CSI Announces FDA 510(k) Submission of Innova Vascular Thrombectomy System

January 4, 2023—Cardiovascular Systems, Inc. (CSI) announced that Innova Vascular, Inc. has submitted a 510(k) premarket notification to the FDA for its thrombectomy devices intended to treat peripheral vascular disease.

CSI intends to acquire and commercialize each of the thrombectomy devices from Innova that target peripheral vascular disease. The company stated that commercialization of the thrombectomy devices will be complementary to CSI’s broader portfolio of technologies used in the treatment of cardiovascular disease.

CSI advised that pending regulatory clearance in the United States and completion of the acquisition of the first Innova system, the company could begin to commercialize a portfolio of aspiration catheters and clot retrieval devices for use in peripheral vasculature in approximately 6 months.

The portfolio and corresponding indications for use will be expanded to include the treatment of deep vein thrombosis and pulmonary embolism after completion of the respective clinical trials and subsequent 510(k) clearances. These trials are expected to begin enrolling later in 2023, stated the company.

Under the terms of the agreements signed with Innova, CSI has provided financing to Innova for the development of the thrombectomy devices. Under an acquisition option agreement, upon Innova’s completion of key technical, regulatory, and clinical milestones in the development program, CSI will have exclusive rights to acquire the thrombectomy devices, subject to the satisfaction of closing conditions set forth in the agreement.