Two-Year Study Data for EVBA Procedure with Unique MobiusHD Device Presented at Technology and Heart Failure Therapeutics Meeting
IRVINE, CA – March 22, 2023
Vascular Dynamics, Inc. (VDI), a privately held medical device company focused on developing game-changing endovascular device-based solutions for patients suffering from heart failure, announced that two-year results from a study assessing its MobiusHD device to treat patients with chronic heart failure were presented today at the Technology and Heart Failure Therapeutics (THT) 2023 meeting in Boston.
The data, presented by JoAnn Lindenfeld, MD, a heart failure specialist at Vanderbilt University Medical Center and Past President of the Heart Failure Society of America, focused on the efficacy of the MobiusHD device implantation in progressive heart failure patients who were previously highly symptomatic despite guideline-directed medical therapy. In her presentation, titled “Long-Term Outcomes of Endovascular Baroreflex Amplification in Symptomatic Patients with HFrEF,” Dr. Lindenfeld reported that the device and procedure have shown sustained two-year improvements in patient-centered outcomes including KCCQ scores, 6MWD and NYHA class accompanied by improvements in LVEF and NT-proBNP. These results provide evidence suggesting a clinically meaningful and durable benefit of endovascular baroreflex amplification (EVBA) in specific heart failure patients.
“The clinical results have shown impressive efficacy in this feasibility study,” said Dr. Lindenfeld. “That all patients underwent successful and uneventful device implantation and experienced positive changes in quality of life and exercise capacity at two years out is encouraging. We look forward to learning more in the forthcoming pivotal study further examining this promising technology.”
Earlier in the week at THT, Horst Sievert, MD, Director of the CardioVascular Center in Frankfurt, described the MobiusHD device and the EVBA procedure while sharing data from the first 33 patients treated for heart failure using the approach.
“EVBA therapy utilizing the MobiusHD technology provides a straightforward approach using established catheter-based techniques,” said Dr. Sievert. “Our experience with this mechanical approach to barostimulation has been safe and shown impressive results.”
The EVBA procedure enables placement of the unique MobiusHD implant in the targeted site within the carotid sinus. After identifying the preferred target location using pre-procedure imaging, the procedure is typically completed in less than 30 minutes. The MobiusHD device mechanically stimulates the arterial baroreceptor reflex by changing the geometric shape of the carotid sinus to increase local arterial wall stretch. The resulting amplified nerve signaling triggers decreasing sympathetic activity and increasing parasympathetic activity. This rebalancing of the autonomic nervous system is believed to improve symptoms and prevent progression of HFrEF. In this way, the MobiusHD offers a potential device-based solution for symptomatic heart failure patients who are not responding to drug treatment.
“The data shared at this year’s THT conference by Dr. Lindenfeld and Dr. Sievert further validate and enhance the evidence supporting the potential value of the MobiusHD technology, as a potential breakthrough for patients with chronic heart failure who suffer, despite being well-medicated,” said Ed Roschak, CEO of Vascular Dynamics. “We look forward to the forthcoming pivotal clinical trial which will be a randomized sham-controlled study.”
“MobiusHD” is a registered trademark of Vascular Dynamics, Inc.
Note: In the United States, the MobiusHD device is limited by law to investigational use only.
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.