Pioneering Medical Innovations
The FDA granted premarket approval for the Embrace Hydrogel Embolic System for embolization of hypervascular tumors in peripheral arteries of 5 mm or less — the first liquid embolic approved for this indication supported by a prospective, randomized, controlled trial.
The FDA granted 510(k) clearance for the Zoom 7X Catheter, the first catheter featuring CenTRX Technology for enhanced navigation and asymmetric clot ingestion, with first patient cases completed.
A late-breaking abstract at the SNIS 2025 annual meeting reported strong reperfusion and safety results with the Zoom System in stroke patients with M2 vessel occlusions.
Enrollment was completed in the SYMPHONY-PE IDE study evaluating the Symphony Thrombectomy System for acute pulmonary embolism.
The company will fund an investigator-initiated randomized trial comparing continuous dual aspiration thrombectomy with the Zoom Stroke System plus best medical treatment versus best medical treatment alone for M2 occlusions.
Instylla submitted the final module of its premarket approval application for the Embrace Hydrogel Embolic System, including clinical study results supporting the hypervascular tumor embolization indication.
Instylla announced FDA 510(k) clearance of the Tembo Embolic System, expanding its portfolio of solutions for peripheral vascular embolization.
The FDA granted 510(k) clearance for the Zoom System, the first comprehensive stroke thrombectomy system to include large-bore .088-inch catheters indicated for both access and aspiration, supported by final Imperative Trial data.
Imperative Care shared results from its pivotal Imperative Trial of the Zoom Reperfusion System in ischemic stroke, presented in connection with the SNIS annual meeting.
151 subjects enrolled in various stages of loading and randomization in SOL-1 pivotal study of AXPAXLI in wet AMD as