MINNEAPOLIS, Oct. 6, 2016 /PRNewswire/ -- CVRx, Inc., a private medical device company, today announced the appointment of Tom Moore to the newly created, officer position of Vice President, U.S. Market Development. In this role, Mr. Moore will lead all field efforts related to the successful completion of the Baroreflex Activation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF). In addition, Mr. Moore will lead all market development activities critical to preparing the U.S. market for a successful commercial launch after FDA approval.
"We are really excited to bring Tom back to CVRx in this key leadership role. Tom's track record in leading the successful enrollment in the Rheos Pivotal Trial for the treatment of hypertension as well as the Phase II HOPE4HF feasibility study for the BAROSTIM NEO® device for the treatment of heart failure gives us further confidence in the timely enrollment of the BeAT-HF clinical trial," said Nadim Yared, President and CEO of CVRx.
Mr. Moore began his career at Medtronic where he held leadership roles in the areas of marketing and sales in the neuromodulation businesses. He brings 20 years of global market development experience to CVRx. Most recently he was the President of a medical start-up company focused on urological disorders. Mr. Moore holds a master's degree from The Carlson School of Management at the University of Minnesota and a bachelor's degree in Business from the University of Colorado.
About the BeAT-HF Pivotal 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 United States.
Key Eligibility Criteria:
- NYHA Class III
- Left Ventricular Ejection Fraction ≤ 35%
- Elevated NTproBNP
- On current heart failure guideline-directed medical therapy
About BAROSTIM THERAPY™ for Heart Failure
Positive safety and efficacy results from HOPE4HF, a 146-patient randomized, controlled clinical trial were presented at the American College of Cardiology, Heart Rhythm Society and the European Society of Cardiology Heart Failure conference in 2015. Results at six months showed that patient symptoms, functional capacity, and cardiovascular function were significantly improved, while heart failure hospitalization days were 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 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. BAROSTIM NEO is also a treatment option for patients with resistant hypertension. The BAROSTIM NEO System 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.
Key unique benefits:
- BAROSTIM NEO ensures 100 percent adherence to treatment
- It continuously stimulates the baroreflex, and can be adjusted to meet each patient's individual therapeutic needs
- It is compatible with, and complementary to, implantable cardiac rhythm management devices3
- It is a reversible treatment, as therapy can be turned off
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 2013.4
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 and hypertension in the United States. The company's BAROSTIM NEO LEGACY™ holds Humanitarian Device Exemption (HDE) approval from FDA, deeming it safe for use in hypertensive patients who were responders to the first-generation BAROSTIM THERAPY with Rheos Carotid Sinus Lead System.
- 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
- 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
- Madershahian N, et al. Baroreflex activation therapy in patients with preexisting implantable cardioverter-defibrillator: Compatible, complementary therapies. EuropaceFeb, 2014
- 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. 2016. All rights reserved
SOURCE CVRx, Inc.