InterVene recently announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Recana thrombectomy catheter system, which is designed for the treatment of venous in-stent restenosis and native vessel obstructions.
A press release notes that 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 (University of North Carolina, Chapel Hill, USA). “Based on my pre-clinical experience, I believe the Recana system represents a promising treatment option that overcomes key limitations of traditional recanalisation methods.”
InterVene shares that it 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 bevelled 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.
“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,” said Kush Desai (Northwestern Medicine, Chicago, USA). “This innovative solution has the potential to transform the standard of care for this challenging condition, ultimately improving patient outcomes and quality of life.”
