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Vascular Dynamics Reports: Positive Preliminary Clinical Trial Results Reported for Their Novel Heart Failure Treatment Technology

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February 9, 2021

Vascular Dynamics, Inc. 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.”

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
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