Vascular Dynamics Inc.

Reshaping Hypertension

Vascular Dynamics Inc. (VDI) is a medical device company focused on innovative, minimally invasive device-based solutions for patients at risk of life-threatening cardiovascular conditions and underserved by conventional treatments. VDI is sponsoring an FDA-approved clinical trial, the CALM-2 study, of the novel endovascular baroreflex amplification (EVBA) procedure using the MobiusHD® device as a treatment for drug-resistant hypertension.

*Caution: Investigational device. Limited by United States law to investigational use.

Vascular Dynamics Inc.

Reshaping Hypertension

Vascular Dynamics Inc. (VDI) is a medical device company focused on innovative, minimally invasive device-based solutions for patients at risk of life-threatening cardiovascular conditions and underserved by conventional treatments. VDI is sponsoring an FDA-approved clinical trial, the CALM-2 study, of the novel endovascular baroreflex amplification (EVBA) procedure using the MobiusHD® device as a treatment for drug-resistant hypertension.

*Caution: Investigational device. Limited by United States law to investigational use.

Vascular Dynamics Inc.

Reshaping Hypertension

Vascular Dynamics Inc. (VDI) is a medical device company focused on innovative, minimally invasive device-based solutions for patients at risk of life-threatening cardiovascular conditions and underserved by conventional treatments. VDI is sponsoring an FDA-approved clinical trial, the CALM-2 study, of the novel endovascular baroreflex amplification (EVBA) procedure using the MobiusHD® device as a treatment for drug-resistant hypertension.

*Caution: Investigational device. Limited by United States law to investigational use.

Vascular Dynamics Inc.

Reshaping Hypertension

Vascular Dynamics Inc. (VDI) is a medical device company focused on innovative, minimally invasive device-based solutions for patients at risk of life-threatening cardiovascular conditions and underserved by conventional treatments. VDI is sponsoring an FDA-approved clinical trial, the CALM-2 study, of the novel endovascular baroreflex amplification (EVBA) procedure using the MobiusHD® device as a treatment for drug-resistant hypertension.

*Caution: Investigational device. Limited by United States law to investigational use.

Featured Presenters

Gregg W. Stone, MD, FACC, FSCAI
Co-Principal Investigator of CALM-2 study

Professor of Medicine at the Columbia University Medical Center, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital, and Co-Director of Medical Research and Education at the Cardiovascular Research Foundation in New York, NY.

George L. Bakris, MD, MA, Hon. DSc, F.A.S.H, F.A.S.N., F.A.H.A.

Professor of Medicine and Director of the AHA Comprehensive Hypertension Center in the Department of Medicine at the University of Chicago Medicine

William A. Gray, M.D. FACC FSCAI

System Chief, Division of Cardiovascular Diseases of Main Line Health President, Lankenau Heart Institute

Featured Videos

A Patient Success Story: After the MobiusHD® Video

A Patient Success Story: After the MobiusHD®

A MobiusHD®* patient shares her story with high blood pressure and her experience with the Mobius HD® implant procedure.

The MobiusHD®: Controlling Uncontrollable Blood Pressure Video

The MobiusHD®: Controlling Uncontrollable Blood Pressure

Bryan Williams MD, one of the co-principal investigators of the CALM-2 Study explains how the MobiusHD®* may help adults affected with high blood pressure that medication is unable to control.

Managing Hypertension with the MobiusHD® Video

Managing Hypertension with the MobiusHD®

Gregg Stone MD, one of the co-principal investigators of the CALM-2 Study shares his thoughts on managing hypertension using the MobiusHD®*.

Studying Treatment Resistant Hypertension Video

Studying Treatment Resistant Hypertension

Chandan Devireddy MD, discusses endovascular baroreflex amplification (EVBA) which is a study of the investigational MobiusHD®* device for the potential safety and efficacy of lowering blood pressure.

Hypertension

Over 100 million people in the U.S. have hypertension which is recognized as the most important single risk factor for cardiovascular morbidity and death. People with high blood pressure have three to four times higher, often life-threatening, risks of heart disease and stroke. For about half of all people with hypertension, medication regimens are ineffective in providing sustainable blood pressure control. Additionally, about one in ten of treated patients will have refractory or resistant hypertension where blood pressure remains uncontrolled despite taking at least three anti-hypertensive medications.

Treatments

Device-based treatments, such as EVBA with the MobiusHD® implant, may be able to provide effective solutions for patients who have not benefited from medication regimens. Vascular Dynamics developed the first minimally invasive technology that utilizes the body’s natural blood pressure control system, the baroreceptor mechanism or baroreflex, to address uncontrolled hypertension. Baroreceptors are specialized nerves located in the carotid artery which detect changes in stretch of the arterial wall and signal the brain to control blood pressure. The MobiusHD® is a thin, self-expanding rectangular device that reshapes the carotid sinus following its endovascular implantation. It is intended to amplify the baroreflex while maintaining normal blood flow and pulsatility.

*Caution: Investigational device. Limited by United States law to investigational use.

Results

Results for EVBA published in The Lancet from an open-label, proof-of-concept trial (CALM-FIM) were positive showing significant reductions in blood pressure through six months. The reductions in 24-hour ambulatory blood pressure were greater than those recently reported for alternative, second-generation device-based approaches to treat hypertension. These encouraging results led to the design and development of a rigorous pivotal clinical trial design intended to generate conclusive evidence confirming the safety and efficacy of this unique device for resistant hypertension patients.



Take Action

The CALM-2 (Controlling and Lowering Blood Pressure with MobiusHD®) pivotal trial includes a prospective, randomized, sham-controlled, double-blinded study design targeting patients with drug resistant hypertension. Lessons learned from numerous clinical trials of first generation device-based approaches to hypertension were incorporated into the CALM-2 study protocol to provide a best-in-class clinical trial design. The CALM-2 trial is targeting enrollment of up to 300 patients at leading institutions across the U.S. and Europe.

*Caution: Investigational device. Limited by United States law to investigational use.

*Caution: Investigational device. Limited by United States law to investigational use.