CVRx® Receives CE Mark Approval and Introduces New Implantable Device for Hypertension, the Barostim neo™

Professor Eugene Braunwald and Professor Dr. Alberto Zanchetti to chair symposium at the European Society of Cardiology (ESC) Congress 2011 and to share latest clinical trial results

Minneapolis – August 25, 2011 – CVRx, Inc., a private medical device company, introduced today its second-generation implantable device, the Barostim neo™, for the treatment of uncontrolled hypertension. The Barostim neo features a new unilateral, 1mm electrode and a new smaller, more advanced stimulator to allow for more focused and efficient delivery of therapy. These improvements have led to shorter procedure times and extended longevity.
“A therapy that effectively activates the baroreflex is a much-needed weapon in our armamentarium against resistant hypertension,” said Professor Dr. Hermann Haller, Director of the Department of Nephrology at Hannover Medical School in Germany, and Principal Investigator for the Barostim neo hypertension trial. “We are very excited about the new Barostim neo system and look forward to be able to provide it to the many patients who need it.”

CE Mark
Nadim Yared, president and chief executive officer of CVRx added, “We are delighted to receive CE Mark approval for hypertension. The advanced personalization capabilities offered by the Barostim neo enhance long-term efficacy by allowing physicians to adapt therapy as their patient’s clinical condition warrants. The latest clinical evidence obtained with the new system is exciting.”

ESC Symposium on 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.

 

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 high blood pressure. 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 Hypertension
Hypertension causes an estimated one in eight deaths worldwide.1 In the United States alone,
States alone, high blood pressure affects approximately 76.4 million people.1 Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.2, 3 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 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.

CVRx, Inc.
9201 West Broadway Avenue, Suite 650
Minneapolis, MN 55445
www.cvrx.com
John Brintnall, Chief Financial Officer
jbrintnall@cvrx.com
Ph: 763.416.2853

Footnotes:
1. Heart Disease and Stroke Statistics. American Heart Association 2010 Update.
2. JAMA 2003; 289:2363-2369.
3. Lancet 2002;360:1903-1913.