InterVene’s Recana Thrombectomy System Cleared by FDA

November 6, 2025—InterVene, Inc. recently announced that it has received 510(k) clearance from the FDA for its Recana thrombectomy catheter system, which is designed specifically for venous in-stent restenosis and native vessel obstructions.

As noted in the press release, the Recana system integrates a debulking catheter, introducer and collection sheaths, and nitinol collection baskets to simplify complex venous interventions and improve procedural efficiency. InterVene said the system enables single-session treatment and may reduce the need for multiple devices during recanalization procedures.

According to the company, Recana’s stainless-steel helical coring element features a sharpened beveled edge to remove tough residual obstructions and occlusions, while a spiral nose cone aids vessel crossing. Nitinol collection baskets are deployed from the lower extremities to capture thrombotic debris, designed to streamline workflow and reduce embolic risk.

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

Kush Desai, MD, Chief of Vascular and Interventional Radiology at Northwestern Medicine in Chicago, continued, “The Recana system marks an important advancement in the treatment of venous stent obstruction, a common outcome following deep venous stent placement, particularly in patients with thrombotic pathology. This innovative solution has the potential to transform the standard of care for this challenging condition, ultimately improving patient outcomes and quality of life.”

InterVene previously announced the Recana’s first-in-human procedure in July of 2025.