at the left and right carotid arteries and connect to the pulse generator; and
- The Rheos Programmer System, an external device used by doctors to non-invasively regulate the activation energy from the generator to the lead wires.
About Hypertension
High blood pressure affects approximately 73 million people in the United States alone. It causes an estimated one in eight deaths worldwide. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications, according to the National Institutes of Health. Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes.
About CVRx, Inc.
CVRx, Inc., is a private company founded in 2001 and headquartered in Minneapolis. Its senior management and technical teams have many years of experience commercializing implantable medical devices.
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