Utrecht (The Netherlands), Cambridge (United States) – Gilde Healthcare company CVRx, Inc., announces today that it 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 BAROSTIM NEO is the world’s first FDA approved heart failure neuromodulation device. 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
- 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.
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.
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 $69.7 billion.
About BAROSTIM NEO
BAROSTIM NEO uses CVRx-patented technology designed to trigger the body’s main cardiovascular reflex to treat patients suffering from chronic heart failure. It is designed to electrically activate the baroreflex, the body’s natural mechanism to regulate cardiovascular function. By activating this afferent pathway, BAROSTIM therapy reduces sympathetic activity and increases parasympathetic activity, ultimately restoring autonomic balance.
About CVRx, Inc.
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis, Minnesota. The company has developed the second-generation BAROSTIM NEO, a minimally invasive implantable system approved for use in heart failure in over 30 countries and approved for use in resistant hypertension in the European Economic Area, Colombia and New Zealand.
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing € 1 billion ($ 1.2 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in health tech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com.
Gilde Healthcare IV is supported by the European Recovery Program – EIF facility.