News | Embolic Protection Devices | February 09, 2021

CGuard Carotid Embolic Protection Device Trial Will be Led by Chris Metzger

InspireMD's MicroNet embolic protection mesh on stents is designed to prevent emboli during carotid stenting.

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

Related Content

News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
News | Cath Lab

November 10, 2021 — Shockwave Medical a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely ...

Home November 10, 2021
Home
News | Cath Lab

November 10, 2021 — Philips Healthcare announced North American availability of new innovations in its portfolio of ...

Home November 10, 2021
Home
Subscribe Now