News | Hypertension | February 20, 2019

St. Bartholomew's Hospital Initiates CALM-2 Hypertension Trial

Trial seeks to confirm initial results for MobiusHD endovascular device for treatment of high blood pressure

St. Bartholomew's Hospital Initiates CALM-2 Hypertension Trial

February 20, 2019 — California-based Vascular Dynamics Inc. (VDI) is sponsoring a new clinical trial, called CALM-2 (Controlling And Lowering blood pressure with MobiusHD), of a novel endovascular approach to treat patients with drug-resistant hypertension. St. Bartholomew’s Hospital in London is helping to lead efforts in the U.K. as a key study site.

High blood pressure, or hypertension, is recognized as the most important single risk factor for cardiovascular morbidity and death. Despite advances in the effectiveness of medications, many struggle to control their blood pressure to targeted levels, despite antihypertensive medications. In fact, half of patients treated with medications for high blood pressure have uncontrolled hypertension. For these people and their loved ones, the need for a non-pharmaceutical treatment has become of critical importance.

Specialized stretch-sensitive nerves, called baroreceptors, are located in the walls of the carotid arteries and play an essential role in the body’s natural blood pressure regulation. Vascular Dynamics has developed the first catheter-based, non-surgical approach that utilizes the baroreceptor mechanism to address uncontrolled hypertension. This approach includes placement of the MobiusHD implant, a thin rectangular-shaped device designed to reshape the carotid sinus to increase baroreceptor stretch and amplify nerve signaling to the brain. This serves to reduce blood pressure while maintaining normal blood flow and beat-to-beat fluctuations.

The MobiusHD device was studied in an earlier proof-of-concept study, and results were published in 2017, showing significant reductions in blood pressure through six months after implantation. These encouraging results led to the design of the larger multi-center clinical trial, CALM-2, intended to generate definitive evidence of safety and effectiveness of this approach.

“The consequences of high blood pressure represent a tremendous unmet clinical need, and a non-pharmaceutical solution is needed,” said principal investigator Prof. Melvin Lobo from Queen Mary University of London and Barts Health NHS Trust, which runs St Bartholomew’s Hospital. “The initial results using the MobiusHD implant to reshape the carotid sinus and stretch baroreceptors to trigger the body’s natural blood pressure regulation is impressive and of great interest to us. The safety and efficacy for this approach must be confirmed in a larger clinical trial, and we look forward to being an integral part of this important study.”

Enrollment for the CALM-2 study has begun at select medical centers around the U.K., Europe and the U.S.

For more information: www.vasculardynamics.com

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