Data Published in The Lancet Shows Positive Results at Primary Endpoint in the Treatment of Resistant Hypertension with MobiusHD Device - Seite 2

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.