InspireMD's MicroNet embolic protection mesh on stents is designed to prevent emboli during carotid stenting.
February 9, 2021 — InspireMD Inc., developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced the appointment of Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee as the principal investigator for its planned U.S. FDA registration trial for CGuard EPS.
This upcoming trial will investigate the safety and efficacy of InspireMD's MicroNet embolic protection system technology for carotid stenting. It is designed to prevent stroke during stent placement and help improve long-term outcomes.
“Following a close review of the extensive European experience and clinical outcomes, I’m looking forward to participating in the upcoming U.S. pivotal trial for CGuard. There remains a significant need to address stroke prevention in the United States and based on CGuard’s protective MicroNet technology, I’m intrigued with the potential for success here,” Metzger said.
“InspireMD is extremely fortunate to have Chris Metzger enthusiastically agree to shepherd the CGuard clinical trial. 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," said Gary Roubin, M.D., Ph.D., InspireMD Director and internationally renowned interventional cardiologist recognized for his pioneering work in carotid stenting and embolic and protection devices.
Metzger currently serves as medical director of the Interventional and Diagnostic Catheterization Labs at Holston Valley Medical Center and medical director of clinical research at Ballard Health Systems, both located in Eastern Tennessee and Southwestern Virginia. Metzger is widely published and has participated in more than 100 clinical studies, in most of which he served as principal investigator.
“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. 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,” added Marvin Slosman, CEO of InspireMD.
The CGuard Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke. CGuard’s unique MicroNet technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional and next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure. InspireMD’s CGuard has created a new dimension in the protected treatment of carotid artery disease and has the potential to establish a new standard of care for the management of carotid artery disease and stroke prevention.
For more information: www.inspiremd.com