CVRx® Barostim Therapy™ for Heart Failure Clinical Trial Results Presented in a Featured Clinical Research Session of the American College of Cardiology Annual Conference
Minneapolis – March 17, 2015 – CVRx, Inc., a private medical device company, announced that positive results from the Barostim Therapy for Heartn Failure randomized, controlled clinical trial were presented at American College of Cardiology (ACC) in a Featured Clinical Research Session. Results were presented by Dr. William Abraham from The Ohio State University, who served on the trial’s Steering Committee.
“We are very encouraged by the results from the Barostim neo™ – Baroreflex Activation Therapy for Heart Failure Study”, said Dr. Abraham. “Barostim proved to be safe and significantly improved patient functional status, quality of life score, exercise capacity, serum biomarkers of heart failure severity (NT-proBNP), and suggested that the burden of heart failure hospitalizations may also be reduced with Barostim Therapy.”
“The positive results from our randomized, controlled clinical trial were well received at ACC”, said Nadim Yared, CEO and President of CVRx. “The safety and effectiveness data presented simultaneously with the online publication of the manuscript in JACC-HF, will further support our commercial success in Europe.”
About Barostim Therapy™
CVRx completed a 146 patient randomized, controlled clinical trial to determine the performance of Barostim Therapy for patients suffering from chronic heart failure with advanced symptoms. Promising results from an earlier study demonstrating clinical improvement and reduced hospitalizations have been presented and published.1
About Barostim neo™
Barostim neo is a second generation device that uses CVRx-patented technology that is designed to trigger the body’s own natural blood flow regulation system to treat patients suffering from chronic heart failure. The therapy is also a treatment option for patients with resistant hypertension. The system works by electrically activating the baroreceptors, the body’s natural sensors that regulate cardiovascular function. By activating this afferent pathway, Barostim restores sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.
Key unique benefits:
The Barostim neo can be turned on and off to demonstrate acute results;
It can be adjusted to meet each patient’s individual therapy needs;
It is a reversible treatment;
It provides 100 percent adherence to treatment by continuously activating the baroreflex;
It is compatible with and complementary to implantable cardiac rhythm management devices2 ; and
It is now MR Conditional, or safe for use under specified conditions in Europe
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 5.1 million adults.3 Overall, heart failure is associated with a four-fold increased risk of death and a six to nine times increased risk of sudden cardiac death. The direct and indirect costs of heart failure are estimated to be $32 billion in the United States in 2013.3
About CVRx, Inc.
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis. The company has developed the second generation Barostim neo, an implantable system designed to treat heart failure and hypertension (high blood pressure). Barostim neo has received CE marking for the treatment of heart failure. Barostim neo has also received CE marking for the treatment of hypertension. It is under clinical evaluation for the treatment of heart failure and hypertension in the United States.
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1. Gronda E, et al. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function and cardiac haemodynamics in heart failure: a proof of concept study. European Journal of Heart Failure 2014; 16(9):977-983
2. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrillator: Compatible, complementary therapies. Europace Feb, 2014
3. Go A, Heart Disease and Stroke Statistics. American Heart Association – 2013 Update. Circulation 2013;127:e6-e245
CAUTION: Barostim neo™ is an investigational device and is limited by United States law to investigational use. Exclusively for Clinical Investigations for the treatment of heart failure and resistant hypertension in Canada.
CVRx, HOPE4HF, Barostim neo and Barostim Therapy are trademarks of CVRx, Inc. registered in the United States Trademark Office.
© CVRx, Inc. 2014. All rights reserved.