News | Hypertension | August 15, 2017

Vascular Dynamics to Initiate U.S. Trial for MobiusHD System for Resistant Hypertension

Transcatheter device designed to amplify the signals received by carotid artery baroreceptors

The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.

Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc. (VDI) investigational device exemption (IDE) study so it can initiate its pivotal trial for its MobiusHD System for the treatment of resistant hypertension.

The CALM (Controlling and Lowering Blood Pressure with MobiusHD) 2 trial is a multi-center, prospective, randomized, double-blind, sham-controlled pivotal study designed to evaluate the safety and effectiveness of the MobiusHD System. The company will evaluate patients from select locations throughout the United States whose hypertension remains uncontrolled despite using three or more anti-hypertensive pharmacologic therapies.  VDI also intends to conduct the CALM 2 trial in certain European countries following appropriate regulatory authorization.

“The rigor and scientific focus of the Calm 2 trial has been crafted and improved from much of what we learned from prior studies. Calm 2 will offer patients a therapeutic alternative and a level of medical monitoring to which they otherwise would never have access outside of a clinical trial,” said Bryan Williams, co-principal investigator of the Calm 2 trial and chair of medicine at University College London, He is also director of the NIHR UCLH/UCL Biomedical Research Centre and director of research at UCL Hospitals. He is chairman-elect of the European Council on Hypertension of the European Society of Cardiology.

“In clinical practice, we are regularly faced with those hypertension patients who simply do not respond to medication or lifestyle changes,” said Gregg Stone, M.D., co-principal investigator of the CALM 2 trial and director of cardiovascular research and education for Columbia University Medical Center/New York-Presbyterian Hospital, and co-director of medical research and education at the Cardiovascular Research Foundation. “Initiating this trial is an important step toward identifying additional viable treatments to help this large population of patients.”  

The company has been chosen as a participant in the FDA’s Expedited Access Pathway (EAP) program, a focused initiative to significantly accelerate access for US patients and their physicians to innovative medical treatments. VDI is also one of only nine companies chosen for the FDA’s Early Feasibility Study Investigational Device Exemptions (IDE) Pilot Program, which enables companies to conduct smaller-scale studies under the guidance of the agency in the United States in order to meet the requirements for an earlier pathway toward approval.

The MobiusHD System, a minimally-invasive system, capitalizes on the ability of the body’s baroreceptor mechanism to regulate blood pressure. Baroreceptors are receptors located in the carotid artery that sense blood pressure and relay that information to the brain. The MobiusHD implant is designed to amplify the signals received by the surrounding arterial baroreceptors, and thereby increase the body’s natural response to lower blood pressure through vasodilation.

The MobiusHDsystem has received a CE mark for the treatment of hypertension in the European Union. The MobiusHD system is not commercially available in the United States.
 

About Resistant Hypertension

Hypertension, or elevated blood pressure, is a common medical condition that currently affects one billion people worldwide.[1] If left untreated, hypertension can cause life-threatening problems, including heart attack, aneurysm, stroke or kidney failure. Patients with hypertension can often reduce their risk factors by making lifestyle changes such as losing weight, quitting smoking, and increased exercise. In cases with advanced hypertension, medical therapies may be prescribed.

Resistant hypertension cannot be controlled with medical therapies. Patients experiencing resistant hypertension are at four times greater risk of cardiovascular events compared with hypertensive patients achieving blood pressure targets.[2] The American Heart Association (AHA) estimates that high blood pressure costs the U.S. $46 billion each year, including the cost of healthcare services, medications to treat high blood pressure and lost productivity.

For more information: www.vasculardynamics.com

Read the article “Vascular Dynamics Completes $10.4 Million Financing for Novel Hypertension Device.”

Watch the VIDEO “Device Therapies to Treat Hypertension,” an interview with Krishna Rocha-Singh, M.D., Prairie Vascular Institute, Springfield, Ill., explains advancements in device therapy for hypertension at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 annual meeting. 
 

References:

1. Kearney PM, et al. “Global burden of hypertension: Analysis of worldwide data.” Lancet. 2005;365(9455):217-23.

2. Pierdomenico SD, Lapenna D, Bucci A, et al. Cardiovascular outcome in treated hypertensive patients with responder, masked, false resistant, and true resistant hypertension. Am J Hypertens. 2005;18: 1422–8.

 

Related Content

Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Cook Medical Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments
News | Cath Lab | March 20, 2019
March 20, 2019 — Cook Medical is recalling one lot of its...
Overlay Init