IRVINE, Calif.–(BUSINESS WIRE)–Vascular Dynamics, Inc. (VDI), a private medical device company focused on developing breakthrough endovascular device-based solutions for patients with heart failure, announced that a study evaluating its MobiusHD device for treating patients with heart failure chronicle was published in the peer-reviewed journal, structural core.
Results and assessments of clinical significance are reported by interventional and cardiovascular surgeons in the article, “Endovascular Baroreflex Amplification with the MobiusHD Device in Patients with Heart Failure and Reduced Ejection Fraction: Interim Analysis of First-in-Human Results.”
The authors conclude that implantation of the MobiusHD device in patients with progressive heart failure, who had previously remained highly symptomatic despite medical treatment according to guidelines, was safe and resulted in clinically meaningful improvements in health status, functional exercise capacity, NT-proBNP levels and left. Changes in ventricular ejection fraction (LVEF) that appeared within three months of device implantation and were maintained through 12 months of follow-up in the clinical feasibility trial.
“The clinical results of this feasibility study showed impressive efficacy,” said JoAnn Lindenfeld, MD, heart failure specialist at Vanderbilt University Medical Center, and one of the study’s co-authors. “That all patients underwent successful and uneventful device implantation and the positive changes experienced in quality of life and exercise capacity are encouraging, and we look forward to learning more in the upcoming pivotal study examining more this promising technology in detail.”
The Endovascular Baroreflex Amplification (EVBA) procedure allows placement of the MobiusHD implant in the targeted site in the carotid sinus. After identifying the preferred target location using pre-procedure imaging, the procedure is typically completed in less than 30 minutes.
The unique MobiusHD device mechanically stimulates the arterial baroreceptor reflex by modifying the geometric shape of the carotid sinus to increase local stretch of the arterial wall while preserving pulsatility. The resulting amplified nerve signaling triggers a decrease in sympathetic activity and an increase in parasympathetic activity. This rebalancing of the autonomic nervous system is thought to improve symptoms and prevent the progression of HFrEF. In this way, the MobiusHD offers a potential device-based solution for patients with symptomatic heart failure who are unresponsive to drug treatment.
“The results of this published study validate and add to the evidence supporting the potential value of MobiusHD technology, as a potential game-changer for people with chronic heart failure who have not responded well to treatments. traditional, albeit well-medicated,” commented Ed Roschak, CEO of Vascular Dynamics. “We look forward to advancing our evaluations in this ongoing study, including patients from Canada, Australia and Germany. In addition, a pivotal clinical trial is planned and will include a simulation-controlled randomized study protocol. »
“MobiusHD” is a registered trademark of Vascular Dynamics, Inc.
About Vascular Dynamics, Inc.
Vascular Dynamics develops innovative endovascular platform technologies to provide compelling treatment options for patients at risk of life-threatening diseases underserved by conventional treatments. The Company’s MobiusHD technology includes 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 ongoing. More information is available at www.vasculardynamics.com.