19 November 2015
CVRx® Announces Expedited Access Pathway Designation by FDA for Barostim Therapy® for the Treatment of Heart Failure in Order to Accelerate Access for US Patients
Minneapolis – November 19, 2015 – CVRx, Inc., a private medical device company, announced that it received Expedited Access Pathway (EAP) Designation by FDA for Barostim Therapy® for the treatment of heart failure. The EAP designation is based on Barostim Therapy being intended to treat a life-threatening or irreversibly debilitating disease where there is no available treatment alternative. This groundbreaking initiative, recently launched by FDA, is intended to significantly accelerate access for US patients and their physicians to innovative medical treatments.
The EAP Designation applies to CVRx’s Phase III randomized, controlled clinical trial, Baroreflex Activation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF). CVRx is currently completing the selection and training of clinical investigative centers to participate in the trial.
“We applaud FDA for creating the EAP Designation. This comes at a critical time for heart failure physicians, who are actively looking for treatment options for patients who are not adequately managed with current guideline-directed therapies”, said Dr. William Abraham, Director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center. “Barostim Therapy is designed to activate the Baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity. Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes. This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies.”
About Barostim Therapy for Heart Failure
Positive safety and efficacy results from a 146-patient randomized, controlled clinical trial were presented at the American College of Cardiology, Heart Rhythm Society, European Society of Cardiology Heart Failure, and Transcatheter Cardiovascular Therapeutics Annual Scientific Sessions in 2015. Results at six months showed that patient symptoms, functional capacity, and cardiovascular function were significantly improved, while heart failure hospitalization days were significantly reduced in Barostim Therapy patients compared to control patients. The favorable data are now published in JACC-HF and European Journal of Heart Failure.¹ ²
About the BeAT-HF Phase III Clinical Trial
The BeAT-HF Phase III clinical trial is designed to demonstrate the safety of Barostim neo and its effectiveness on symptoms and clinical outcomes in patients suffering from chronic heart failure. The trial is intended to provide the basis for market approval in the US. Key provisions of the EAP designation intended to streamline the clinical trial could accelerate this process by up to one to two years.
Key Eligibility Criteria:
- NYHA Class III
- Left Ventricular Ejection Fraction ≤ 35%
- Elevated NTproBNP
- On current heart failure guideline directed therapy
About Barostim neo®
Barostim neo is a second-generation device that uses CVRx-patented technology 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 electrically activates the baroreflex, the body’s natural mechanism to regulate cardiovascular function. By activating this afferent pathway, Barostim Therapy reduces sympathetic activity and increases parasympathetic activity, ultimately restoring autonomic balance.
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, as therapy can be turned off
- It provides 100 percent adherence to treatment by continuously activating the baroreflex
- It is compatible with and complementary to implantable cardiac rhythm management devices³
- It is now MR Conditional, or safe for use under specified conditions in Europe.
About Heart Failure
Heart failure is a serious condition that impairs heart function, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.1 million adults.4 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, Minnesota. The company has developed the second-generation Barostim neo, a minimally-invasive implantable system and the only device CE Marked for the separate indications of heart failure and resistant hypertension. Barostim neo is commercially available in over 20 countries and under clinical evaluation for the treatment of heart failure, hypertension, and chronic kidney disease in the United States. It is now MR Conditional, or safe for use under specified conditions in Europe. The company’s Barostim neo legacy™, holds Humanitarian Device Exemption (HDE) approval from the FDA, deeming it safe for use in hypertensive patients who were responders to the first-generation Barostim Therapy with Rheos Carotid Sinus Lead System.
1. Abraham W, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction, JACC: Heart Failure 2015; 3(6):487-496
2. Zile M, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction: Safety and Efficacy in Patients with and without Cardiac Resynchronization Therapy, European Journal of Heart Failure (2015), doi: 10.1002/ejhf.299
3. Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrillator: Compatible, complementary therapies. Europace Feb, 2014
4. 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. 2015. All rights reserved.
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