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Ballad Health hosts first United States clinical trials of CGuard Embolic Protection System

Friday, July 23, 2021

Ballad Health hosts first United States clinical trials of CGuard Embolic Protection System

Ballad Health CVA Heart Institute cardiologist Dr. Chris Metzger leads national study to gauge stent’s effectiveness as stroke prevention tool

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, Tennessee, 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) on Thursday, July 22, 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 InspireMD completed several international trials of the CGuard system, all of which demonstrated its effectiveness in the prevention of embolism-related strokes.

“The appointment of Chris Metzger as our principal investigator is an important step toward the initiation of our pivotal clinical trial for CGuard in the United States,” said Marvin Slosman, CEO of InspireMD, at the time of Dr. Metzger’s appointment. “We are confident that connecting the study to such a well-respected and experienced practitioner will help guide the continued development and execution of the study to a successful conclusion, reflective of the results we have seen internationally. We are grateful to Dr. Metzger for his collaboration and look forward to providing updates on the trial’s development.”

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.”

The CGuard system represents the potential to establish a new standard of care for the management of carotid artery disease and stroke prevention, and the first clinical trial cases are drawing significant attention from international cardiovascular leaders. In fact, Dr. Gary Roubin, an internationally renowned interventional cardiologist recognized for his extraordinary leadership in the field of cardiovascular intervention who also performed the groundbreaking work in the development of the first FDA-approved coronary stent, Gianturco-Roubin Flex Stent, came to Holston Valley to observe Dr. Metzger as he performed the CGuard cases.

Dr. Roubin – who trained and mentored Dr. Metzger earlier in his career – was an enthusiastic supporter of his protegee serving as the principal investigator for the CGuard system’s FDA trials, saying, “Chris is an extremely skilled, high-volume cardiovascular and carotid stent operator. He is also a highly regarded mentor and educator. His vast clinical trial experience will bring strong leadership to this landmark FDA study.”

Under Dr. Metzger’s leadership, the cardiovascular program at Holston Valley has performed as the No. 1 or No. 2 enroller in the United States and globally in at least 30 top research trials, and it is now leading trials for CGuard.

Additionally, Dr. Metzger and his colleagues at Holston Valley have led the hospital to earn recognition through dozens of accolades and honors in the past decade. Despite facing a global pandemic, Holston Valley earned several recognitions in 2020, including a nod from the American Heart Association through the Mission: Lifeline® Gold Receiving Quality Achievement Award for eight consecutive years.

“Even before these trials, our cardiac catheterization lab has marked several major achievements in healthcare, including the region’s first transcatheter aortic valve replacement, the nation’s top-ranked carotid artery stenting program, the only United States demonstration site for international conferences and quite a few leading clinical trials and studies,” said Lindy White, president of Holston Valley and CEO of Ballad Health’s Northwest Market. “Dr. Metzger and his team are contributing to the global conversation every day, and I never want to lose sight of how fortunate we are to have them at Holston Valley.

“The team at InspireMD is at the precipice of affecting thousands of lives that would have been irrevocably altered by strokes each year. And we’re honored that Holston Valley gets to be part of that story.”

Earlier this year, Holston Valley was also the only United States hospital selected as a demonstration site for the Leipzig Interventional Course, an interdisciplinary live course for physicians that connects colleagues from different specialties on a global stage to facilitate fresh discussion of vascular patients.

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.”

Dr. Metzger also contributes to medical education by hosting endovascular fellows from several of the nation’s top institutions – including Harvard Medical School, Massachusetts General Hospital and Cleveland Clinic – every year, so physicians can train at Holston Valley before completing their education. To date, Ballad Health has welcomed around 250 physicians to the Appalachian Highlands for cardiovascular training, and several have later elected to join the health system’s medical staffs to continue learning and growing their careers with Dr. Metzger.

“We have been pursuing a bold vision for the continued growth and development of an internationally-recognized cardiovascular program at Holston Valley, and the CGuard trials are a significant step forward in that,” said Julie Bennett, a member of the Ballad Health Board of Directors who also serves on the Kingsport Visioning Committee.

“These CGuard trials not only have major implications and benefits for our patients in Kingsport and the Appalachian Highlands, but for people all over the world — the work being done by the Holston Valley team today can someday benefit a patient who lives an ocean away. We’re very proud of our role in that, and we’re excited for what it means for the future.”

Information about the CGuard system is available at InspireMD.

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