CVRx, Inc., a private medical device company, introduced today its new second-generation implantable device, the Barostim neo TM and announced the launch of a clinical trial to evaluate Barostim therapy for the treatment of heart failure. The Barostim neo features a unilateral, 1mm electrode and a new smaller, more advanced generator to allow for more focused and efficient delivery of therapy, leading to shorter procedure times and extended longevity.
"By restoring sympatho-vagal balance, the Barostim neo has the potential to correct the major underlying pathophysiologies of patients with heart failure," said Professor Dr. Gerd Hasenfuss, Chair of the Heart Center and Heart Research Center, Göttingen, Germany.
ESC Symposium on Tuesday, August 30
Dr. Eugene Braunwald, the Distinguished Hersey Professor of Medicine at Harvard Medical School, and Chairman of the TIMI Study Group at the Brigham and Women´s Hospital; and Dr. Alberto Zanchetti, Professor Emeritus of Internal Medicine at the University of Milan and Scientific Director of the Istituto Auxologico Italiano, will co-chair a symposium titled Baroreflex Activation Therapy for Resistant Hypertension and Heart Failure at the European Society of Cardiology (ESC) Congress 2011 in Paris. The event will take place Tuesday, August 30 from 14:00 to 15:30 in the Sofia Lecture Room. The latest clinical trial results for the Barostim neo will be shared at this symposium.
Presenters include Professor Dr. Peter de Leeuw, University Hospital, Maastricht, Netherlands, Dr. Hani N. Sabbah, Wayne State University, Detroit, Michigan; and Professor Dr. Gerd Hasenfuss, Chair of the Heart Center and Heart Research Center, Göttingen, Germany.
For more information on the symposium please visit www.BATSatelliteSymposium.com.
First Patient Enrolled in Heart Failure Trial
CVRx received approval from authorities in major European countries and in Canada to begin the Barostim neo Trial for heart failure, and reported the first patient enrollment.
"We are pleased to report that the University of Cologne enrolled the first patient in the Barostim neo Trial for Heart Failure," said Professor Dr. Uta Hoppe, Principal Investigator of the trial. "Our previous experience with the first-generation Barostim Therapy in heart failure was very positive, as we saw significant improvements in both cardiac structure and function. We are excited about the potential for the Barostim neo and participation in this clinical trial, which will help us better understand the impact of this novel therapy on an expanded cohort of patients with heart failure."
How it Works
The Barostim neo uses CVRx-patented technology that is designed to trigger the body´s own natural blood flow regulation system to treat heart failure. The system works by electrically activating the baroreceptors, the body´s natural blood pressure sensors that regulate cardiovascular function. These baroreceptors are located on the carotid artery. When activated by the Barostim neo, signals are sent through neural pathways to the brain, which responds by telling the:
- Arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion;
- Heart to slow down, allowing more time for the organ to fill with blood; and
- Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart.
About Heart Failure
In heart failure, heart function is impaired, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.7 million adults. Overall, heart failure is associated with a four-fold increased risk in death and a six to nine times increased risk of sudden cardiac death. The estimated direct and indirect costs of heart failure total $37.2 billion annually in the United States.1
About CVRx, Inc.
CVRx, Inc. is a private company and is headquartered in Minneapolis. The company has developed the Barostim neo for the treatment of high blood pressure and heart failure. For more information, visit www.cvrx.com.
Footnotes:
1. Heart Disease and Stroke Statistics. American Heart Association 2010 Update.
Editor´s note: Link to media kit and images on CVRx´s website, www.cvrx.com.
