IRVINE, Calif.--(BUSINESS WIRE)--Vascular Dynamics, Inc. (VDI), a privately held medical device company focused on developing game-changing endovascular device-based solutions for patients suffering from cardiovascular conditions, has announced that encouraging early results for its heart failure clinical trial have been presented. The company has also announced the addition of Stan Rabinovich to its Board of Directors.
At this week’s EuroPCR meeting, data from VDI’s clinical trial, “A Feasibility Study Exploring the Effect of the MobiusHD® Device in Patients with Heart Failure” were reported. An endovascular approach is used to implant VDI’s MobiusHD device, targeting baroreceptor sensory neurons which respond to stretching and are located along the carotid arteries in the neck. The MobiusHD device is designed to amplify the natural baroreflex mechanism signaling the brain to produce therapeutic modulation of the autonomic nervous system. An autonomic nervous system imbalance is an underlying pathogenesis of heart failure.
Horst Sievert, MD, Director of the CardioVascular Center in Frankfurt, reported that 19 heart failure patients with reduced ejection fraction (HFrEF) were safely and successfully treated using the endovascular procedure with the MobiusHD device. Three-month data for these patients were presented, and all 19 patients demonstrated impressive, clinically meaningful improvement. Statistically significant improvements at three-months compared to baseline in Kansas City Cardiomyopathy Questionnaire scores, six-minute hallway walk distances, NT-proBNP levels, and left ventricular echocardiography parameters were reported.
"These initial clinical results have shown impressive efficacy and demonstrated that the MobiusHD device provides a safe option to treat heart failure patients," said Dr. Sievert. "We have more work to do to establish longer-term efficacy, but these data are further evidence that placing the MobiusHD device in the carotid artery can be done safely."
VDI plans to continue treating appropriate heart failure patients at centers around the world while engaging the FDA to define the parameters for a pivotal IDE clinical trial in the US.
The report of the clinical trial results is accompanied by news that Stan Rabinovich has joined the VDI Board of Directors. Rabinovich has a remarkable track record in the development and commercialization of disruptive innovations. He brings to VDI a unique perspective based on his extensive endovascular device expertise spanning 40 years. His pioneering efforts include the development of coronary stents, drug-eluting stents, and transcatheter heart valves. He was a co-founder of Percutaneous Valve Technologies, Inc. (PVT) which was subsequently acquired in 2004 by Edwards Lifesciences. While at Edwards, he was focused on technologies, applications, and business alliances related to structural heart disease as Vice President of Advanced Technology and Discovery. In 2018, Rabinovich received the Innovator Award at the 25th Annual Phoenix Medical Device Conference.
“We are thrilled to have Stan join our team,” said Ed Roschak, VDI’s CEO. “His engagement with us is particularly well timed as we continue to gather encouraging early clinical results from our feasibility study in heart failure patients. We are expanding our efforts to clinical centers around the world. Additional results will be reported 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 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 are in progress. More information is available at www.vasculardynamics.com.