InspireMD Announces FDA Approval of the CGuard® Prime TransCarotid Stent System for Transcarotid Artery Revascularization (TCAR) Procedures
Key Highlights
- ➤FDA approves CGuard Prime for TCAR procedures in the United States
- ➤CGUARDIANS II reported 100% acute device success across 50 pivotal patients
- ➤CGUARDIANS II reported zero deaths, strokes, myocardial infarctions, or stent thrombosis at 30 days
- ➤TCAR approval adds access to over 35,000 annual U.S. procedures
- ➤Approval doubles CGuard Prime’s total addressable market beyond CAS procedures
Expert Statements
Marvin Slosman, Chief Executive Officer of InspireMD
“Today’s approval is a major milestone for InspireMD and for the physicians and patients who may benefit from TCAR as a treatment option for carotid artery disease.”
Marvin Slosman, Chief Executive Officer of InspireMD
“This approval extends our CGuard implant to TCAR procedures and is expected to provide a strong near-term growth driver for InspireMD.”
Marvin Slosman, Chief Executive Officer of InspireMD
“We believe InspireMD is the first and only company to approach carotid revascularization and stroke prevention with both CAS and TCAR delivery options and an implant-first mission, and we view this TCAR approval as an incredibly important step in advancing our leadership in this field.”
Marvin Slosman, Chief Executive Officer of InspireMD
“We look forward to providing patients and physicians with this next-generation stent, which we believe delivers unmatched clinical results.”
Patrick J. Geraghty, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis and co-lead investigator of the CGUARDIANS II study
“TCAR has become an increasingly important technique for carotid revascularization in the U.S., and we believe the availability of CGuard Prime for TCAR gives physicians a differentiated stent option designed around sustained embolic protection.”
Patrick J. Geraghty, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis and co-lead investigator of the CGUARDIANS II study
“The ability to combine CGuard’s MicroNet technology with transcarotid access and existing flow-reversal neuroprotection provides physicians with an important new option for treating patients with carotid artery disease.”
- Approval doubles the CGuard Prime platform’s total addressable market in the U.S. with additional access to over 35,000 TCAR procedures annually –
- Approval supported by CGUARDIANS II pivotal trial data, which demonstrated 100% acute device success and zero death, stroke, myocardial infarction or stent thrombosis reported at 30 days -
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