Ballad Health is leading a new clinical trial in the United States for a potentially groundbreaking new carotid stent. Holston Valley Medical Center in Kingsport served as the host facility for the very first case.
Chris Metzger, MD, Ballad Health’s chair of clinical research and medical director of the interventional and diagnostic catheterization labs at Holston Valley, performed six cases of the CGuard Embolic Protection System (EPS) last Thursday, marking the first time the leading-edge carotid artery stent has been used in this country. The CGuard system, developed and manufactured by InspireMD, is a novel mesh carotid stent designed to prevent strokes caused by carotid artery disease.
“Ballad Health is committed to advancing medical science that has the potential to improve the human condition,” said Ballad Health Chairman and Chief Executive Officer Alan Levine. “Through our clinical research team – headed by Dr. Metzger – we can enrich our communities by offering unique, groundbreaking treatment options that often aren’t available at most hospitals and health systems.
“The Appalachian Highlands is leading the United States in bringing what could be the next big breakthrough in stroke prevention. The CGuard system has the potential to significantly improve care and outcomes for patients all over the world, and it’s happening here first – all because of the reputation and expertise of Dr. Metzger and his team.”
In February, Dr. Metzger, who is a part of the Ballad Health CVA Heart Institute, was announced as the lead investigator for the planned federal Food and Drug Administration (FDA) registration trial for CGuard EPS. The announcement was made after InspireMDcompleted several international trials of the CGuard system, all of which demonstrated its effectiveness in the prevention of embolism-related strokes.
CGuard is designed with a unique MicroNet mesh that prevents plaque protrusion in the carotid artery – a narrowing of the brain artery known as carotid artery stenosis, which is thought to cause up to 20% of ischemic strokes. In the earlier international trials of CGuard, InspireMD reported sustained stroke protection in patients with symptomatic or increased-risk asymptomatic carotid stenosis over a 60-month period.
“There remains a significant need to address stroke prevention throughout the United States, including here in the Appalachian Highlands, where we have a higher-than-average incidence of many cardiovascular diseases,” Dr. Metzger said. “I followed the European experience and clinical outcomes of CGuard very closely, and I’m intrigued by its potential for success.
“We lose patients to strokes every year, and even some patients who survive never fully recover. Can the CGuard system prevent and save some of those in the future? We believe it can, the early international trials show it can, and we’re going to study it for full FDA approval.”
Dr. Metzger’s expertise is in such high demand for medical conferences a camera was installed in his cath lab to accommodate his regular demonstrations for national and international medical conferences such as VIVA New Cardiovascular Horizons, International Symposium of Endovascular Therapy, AMP and Transcatheter Cardiovascular Therapeutics (TCT) and Interventional Advances.
Similarly, for the initial July 22 CGuard cases, Ballad Health obtained informed consent from patients to allow livestreaming of the first procedures, so other team members, community leaders and members of the public could observe the work being done in Holston Valley’s cath lab.
“For our team, this is a very exciting day, and we see so much opportunity ahead,” Dr. Metzger said. “But for our patients, signing up for a clinical trial like this requires a great deal of bravery and trust in our team. Undergoing a cardiac procedure is never an easy thing, and the patients who are volunteering for this clinical trial – many of whom are our community members and neighbors – are playing a role in changing lives for people in the United States.”
