Vascular Dynamics said today it won CE Mark approval for its MobiusHD minimally invasive hypertension treatment device.
The MobiusHD is a passive implant delivered percutaneously designed to amplify signaling measured by the baroreceptors in the wall of the carotid sinus. The device reduces blood pressure due to the increase in baroreceptor signaling.
“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. 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,” CEO Robert Stern said in a press release.
The device is specifically designed to treat patients with drug-resistant hypertension, something Vascular Dynamics says is a major unmet medical need as it significantly increases the risk of heart disease, stroke and kidney disease.
“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. 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,” Dr. Wilko Spiering of the Dutch Society of Vascular Internists said in prepared remarks.
The MobiusHD is designed to work with the body’s natural ability to lower blood pressure through vasodilation, the Mountain View, Calif.-based company said.
“I’ve seen numerous approaches to controlling resistant hypertension over the years. 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,” Dr. Gregg Stone of the Columbia University Medical Center said in a prepared statement.
“We now have 8 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. 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,” Stern said.