Vascular Dynamics’ MobiusHD™ System Receives CE Mark for the Treatment of Resistant Hypertension
System offers novel approach for controlling hypertension using the body’s natural hypertension control mechanism
MOUNTAIN VIEW, Calif., Vascular Dynamics, Inc., a private medical device company developing novel solutions for the treatment of hypertension, today announced receipt of CE Mark approval for its MobiusHD™ System, a minimally invasive system for the treatment of resistant hypertension. Approximately one in 10 people with high blood pressure, or nearly 100 million people worldwide, have drug-resistant hypertension.
“Receiving CE Mark approval for the treatment of resistant hypertension is a major milestone for our company as we validate our novel solution for the millions of people whose hypertension is not adequately controlled by drugs,” said Robert Stern, President and CEO of Vascular Dynamics. “Initial results suggest significant improvement in the average blood pressure readings post barostenting procedure in our ongoing CALM first-in-human clinical trials in the U.S. and EU and we are progressing toward the filing of our International Pivotal study to support our U.S. FDA approval.”
Drug-resistant hypertension is a major unmet medical need as it significantly increases the risk of heart disease, stroke and kidney disease. The MobiusHD 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 amplify the body’s natural response to lower blood pressure through vasodilation.
“Options for patients to reduce their blood pressure are limited once they have failed multi-drug therapy. We have seen very good results in the patients we have treated at our center in the first-in-human clinical trial with the MobiusHD barostenting procedure. We are very excited about the new MobiusHD barostenting procedure and look forward to being able to provide it to our patients who have limited treatment options,” said Wilko Spiering, MD, UMC Utrecht, President of the Dutch Society of Vascular Internists and Secretary of the Dutch Society of Hypertension. “Our team looks forward to working with the Vascular Dynamics team to accelerate the clinical process with the next round of studies in the EU.”
“I’ve seen numerous approaches to controlling resistant hypertension over the years,” said Gregg W. Stone, MD, Director of Cardiovascular Research and Education at Columbia University Medical Center/New York Presbyterian Hospital and co-chair of the upcoming Vascular Dynamics’ MobiusHD International pivotal study. “Most drugs have side effects leading to poor compliance, and more invasive approaches have other drawbacks.
“The MobiusHD is a simple, passive implant that is designed to reduce blood pressure while preserving the body’s natural ability to modulate blood pressure. The minimally invasive MobiusHD barostenting procedure could be life changing for this patient population while also reducing the cost of healthcare,” added Dr. Stone.
“We now have eight active centers in the U.S. and 13 centers in the EU open for recruitment. We are taking a measured approach with our clinical trials to ensure that we are gathering the appropriate data and maintaining our safety profile,” added Mr. Stern. “We have the advantage of insight from a veteran team of medical device professionals and are well funded, having raised about $30 million from ‘blue chip’ investors including Invus Opportunities, HBM Healthcare Investments, Rainbow Medical and the MedFocus Funds.”
Source: Vascular Dynamics, Inc.