First German EVBA Procedure is Performed with New Heart Failure Therapy Approach

Latest Data and Live Broadcast Show Promise of Vascular Dynamics’ MobiusHD Device

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 the endovascular baroreflex amplification (EVBA) procedure using its MobiusHD device to treat patients with heart failure was featured during last month’s CSI Frankfurt 2022 25^th anniversary Congress.

The first German EVBA procedure treating heart failure was performed by Horst Sievert, MD, Director of the CardioVascular Center in Frankfurt, and was broadcast live during the meeting. Dr. Sievert stated that the placement in this case, while using established, relatively straightforward techniques, was “perfect.” This case also represented the 30^th patient enrolled in the ongoing clinical trial titled, “A Feasibility Study Exploring the Effect of the MobiusHD Device in Patients with Heart Failure.”

The EVBA approach allows for precise placement of the MobiusHD implant in the pre-procedurally targeted location where baroreceptors are located along the carotid body. The technique can be completed in less than 30 minutes and offers a potential solution for symptomatic heart failure patients who are not responding to drug treatment.

CSI Education has selected the live case to be recognized as its “Podcase of the Month,” and it can be viewed here.

Also during the CSI Frankfurt meeting, Kerstin Piayda, MD of the CardioVascular Center in Frankfurt, presented updated results from the clinical trial. Improvements in outcomes for patients receiving EVBA treatment with the MobiusHD device including 3-, 6-, and 12-month follow-up were reported. Based on the results of quality of life, six-minute walk distance (6MWD), and NT-proBNP biomarker measurements, almost all of the study patients had positive responses at 12 months (90% with improved quality of life and 100% showed improvements in 6MWD and NT-proBNP levels), and a high percentage benefited from what were considered to be clinically meaningful results. Dr. Piayda also shared data reflecting the promising trend of reduced heart failure hospitalization for these patients after treatment at 6 and 12 months.

“Results to date from the feasibility study in heart failure patients have been very promising,” commented Ed Roschak, CEO of Vascular Dynamics. “With our recently announced $20 million financing round, we are currently expanding these efforts to multiple clinical centers around the world and are continuing to enroll more patients.”

"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.