Boston Scientific's AngioJet ZelanteDVT Receives FDA and CE Mark Approvals

November 30, 2015—Boston Scientific Corporation announced it has received US Food and Drug Administration and European CE Mark approval for the AngioJet ZelanteDVT thrombectomy catheter to treat deep vein thrombosis (DVT) in large-diameter upper and lower limb peripheral veins. The ZelanteDVT catheter is the first AngioJet catheter designed specifically to treat DVT, stated the company.

The ZelanteDVT catheter provides four times the thrombus removal power of current market-leading AngioJet catheters. The device was designed to efficiently remove large venous clot burdens and facilitate rapid restoration of blood flow, potentially decreasing procedural time, quickly relieving symptoms, and reducing late complications.

Boston Scientific stated that the ZelanteDVT thrombectomy set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including DVT, from iliofemoral and lower extremity veins ≥ 6.0 mm in diameter, and upper extremity peripheral veins ≥ 6.0 mm in diameter. It is also intended for use with the AngioJet Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Mitchell Silver, DO, of Riverside Hospital in Columbus, Ohio, commented in the press release, “There has been a clinical need for a stronger thrombectomy catheter to support treatment modalities in addressing challenging cases of deep vein thrombosis. The unique features of the ZelanteDVT catheter make it well-suited to treat a wide range of thrombotic occlusions, thus potentially decreasing bleeding risks and reducing patients' need for intensive care stays.”