News release: CVRx® Receives FDA Approval for World’s First Heart Failure Neuromodulation Device

BAROSTIM NEO™ provides significant clinical benefit to heart failure patients

MINNEAPOLIS, Aug. 16, 2019 /PRNewswire/ — CVRx, Inc., a private medical device company, announced today that it has received Premarket Approval (PMA) from the United States Food and Drug Administration (FDA) to market its BAROSTIM NEO device for heart failure in the United States. The FDA’s Center for Devices and Radiological Health (CDRH) approved the Company’s submission after a thorough review of the clinical trial data from the Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF).

“With the FDA’s approval of the BAROSTIM NEO, we finally have an effective neuromodulation therapy for advanced heart failure patients who are not indicated for Cardiac Resynchronization Therapy (CRT),” said Michael Zile, M.D., Professor of Medicine at the Medical University of South Carolina and Chair Person of the BeAT-HF Executive Steering Committee. “The BAROSTIM NEO improves the quality of life and the exercise capacity of heart failure patients who previously did not have access to a device-based therapy.”

Designed to address a significant unmet medical need in heart failure with reduced ejection fraction, the BAROSTIM NEO was one of the first therapies to receive the FDA’s “Breakthrough Device” designation. The “Breakthrough Device” designates therapies that offer a more effective treatment for life-threatening or irreversibly debilitating diseases. As a result of the BAROSTIM NEO receiving this designation, the BeAT-HF Trial received prioritized review by the FDA, which helped accelerate the development and approval process, resulting in expedited patient access to the Company’s unique therapy.

“After many decades of research in the field of neuromodulation, the BAROSTIM NEO is the first device approved in the United States that uses the power of the brain and nervous system to target cardiovascular disease,” said Nadim Yared, President and CEO of CVRx. “We are thrilled to transition to the next stage of our company’s growth, shifting our focus to the successful adoption of BAROSTIM NEO in the United States and bringing an innovative solution to chronic heart failure patients.”

About the BeAT-HF Pivotal Randomized Controlled Trial
The BeAT-HF phase III randomized clinical trial confirmed the safety of BAROSTIM NEO and its effectiveness in improving symptoms in patients suffering from chronic heart failure. The trial analysis included results from 264 patients randomized to two arms: 130 subjects randomized to receive a BAROSTIM NEO were compared to 134 subjects randomized to stay on guideline-directed medical therapy. The positive safety and effectiveness results were presented in Late Breaking Clinical Trial sessions at the Heart Rhythm Society and the European Society of Cardiology Heart Failure conferences in May 2019.

Key BeAT-HF Trial Eligibility Criteria:

  • NYHA Class III or Class II (with recent history of Class III)
  • Left ventricular ejection fraction ≤ 35%
  • On current heart failure guideline-directed medical therapy
  • NT-proBNP < 1600 pg/mL
  • Excluded patients indicated for CRT according to AHA/ACC/ESC guidelines

Key Results:

  • BAROSTIM NEO is safe to use for patients in heart failure with reduced ejection fraction
  • BAROSTIM NEO demonstrated clinically significant improvements in patient-centered symptomatic endpoints as compared to the control group:
    • Improved their quality of life score by 14 points using the Minnesota Living with Heart Failure Questionnaire,
    • Improved their exercise capacity by 60 meters as measured by the standardized 6-minute hall walk test, and
    • Improved their functional status as assessed by their NYHA classification.
  • These results were supported by objective evidence of significant reduction of NT-proBNP.
  • These clinically significant differences in treatment effect were observed despite an increase in the number of medications in the control arm.

Supporting Evidence 
Positive BAROSTIM NEO safety and efficacy results were previously reported from HOPE4HF, a 146-patient randomized, controlled phase II clinical trial. Results at six months showed that quality of life, 6-minute hall walk test and cardiovascular function were significantly improved in BAROSTIM NEO patients compared to control patients. Results were published in JACC-HF and European Journal of Heart Failure.1, 2

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 6.5 million adults.3 Overall, heart failure was associated with one in 8 deaths and close to half the people that develop heart failure die within 5 years of diagnosis.3 Projections suggest that by 2030, the total cost of heart failure will increase to $69.7 billion.3

About BAROSTIM NEO
BAROSTIM NEO uses CVRx-patented technology designed to trigger the body’s main cardiovascular reflex to treat patients suffering from chronic heart failure. It is designed to electrically activate 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.

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 approved for use in heart failure in over 30 countries and approved for use in resistant hypertension in the European Economic Area, Colombia and New Zealand.

Footnotes:

  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. Eur J Heart Fail. 2015;17(10):1066-1074.
  3. Benjamin EJ, et al. Heart Disease and Stroke Statistics—2018 Update. Circulation. 2018;137:e67–e492.

News release: CVRx® Announces Expedited Access Pathway Designation by FDA

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.

CVRx Contacts

John Brintnall
Chief Financial Officer
jbrintnall@cvrx.com
Phone: 763.416.2853

Tom Moore
Vice President of Sales Operations, Market Development, and the Americas
tmoore@cvrx.com
Phone: 763.258.9039

Footnotes:

  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.