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September 30, 2014
InspireMD Commences Initial European Launch of CGuard EPS
October 1, 2014—InspireMD, Inc. announced that it has accelerated the limited market release of its CGuard carotid embolic protection system (EPS) after the recent positive data reported in the CARENET clinical trial. The company is launching the product with initial commercial sales to high-volume, key opinion leaders in carotid treatment, with a full European market release in the second quarter of 2015.
On September 16, the company announced that CARENET Principal Investigator Prof. Joachim Schofer, MD, presented the trial’s 30-day data at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. CARENET was a multispecialty trial that assessed the periprocedural safety and efficacy of CGuard systems in the treatment of carotid lesions.
According to InspireMD, the CGuard EPS uses the same MicroNet technology featured on the company’s MGuard and MGuard Prime coronary EPS. The MicroNet technology is a single-fiber knitted mesh wrapped on an open-cell stent platform that is designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods.
In March 2013, InspireMD announced that the CGuard EPS received European CE Mark approval. The device is not approved for sale in the United States.
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