PAD: Boston Scientific wins FDA, CE Mark nods for thrombectomy catheter

Boston Scientific (NYSE:BSX) said yesterday it won both FDA premarket approval and CE Mark approval in the European Union for its AngioJet ZeltanteDVT thrombectomy catheter designed to treat deep vein thrombosis.

The ZelanteDVT is the 1st AngioJet catheter from Marlborough, Mass.-based Boston Scientific specifically designed to treat deep vein thrombosis, specifically in large-diameter upper and lower limb peripheral veins, the company 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,”  Mitchell Silver of Columbus, Ohio’s Riverside Hospital said in a press release.

The company said the device offers “4 times the thrombus removal power of current market-leading AngioJet catheters,” and is designed to remove large venous clot burdens to restore blood flow.

“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,” peripheral interventions prez Jeff Mirviss said in prepared remarks.

Last month, Boston Scientific recalled nearly 1,000 components used with its Rotablator atherectomy device after receiving 3 reports that the catheter’s guidewire fractured during procedures to remove plaque from the coronary arteries.

In 1 case, the patient died 4 days after the wire fractured and the device’s rotating burr, moving at 195,000 to 200,000 rpm, pierced the artery wall, according to the FDA’s adverse events database.

In an Oct. 8 letter to customers, Boston Scientific recalled 955 of the RotaWire Elite and WireClip torquer components.

 

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