InspireMD, a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today receipt of a DEKRA medical device certification for the manufacture and commercialization of its CGuardTM delivery catheter, which now incorporates some design enhancements and a lower cost manufacturing structure to support the scale-up of operations.
The certification also allows the Company to add-on facilities for seamless manufacturing work flow. DEKRA is a notified body for global certification of products, combining CE Marking with ISO 13485 Quality Management Systems in the testing of medical devices for sale in the European Union (EU).
The delivery catheter is commercialized in conjunction with the Company’s CGuard™ Embolic Prevention System (EPS).
Alan Milinazzo, CEO of InspireMD commented, "We are pleased to receive DEKRA certification for our enhanced CGuardTM delivery catheter, used when delivering the CGuardTM EPS into the carotid anatomy, supporting a more profitable and fluid scaling of our manufacturing operations.
"Our CGuardTM system continues to be well received during our initial product launch in key markets around Europe and our recent positive 12 month CARENET data should bolster our commercial efforts going forward."
Twelve month CGuardTM CARENET (CARotid Embolic protection Study using microNET) trial results demonstrated zero strokes or stroke-related deaths. Further, duplex ultrasound analysis confirmed no changes in the in-stent velocities between 6 and 12 months. This indicates no sign of vessel narrowing and is consistent with the durability of carotid artery treatment seen using CGuardTM.
In addition, the all-comer single center PARADIGM trial continue to show favorable angiographic and clinical outcomes in using the CGuardTM system in treating patients with carotid artery disease.
PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis using CGuard™ Mesh-covered embolic prevention stent system.
The proprietary CGuard™ Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary Embolic Protection Systems. The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.
MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate.
CGuard™ EPS is CE Marked and not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.