InspireMD has received a DEKRA medical device certification for the manufacture and commercialisation of its CGuard delivery catheter.
According to a press release, the catheter incorporates some design enhancements and a lower cost manufacturing structure. 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).
Alan Milinazzo, CEO of InspireMD comments, “We are pleased to receive DEKRA certification for our enhanced CGuard delivery catheter. Our CGuard 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 CGuard 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 CGuard. In addition, the all-comer single centre PARADIGM trial continue to show favourable angiographic and clinical outcomes in using the CGuard system in treating patients with carotid artery disease. PARADIGM is an investigator-initiated prospective evaluation of all-comer percutaneous carotid revascularisation in symptomatic and increased-risk asymptomatic carotid artery stenosis using CGuard Mesh-covered embolic prevention stent system.