InterVene, Inc., a privately held medical device company pioneering interventional devices for venous occlusions, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Recana® Thrombectomy Catheter System for treating venous in-stent restenosis and native vessel obstructions.

Recana is a fully integrated system featuring a debulking catheter, introducer and collection sheaths, and nitinol collection baskets designed to simplify challenging venous procedures for physicians and improve clinical outcomes for their patients.

“The long-term consequences of venous obstructions and occlusions can be devastating for patients,” said William Marston, M.D., Professor, Department of Surgery, University of North Carolina, Chapel Hill. “Based on my pre-clinical experience, I believe the Recana System represents a promising treatment option that overcomes key limitations of traditional recanalization methods.”

InterVene designed Recana’s integrated system of complementary components to enable single-session treatment, reduce the need for additional devices, and improve procedural efficiency. Its stainless-steel helical coring element has a sharpened beveled edge to clear tough, residual venous obstructions and occlusions, with a spiral nose cone to assist with crossing. Nitinol collection baskets deploy from the lower extremities to capture thrombotic material, streamlining the procedure workflow.