Data Published in The Lancet Shows Positive Results at Primary Endpoint in the Treatment of Resistant Hypertension with MobiusHD Device
Sep 1, 2017
Publication Follows Positive Interim Results in US and EU Patients Presented at the European Society of Cardiology Conference
MOUNTAIN VIEW, Calif.– (September 1, 2017) –Vascular Dynamics, Inc. (VDI), a privately held medical device company developing novel solutions for the treatment of hypertension, today announced European results of the company's first-in-human trial of its MobiusHD® implant published in The Lancet. The publication reported an average reduction of 24-hour ambulatory systolic blood pressure of 21 mmHg from baseline in the 30 European patients 6 months after implantation. Moreover, the Study authors reported that implantation of the MobiusHD device was straightforward for experienced interventionists, with a 100 percent procedural success rate.
The Lancet publication, which was posted today online, noted that the CALM- FIM_EUR study was a first-in-human feasibility study in which 30 patients were enrolled at 6 European centers in the Netherlands (5) and Germany (1) between December 2013 and February 2016. All patients had resistant hypertension, defined as office systolic blood pressure above 160 mmHg, despite the use of three or more antihypertensives, including a diuretic. The MobiusHD devices were implanted unilaterally in the internal carotid artery. Mean office blood pressure was 184/109 mmHg at baseline and was reduced by 24/12 mm Hg at 6 months. Mean baseline 24-hr ambulatory blood pressure was 166/100 mmHg at baseline and was reduced by 21/12 mmHg at 6 months despite an observed reduction in hypertensive medication. The investigators reported 6 serious adverse events, all of which were reported to have resolved without sequelae.
"These published results of the CALM-FIM_EUR study demonstrate that the MobiusHD device may significantly reduce both office and ambulatory blood pressure among patients on three or more drugs who have been unable to control their hypertension," said Wilko Spiering, MD, internist-vascular medicine specialist, University Medical Center Utrecht, the Netherlands and President of the Dutch Hypertension Society, lead author of the study. "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 Lancet publication comes immediately following the presentation of interim results of the CALM-FIM trials (US and EU study data) at a podium session at the 2017 Annual Congress of the European Society of Cardiology in Barcelona by Dr. Spiering.
"These results present a potentially significant advance in the treatment of hypertension, particularly with regard to those patients whose blood pressure has remained uncontrolled despite lifestyle changes and multi-drug therapy," said Dr. Bryan Williams, co-Principal Investigator of the CALM 2 trial from University College London (UCL) Institute of Cardiovascular Science and National Institute for Health Research UCL Hospitals Biomedical Research Centre. He is also Chairman of the European Council on Hypertension of the European Society of Cardiology. "We hope that continued study in the upcoming CALM 2 trial will continue to garner the results we've seen thus far, which will provide an important addition to our approach to controlling this incredibly pernicious and deadly disease."
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 benefit of a minimally invasive therapy that can reduce ambulatory blood pressure significantly in these truly resistant patients, including those that have failed renal denervation, has always been our goal," said Robert Stern, president and CEO of Vascular Dynamics Inc. "With these positive results, we will now press on to gather the sham randomized controlled data to ensure that the MobiusHD can impact patient care positively."
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.
About Vascular Dynamics, Inc.
Vascular Dynamics develops catheter-delivered technologies to bring a better quality of life to patients who are resistant to conventional treatments for hypertension. The device is covered by ten issued and pending U.S. and international patents. The MobiusHD system has received a CE Mark for the treatment of hypertension in the European Union. However, the MobiusHD system is not commercially available in the United States. More information is available at www.vasculardynamics.com.
CAUTION: In the United States, the MobiusHD Device is limited by law to investigational use only.
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.
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