Cardiovascular Systems announces US FDA 510(k) submission of Innova Vascular’s thrombectomy system

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Cardiovascular Systems, Inc.Cardiovascular Systems (CSI) announced that Innova Vascular (Innova) has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its thrombectomy devices intended to treat peripheral vascular disease.

CSI intends to acquire and commercialise each of the novel thrombectomy devices from Innova targeting peripheral vascular disease. Commercialisation of the thrombectomy devices will be complementary to CSI’s broader portfolio of advanced technologies used in the treatment of cardiovascular disease.

Sanjay Shrivastava, CEO of Innova, said, “the FDA submission of the thrombectomy devices for use in the peripheral vasculature marks an important milestone in our commitment to develop innovative technologies targeting large, underserved markets. We are excited to partner with CSI, which has been serving the interventional cardiology, interventional radiology, and vascular surgery communities that will be the primary users of this thrombectomy system.”

Pending regulatory clearance in the USA and completion of the acquisition of the first Innova system, CSI could begin to commercialise a portfolio of aspiration catheters and clot retrieval devices for use in peripheral vasculature in approximately six months. The portfolio and corresponding indications for use will be expanded to include the treatment of deep vein thrombosis and pulmonary embolism following completion of the respective clinical trials and subsequent 510(k) clearances. These trials are expected to begin enrolling later in 2023.

Scott R Ward, chairman, president and CEO of CSI said, “CSI’s strong commercial presence, with over 150 peripheral sales representatives, will make thrombectomy an excellent fit as we seek to reach more patients and drive increased revenue through our sales channel beginning later this year.”

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.


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