Boston Scientific has secured US Food and Drug Administration (FDA) approval and CE Mark for its AngioJet ZelanteDVT thrombectomy catheter.
The catheter is designed for the treatment of deep vein thrombosis (DVT) in large diameter upper and lower limb peripheral veins.
Annually 2.5 million people in the US and Europe are affected by DVT, which occurs when a blood clot or thrombus forms in one or more of the deep veins, most frequently in the legs.
ZelanteDVT catheter was developed to effectively remove large venous clot burdens and facilitate rapid restoration of blood flow.
Riverside Hospital in Columbus Cardiovascular Disease doctor Mitchell Silver said: "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."
The company developed ZelanteDVT thrombectomy set to be used with the AngioJet Ultra Console to break apart and remove thrombus, including DVT, from iliofemoral and lower extremity veins greater than or equal to 6mm in diameter, and upper extremity peripheral veins greater than or equal to 6mm in diameter.
Boston Scientific peripheral interventions president Jeff Mirviss said: "The new features of the ZelanteDVT catheter represent our focus on improving procedural efficiencies and reducing the economic burden associated with this challenging condition.
"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."
The system can also be used with the AngioJet Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
In November, the company secured CE Mark for its next generation Watchman FLX left atrial appendage closure (LAAC) device.
The device is a catheter-delivered heart implant developed to close the LAA to avoid the migration of blood clots from the LAA, allowing the reduction of the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.
Image: AngioJet ZelanteDVT venous thrombectomy catheter. Photo: courtesy of Boston Scientific.