Featured Research

from universities, journals, and other organizations

Significant Reduction In Blood Pressure With Implantable Device System

Date:
November 20, 2006
Source:
University of Rochester Medical Center
Summary:
A device first implanted in the United States at the University of Rochester Medical Center as part of a clinical trial is showing a significant reduction in blood pressure in patients who suffer from severe hypertension and cannot control their condition with medications or lifestyle changes.

A device first implanted in the United States at the University of Rochester Medical Center as part of a clinical trial is showing a significant reduction in blood pressure in patients who suffer from severe hypertension and cannot control their condition with medications or lifestyle changes.

Early findings were shared recently by University of Rochester Medical Center cardiologist John Bisognano, M.D., Ph.D., and Minneapolis-based device-maker CVRx at the American Heart Association 2006 Scientific Sessions in Chicago.

The ongoing study is assessing the safety and clinical efficacy of the RheosTM Baroreflex Hypertension TherapyTM System, an implantable device for the treatment of hypertension in patients with drug-resistant hypertension, who have a systolic blood pressure of 160 mmHg or greater. The University of Rochester implanted the first device in the U.S. in March 2005, and performed a total of three of the initial 10 implantations.

Hypertension affects about 65 million people in the U.S. It is estimated to cause one in every eight deaths worldwide. Each increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal level is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.

"The Rheos System is a novel device that activates the carotid baroreflex, the body's own system for regulating blood pressure," Bisognano said. "We are pleased with the clinical results to date and look forward to expanding the clinical evaluation of the Rheos System. New approaches to the widespread, chronic and costly problem of hypertension are needed. The Rheos System has the potential to prevent the progression to more serious illnesses, including heart and kidney disease, stroke and death."

The system works by electrically activating the baroreflex system based in the carotid arteries in the neck. Low-level electrical stimulation to this area sends signals to the brain, "telling" it to take action to lower blood pressure through a variety of mechanisms, including blood vessel dilatation, heart rate reduction and promotion of fluid excretion by the kidneys. In this way, the system provides a physiologic approach to reducing high blood pressure by allowing the brain to direct the body's own control mechanisms. It consists of a battery-powered implantable generator, which is inserted under the skin near the collarbone, and two carotid sinus leads, which run from the generator to the left and right carotid sinus in the neck. While implantation is slightly more involved, the general principle is similar to the implantation of cardiac pacemakers.

The trial is designed to assess device safety and efficacy in patients with systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including one diuretic. The presentation reported on the first 10 U.S. patients enrolled in the trial. After one month of surgical recovery, baseline blood pressure was assessed and the device was activated. Three months of active Rheos therapy reduced systolic blood pressure by an average of 22 mmHg (180 mmHg vs. 158 mmHg) and diastolic blood pressure by an average of 18 mmHg (105 mmHg vs. 87 mmHg), using office cuff measurements. The implants were well tolerated and there were no unanticipated serious adverse events related to the system or procedure.

In October, CVRx received a conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration to begin a pivotal clinical trial that will evaluate the safety and effectiveness of the RheosTM Baroreflex Hypertension TherapyTM System in a much larger number of patients. The University of Rochester team recently implanted a fourth device as part of the study.

"These interim clinical results are favorable and promising for the many people with drug-resistant hypertension," said Nadim Yared, president and CEO of CVRx. "We are excited about launching our pivotal trial and look forward to working with our investigators."


Story Source:

The above story is based on materials provided by University of Rochester Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

University of Rochester Medical Center. "Significant Reduction In Blood Pressure With Implantable Device System." ScienceDaily. ScienceDaily, 20 November 2006. <www.sciencedaily.com/releases/2006/11/061116083255.htm>.
University of Rochester Medical Center. (2006, November 20). Significant Reduction In Blood Pressure With Implantable Device System. ScienceDaily. Retrieved October 20, 2014 from www.sciencedaily.com/releases/2006/11/061116083255.htm
University of Rochester Medical Center. "Significant Reduction In Blood Pressure With Implantable Device System." ScienceDaily. www.sciencedaily.com/releases/2006/11/061116083255.htm (accessed October 20, 2014).

Share This



More Health & Medicine News

Monday, October 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

How Nigeria Beat Its Ebola Outbreak

How Nigeria Beat Its Ebola Outbreak

Newsy (Oct. 20, 2014) The World Health Organization has declared Nigeria free of Ebola. Health experts credit a bit of luck and the government's initial response. Video provided by Newsy
Powered by NewsLook.com
Another Study Suggests Viagra Is Good For The Heart

Another Study Suggests Viagra Is Good For The Heart

Newsy (Oct. 20, 2014) An ingredient in erectile-dysfunction medications such as Viagra could improve heart function. Perhaps not surprising, given Viagra's history. Video provided by Newsy
Powered by NewsLook.com
Ebola Worries End for Dozens on U.S. Watch Lists

Ebola Worries End for Dozens on U.S. Watch Lists

Reuters - US Online Video (Oct. 20, 2014) Forty-three people who had contact with Thomas Eric Duncan, the first person diagnosed with Ebola in the U.S., were cleared overnight of twice-daily monitoring after 21 days of showing no symptoms. Rough Cut (no reporter narration). Video provided by Reuters
Powered by NewsLook.com
Fauci: Ebola Protocols to Focus on Training

Fauci: Ebola Protocols to Focus on Training

AP (Oct. 20, 2014) Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, says he expects revised CDC protocols on Ebola to focus on training, observation and ensuring health care workers are more protected. (Oct. 20) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins