FDA OKs InterVene’s Recana Thrombectomy Catheter

InterVene, a company pioneering interventional devices for venous occlusions, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Recana thrombectomy catheter system to treat venous in-stent restenosis and native vessel obstructions.

The Recana system features a debulking catheter, introducer and collection sheaths, and nitinol collection baskets. The system was designed to simplify challenging venous procedures and improve clinical outcomes.

The company designed Recana to enable single-session treatment, reduce the need for additional devices, and boost procedural efficiency. Its stainless-steel helical coring element has a sharpened beveled edge to clear 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.

“Venous in-stent restenosis and residual native vessel obstructions can lead to long-lasting, debilitating complications for many patients and remain difficult to treat,” said Jeff Elkins, CEO of InterVene. “With the launch of the Recana System, we’re introducing a next-generation technology designed to address this critical need and significantly improve patient outcomes.”

“The long-term consequences of venous obstructions and occlusions can be devastating for patients,” added William Marston, MD, 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.”

The company announced it closed a $13 million Series A financing round co-led by new investor Treo Ventures and existing supporter RiverVest Venture Partners in October 2024.