News | Hypertension | August 30, 2017

MobiusHD Device Shows Promise in Treatment of Resistant Hypertension

Interim data presented at European Society of Cardiology (ESC) conference showed blood pressure drop in 88 percent of patient cohort at six months

MobiusHD Device Shows Promise in Treatment of Resistant Hypertension

August 30, 2017 — Vascular Dynamics Inc. announced interim results of the company’s first-in-human trial of its MobiusHD implant presented in a podium presentation at the European Society of Cardiology (ESC) in Barcelona. The data showed an average reduction of ambulatory systolic blood pressure of 20 mmHg from baseline in the first 40 patients (of an anticipated 50) to reach the six-month endpoint in studies conducted in the U.S. and E.U.

These interim results of the CALM-FIM (Controlling and Lowering Blood Pressure with MobiusHD First in Man) trial provided results from the first cohort of 40 patients evaluated in the United States and Europe. The data demonstrated that at the six-month evaluation point, 88 percent of the 40-patient cohort had a greater than 10 mmHg drop in office systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure. Many of these patients also experienced a reduction in their use of antihypertensive medication. 

"These interim data show significant promise in treating patients with resistant hypertension — that is, those who remain uncontrolled even after as many as three or more antihypertensive drugs,” said Wilko Spiering, M.D., internist-vascular medicine specialist, University Medical Center Utrecht, the Netherlands and president of the Dutch Hypertension Society, who presented the CALM-FIM data as one of the trial investigators. “Our positive experience with the MobiusHD device demonstrates the need for continued investigation in a sham-controlled setting, which is currently running in the Netherlands and is starting up in the United States, United Kingdom and Germany shortly.”

The interim results presented at the ESC conference will be followed by a study to be published in The Lancet on Sept. 1, 2017, which outlines the final results of the CALM-FIM_EU study.

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.

In the United States, the MobiusHD Device is limited by law to investigational use only. Read the article "Vascular Dynamics to Initiate U.S. Trial for MobiusHD System for Resistant Hypertension."

Hypertension, or elevated blood pressure, is a common medical condition that currently affects 1 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.

Patients experiencing resistant hypertension are uncontrolled with at least three antihypertensive drugs and 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

 

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