InspireMD's CGuard EPS Evaluated in IRON-GUARD Italian Registry
May 24, 2017—InspireMD, Inc. recently announced the publication of 30-day results from the investigator-initiated IRON-GUARD Italian clinical registry by Francesco Speziale, MD, et al in EuroIntervention. IRON-GUARD was an independent, multicenter, multidisciplinary clinical study on treating patients with carotid artery disease using the company's CGuard embolic prevention system (EPS) at 12 Italian centers.
According to the company, the IRON-GUARD registry enrolled 200 patients and showed results of 100% technical success in placing the device and no incidence of major adverse cardiovascular events (death, major stroke, or myocardial infarction) in all patients at 30 days. The investigators observed five (2.5%) minor strokes and two (1%) transient ischemic attacks, which were resolved by 30 days.
In InspireMD's press release, Dr. Speziale commented, “In our multicenter, multispecialty experience, use of the CGuard EPS in routine clinical practice was associated with no major periprocedural neurologic complications and a total elimination of postprocedural neurologic complications after 30 days. The CGuard EPS has shown itself to be a promising treatment for carotid lesions.”
The CGuard EPS has gained European CE Mark approval. In September 2015, the company announced the commercial launch of the device in Europe through its distribution partner, Penumbra, Inc. It is not approved for sale in the United States.
In related news, the company announced that a team led by Prof. Alberto Cremonesi, MD, performed a live endovascular interventional procedure featuring the CGuard EPS at the EuroPCR 2017 conference, which was held May 16–19 in Paris, France.
Prof. Cremonesi serves as one of the Course Directors of EuroPCR. He is Chief of the Cardiovascular Department and Director of the Interventional Cardiovascular Unit of Maria Cecilia Hospital–GVM Care & Research, in Cotignola, Italy.
In the company's announcement, Prof. Cremonesi commented, “The CGuard EPS carotid stent performance was excellent and lived up to our expectations. It will be an important tool in the treatment paradigm for carotid artery disease as the carotid artery stenting procedure becomes an increasingly viable alternative to carotid artery endarterectomy/surgery in Europe.”