CVRx® Granted Humanitarian Device Exemption Approval from FDA for Barostim neo legacy™ Hypertension Therapy Device

MINNEAPOLIS, Dec. 16, 2014 /PRNewswire/ -- CVRx, Inc., a privately held medical device company, announced today that it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its Barostim neo legacy device. This milestone represents CVRx's first commercial approval in the United States and is based on a determination by the FDA that neo legacy is safe and can be used in U.S. patients who were defined as responders to the Rheos Carotid Sinus Lead System.

"We are excited that our early clinical subjects who are actively being treated in our hypertension feasibility and pivotal studies will be able to maintain access to continued therapy through the HDE approval. All of these patients have been treated for over five years with Barostim Therapy, said Nadim Yared, CEO of CVRx. "During that time, CVRx has remained committed to providing access to Barostim Therapy for patients. My team and I want to thank our investigators, clinical research coordinators, investors, and especially our pioneering patients for their commitment to the therapy. We also want to thank FDA for interactively working with us on this unique approval."

About Barostim Therapy™ 
Five-year results of the 322-patient sham-controlled Rheos Hypertension Trial were presented at the American Society of Hypertension and the joint European and International Societies of Hypertension annual scientific conferences in May and June of 2014. The results showed a persistent and statistically significant reduction of systolic and diastolic blood pressure in excess of 32mmHg and 17mmHg, respectively, over the course of 5 years. In addition, the long term safety profile of the therapy proved to be excellent with very low rates of stroke, myocardial infarction and worsening of carotid stenosis in this population of patients with advanced hypertension.^[1],[2] 

Barostim Therapy is included in the joint European Society of Hypertension and European Society of Cardiology guidelines for the treatment of resistant hypertension that were published in June, 2013.^[3]

CVRx has completed 6 month follow-up in a 146 patient randomized, controlled clinical trial to demonstrate the performance of Barostim Therapy in 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.^[4] The six month results from the randomized, controlled trial are being prepared for publication.

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 and 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 provides 100 percent compliance to treatment by continuously activating the baroreflex;
• It is compatible with and complementary to implantable cardio-defibrillators and cardiac resynchronization therapy^[5]; and
• It is now MR Conditional, or safe for use under specified conditions in Europe

About Hypertension
In Europe, the prevalence of hypertension is estimated to be between 30-45% of the general population.^[3]  In the United States, hypertension affects 77.9 million people.^[6] Worldwide, hypertension is estimated to cause one in every eight deaths.^[7]  It is a major risk factor for cardiovascular disease, morbidity and mortality. Twenty-five percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications.^[6],[7]  It is a disease that needs new treatment solutions.

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.^[8]  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.^[8]

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 in addition to CE Marking for hypertension in Europe. Barostim neo legacy has received CE Marking for hypertension in Europe and HDE in the United States. It is under clinical evaluation for the treatment of heart failure and hypertension in the United States.  

Footnotes:

1. Bakris G, et al.  Baroreflex activation therapy reduces blood pressure for at least five years in a large resistant hypertension cohort. J Am Soc Hypertens. 2014; 8(4S) e9-e10
2. de Leeuw P, et al. Validation of long-term blood pressure control with baroreflex activation therapy in a large cohort of resistant hypertension patients. Journal of Hypertension. 2014;  Vol 32, Suppl. 1; 27 
3. Mancia G, et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension.  European Heart Journal 2013 34 (28): 2159-2219
4. 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
5. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrilator: Compatible, complementary therapies. Europace Feb, 2014
6. Chobanian AV. JNC 7: Complete Report. JAMA 2003;289:2560-2572
7. Prospective Studies Collaboration. Lancet 2002;360:1903-1913
8. 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.

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SOURCE CVRx, Inc.

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