REDWOOD CITY, Calif. — InterVene, Inc., a privately held medical device company developing innovative solutions for venous occlusions, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Recana Thrombectomy Catheter System. Recana is the first fully integrated platform specifically designed to treat venous in-stent restenosis and native vessel obstructions.
The Recana system combines a debulking catheter, introducer and collection sheaths, and nitinol collection baskets into a single, streamlined platform intended to simplify complex venous procedures and improve patient outcomes. By integrating multiple treatment functions, Recana allows physicians to perform single-session procedures, reducing the need for additional devices and improving overall efficiency.
“The long-term consequences of venous obstructions and occlusions can be devastating for patients,” said William Marston, M.D., Professor in the Department of Surgery at the 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.”
Recana’s stainless-steel helical coring element features a sharpened beveled edge designed to clear tough residual obstructions, while a spiral nose cone assists with lesion crossing. The system’s nitinol collection baskets capture thrombotic material from the lower extremities, helping streamline the workflow and ensure a clean vessel lumen.
“The Recana System marks an important advancement in the treatment of venous stent obstruction, a common complication following deep venous stent placement, particularly in patients with thrombotic pathology,” said Kush Desai, M.D., Chief of Vascular and Interventional Radiology at Northwestern Medicine in Chicago. “This innovative solution has the potential to transform the standard of care for this challenging condition, ultimately improving patient outcomes and quality of life.”
“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, Inc. “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.”
InterVene’s FDA clearance marks a major milestone in advancing treatment options for venous disease and reinforces the company’s mission to deliver innovative tools that enhance procedural precision and long-term patient care.
