IRVINE, CA — Innova Vascular, Inc., a medical technology company developing innovative endovascular solutions for the treatment of vascular thromboembolism, today announced the completion of patient enrollment in the TRUST pivotal Investigational Device Exemption (IDE) clinical study evaluating the safety and effectiveness of the Laguna® Thrombectomy System for the treatment of pulmonary embolism (PE).
The TRUST study enrolled 107 patients across 17 clinical sites and evaluated the Laguna Thrombectomy System, an endovascular platform that combines aspiration and mechanical clot-retrieval technologies. The system is comprised of the Malibu® Aspiration Catheter System and the Laguna Clot Retriever® System.
The Malibu Aspiration Catheter System offers physicians a range of intermediate- and large-bore aspiration catheter options, including 12Fr, 16Fr, 20Fr, and 24Fr outer diameters. The Laguna Clot Retriever System is designed to mechanically delaminate, engage, and retrieve thrombus and may be used, at the physician’s discretion, in conjunction with the Malibu Aspiration Catheter System.