Full Market Launch of InspireMD's CGuard Announced at CIRSE

September 28, 2015—InspireMD, Inc. announced the full market launch of the CGuard embolic prevention system for the treatment of carotid artery disease, which is available through its strategic distribution partner, Penumbra, Inc. The announcement was made at CIRSE 2015, the Cardiovascular and Interventional Radiological Society of Europe annual scientific meeting being held September 26–30 in Lisbon, Portugal.

The CGuard system has gained European CE Mark approval. It is not approved for sale in the United States. InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard), neurovascular, and peripheral artery procedures. 

Also at CIRSE 2015, Penumbra hosted a symposium led by Prof. Piotr Musialek, MD, who is Principle Investigator in the all-comer PARADIGM study that continues to document both the short-term and long-term benefits of using the MicroNet-covered CGuard technology in patients with carotid artery disease. The prospective PARADIGM study is evaluating the device in symptomatic and increased-risk asymptomatic patients with carotid artery stenosis.

At the EuroPCR 2015 meeting in May, Dr. Musialek presented data on 71 CGuard procedures in unselected all-comer patients in PARADIGM. He reported 100% stent system success and procedure success rates, periprocedural and 3-day complications of 0%, and no major adverse events periprocedurally or at 30 days by operator-independent neurologist and noninvasive cardiologist evaluation.