Vascular Dynamics’ MobiusHD Studied for Endovascular Baroreflex Amplification to Treat Chronic HF Patients

October 18, 2022—Vascular Dynamics, Inc. announced the publication of a study assessing its MobiusHD device to treat patients with chronic heart failure (HF).

The company stated that the MobiusHD may provide a potential device-based solution for symptomatic HF patients who are not responding to drug treatment by rebalancing of the autonomic nervous system, which is believed to improve symptoms and prevent progression of HF with reduced ejection fraction (HFrEF).

The study investigators evaluated the endovascular baroreflex amplification procedure, which is intended to enable placement of the MobiusHD implant in the targeted site within the carotid sinus. After identifying the preferred target location using preprocedure imaging, the procedure is typically completed in < 30 minutes.

Kerstin Piayda, MD, et al published the findings and clinical meaningfulness assessments from this interim analysis of the first-in-human study online in Structural Heart.

According to Vascular Dynamics, the 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.

As summarized in the company’s press release, the investigators concluded that the MobiusHD device implantation in progressive HF 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, N-terminal pro–B-type natriuretic peptide levels, and left ventricular ejection fraction changes that emerged within 3 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,” commented study investigator JoAnn Lindenfeld, MD, in the company’s press release. “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.” Dr. Lindenfield is an HF specialist at Vanderbilt University Medical Center in Nashville, Tennessee.

Ed Roschak, CEO of Vascular Dynamics, stated in the press release, “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 HF sufferers who have not responded well to traditional treatments, despite being well-medicated. 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.”