iVascular’s Neurothrombectomy Devices Evaluated in S3MTIC Study

July 20, 2023—iVascular announced that the S3MTIC study is being conducted with the primary objective of determining the safety and efficacy of treating large vessel occlusions with the company’s three neurothrombectomy devices: the iNedit balloon distal access catheter, the iNdeep microcatheter, and the iNtercept stent retriever.

The S3MTIC study will enroll a total of 225 patients across 20 sites in four countries: Spain (14 sites), Belgium (one site), Germany (three sites), and France (two sites). The company advised that study enrollment has surpassed 50% of its planned goal.

Juan Macho, MD, the S3MTIC study’s Principal Coordinating Investigator, and Coinvestigator San Román MD, from Hospital Clínic of Barcelona, Spain, commented in iVascular’s press release, “The recruitment is going well so far. To date, 115 patients have been recruited, all of them from centers across Spain. The first results will be reported by the beginning of 2024.”

The Hospital Clinic de Barcelona, Hospital de Bellvitge in Barcelona, Hospital de la Vall d’Hebron in Barcelona, Hospital Central de Asturias in Oviedo, and Hospital Reina Sofía in Cordoba are the centers that have enrolled the most patients.

According to the company, the iNedit balloon distal access catheter combines access with distal flow arrest with a distensible balloon located 5 cm from the tip of the catheter. It is intended for mechanical thrombectomies.

The iNdeep microcatheter is a single-lumen catheter from proximal to distal shaft used to access the small and tortuous vasculature through a guidewire.

The iNtercept retriever thrombus extractor device is designed to restore blood flow in patients with ischemic stroke caused by intracranial vessel occlusion, stated iVascular.