Cardiovascular Systems announces 510k submission of Innova’s thrombectomy system

Cardiovascular Systems announced that Innova Vascular, Inc. has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration for its thrombectomy devices intended to treat peripheral vascular disease. Thrombectomy is a rapidly growing interventional procedure performed to remove blood clots from arteries and veins. CSI intends to acquire and commercialize each of the novel thrombectomy devices from Innova targeting peripheral vascular disease. Commercialization of the thrombectomy devices will be highly complementary to CSI’s broader portfolio of advanced technologies used in the treatment of cardiovascular disease. Sanjay Shrivastava, Ph.D., 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."