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 heart failure, announced that a study assessing its MobiusHD device to treat patients with chronic heart failure has been published in the peer-reviewed journal, Structural Heart.
The findings and clinical meaningfulness assessments 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 the First-in-Human Results.”
The authors conclude that the MobiusHD device implantation in progressive heart failure patients, who had previously remained highly symptomatic despite guideline-directed medical therapy, was safe and resulted in clinically meaningful improvements in health status, functional exercise capacity, NT-proBNP levels, and left ventricular ejection fraction (LVEF) changes that emerged within three months after device implantation and were sustained through 12 months follow-up in the feasibility clinical trial.
“The clinical results of this feasibility study have shown impressive efficacy," said JoAnn Lindenfeld, MD, a 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 experienced positive changes in quality of life and exercise capacity is encouraging, and we look forward to learning more in the forthcoming pivotal study further examining this promising technology."
The endovascular baroreflex amplification (EVBA) procedure enables placement of the 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 unique MobiusHD device mechanically stimulates the arterial baroreceptor reflex by changing the geometric shape of the carotid sinus to increase local arterial wall stretch while preserving pulsatility. 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 results from this published study further validate and add to the evidence supporting the potential value of the MobiusHD technology, as a potential game-changer for chronic heart failure sufferers who have not responded well to traditional treatments, despite being 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. Also, a pivotal clinical trial is planned and will include a sham-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 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.