InspireMD
InspireMD is dedicated to helping prevent strokes and saving lives through innovative carotid intervention solutions. Headquartered in Miami, FL, the company focuses on transforming carotid artery intervention with advanced designs and data-driven products like the CGuard® Prime, a next-generation carotid stent with a dual-layer MicroNet™ mesh for enhanced stroke prevention. InspireMD aims to lead a global effort in stroke prevention, offering smarter, safer, and more effective treatment options.
Industries
Nr. of Employees
medium (51-250)
Products
Mesh-covered carotid stent system (commercially launched)
An implantable, dual-layer carotid stent system featuring a fine mesh covering intended to prevent plaque prolapse and reduce periprocedural and postprocedural cerebral embolism; approved for commercial use following regulatory review.
Mesh-covered carotid stent system (commercially launched)
An implantable, dual-layer carotid stent system featuring a fine mesh covering intended to prevent plaque prolapse and reduce periprocedural and postprocedural cerebral embolism; approved for commercial use following regulatory review.
Services
Clinical trial and registry support
Support for planning, site coordination, and execution of IDE trials, randomized controlled trials, and prospective registries including data collection and investigator engagement.
Regulatory and quality affairs support for device approvals
Preparation and submission of regulatory documentation to support market authorization under U.S. and European regulatory frameworks.
Clinical education and KOL webinar programs
Webinars, conference presentations, and educational videos featuring clinical experts and procedural demonstrations.
Distributor onboarding and commercial sales support
Registration and onboarding processes for distributors and sales channel enablement including ordering portals and partner tools.
Clinical trial and registry support
Support for planning, site coordination, and execution of IDE trials, randomized controlled trials, and prospective registries including data collection and investigator engagement.
Regulatory and quality affairs support for device approvals
Preparation and submission of regulatory documentation to support market authorization under U.S. and European regulatory frameworks.
Clinical education and KOL webinar programs
Webinars, conference presentations, and educational videos featuring clinical experts and procedural demonstrations.
Distributor onboarding and commercial sales support
Registration and onboarding processes for distributors and sales channel enablement including ordering portals and partner tools.
Expertise Areas
- Carotid stent design and development
- Clinical trial management and multicenter studies
- Regulatory submissions for implantable vascular devices (FDA PMA, CE MDR)
- Clinical evidence generation and medical publication
Key Technologies
- Mesh-covered stent technology
- Dual-layer stent architecture
- Embolic protection methods (flow reversal and distal protection)
- Intravascular ultrasound (IVUS)