FDA Approval And CE Mark for Boston Scientific’s DVT Catheter

Boston's newly approved DVT catheter

Boston Scientific has received U.S. FDA approval and CE Mark for the AngioJet™ ZelanteDVT™ thrombectomy catheter to treat deep vein thrombosis (DVT) in large-diameter upper and lower limb peripheral veins.


A challenging condition that may affect up to 2.5 million people in the U.S. and Europe annually, DVT occurs when a thrombus forms in one or more of the deep veins. Those at the highest risk of developing DVT tend to be older, overweight and inactive. Common symptoms include swelling, pain, tenderness, warm skin and/or discoloration in the affected leg, leg fatigue as well as surface veins can become more visible. The most serious complication of DVT can occur if part of the clot breaks off and travels through the bloodstream to the lungs, resulting in a pulmonary embolism (PE) which can be fatal. Standard DVT treatments include medications such as blood thinners or interventional procedures to remove or break up a clot, place a filter to capture a clot, or other surgical approaches for clot removal.

The ZelanteDVT catheter is the first AngioJet catheter designed specifically to treat DVT, claiming four times the thrombus removal power of current market-leading AngioJet catheters. The ZelanteDVT catheter 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.

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 greater than or equal to 6.0 mm in diameter, and upper extremity peripheral veins greater than or equal to 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.

Physician comments

“There has been a clinical need for a stronger thrombectomy catheter to support treatment modalities in addressing challenging cases of deep vein thrombosis,” said Mitchell Silver, DO, FACC, Riverside Hospital in Columbus, Ohio. “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.”

Company comments

“The new features of the ZelanteDVT catheter represent our focus on improving procedural efficiencies and reducing the economic burden associated with this challenging condition,” said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. “With this addition to our AngioJet portfolio, we are further evolving the current suite of life-changing therapeutic options available to physicians and their patients with deep vein thrombosis.”

Source: PR Newswire


Share your thoughts

Your email address will not be published. Required fields are marked *