Positive Preliminary Clinical Trial Results Reported for Vascular Dynamics’ Novel Heart Failure Treatment Technology
Endovascular baroreflex modulation data presented
Feb 9, 2021
IRVINE, CALIF – (February 9, 2021) – Vascular Dynamics, Inc., a privately held medical device company focused on innovative, endovascular device-based solutions for cardiovascular conditions, has announced positive preliminary results from its clinical trial, “A Feasibility Study Exploring the Effect of the MobiusHD® Device in Patients with Heart Failure.”
Horst Sievert, MD, Director of the CardioVascular Center in Frankfurt, Germany and Tamaz Shaburishvili, MD, Head of the Cardiovascular Clinic at Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia shared preliminary results of the clinical trial as part of a CSI Focus D-HF webinar presented last week.
Baroreceptors are specialized nerve endings that respond to stretch and are located along the carotid arteries in the neck. These stretch receptors are essential to the body’s natural control of the cardiovascular system and its performance. The MobiusHD device is a carotid endovascular implant designed to amplify this natural baroreflex mechanism, signaling the brain to produce autonomic modulation for improved heart function.
EndoVascular Baroreflex Amplification (EVBA) is the procedure used to implant the MobiusHD device. EVBA has been previously evaluated successfully in the treatment of 89 hypertension patients. EVBA using the MobiusHD device is now being investigated as a treatment to help patients suffering with heart failure.
Prof. Sievert reported that 19 heart failure patients with reduced ejection fraction (HFrEF) were safely and successfully treated using the EVBA procedure with the MobiusHD device. Preliminary data from the three-month follow up were presented for the first 13 of these patients. Every patient demonstrated clinical improvement. Statistically significant changes in averages of Kansas City Cardiomyopathy Questionnaire scores, six-minute hallway walk distances, NT-proBNP levels, and left ventricular ejection fractions were reported.
“We are very excited about such positive initial results,” said Sievert. “The procedure is straightforward, using conventional carotid access techniques, and is very safe. The early results are impressive and point to a potential solution for appropriate heart failure patients. Further evaluation is recommended.”
“Preliminary results from this feasibility study in heart failure patients are very promising,” commented Ed Roschak, CEO of Vascular Dynamics. “We look forward to expanding these efforts to multiple clinical centers around the world. We will report additional results as they become available.”
About Vascular Dynamics, Inc.
Vascular Dynamics develops innovative, endovascular platform technologies to offer compelling treatment options for patients at risk of life-threatening conditions and underserved by conventional treatments. The company’s MobiusHD technology features the first endovascular device to use the body’s natural baroreflex mechanism to modulate the autonomic nervous system and help restore sympathetic balance. Clinical evaluations of this unique baroreflex modulation therapy for heart failure and high-risk hypertensive patients are in progress. More information is available at www.vasculardynamics.com.
CAUTION: In the United States, the MobiusHD® device is limited by law to investigational use only.