InterVene Receives FDA 510(k) Clearance for Recana®, the First Fully Integrated Thrombectomy System for Venous In-Stent Restenosis and Native Vessel Obstructions

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REDWOOD CITY, Calif.--(BUSINESS WIRE)--Oct 31, 2025--

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.

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Recana is the first fully integrated platform designed for treating in-stent 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.

“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, M.D., Chief of Vascular and Interventional Radiology, Northwestern Medicine, Chicago, Illinois. “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.”

For the latest news and information on the Recana System, visit www.intervene-med.com and follow InterVene on LinkedIn.

About InterVene, Inc.

InterVene is a privately held medical technology company based in Redwood City, Calif., focused on developing transformative products to treat the long-term complications of venous disease. Its flagship technology, the Recana® Thrombectomy Catheter System, was designed to treat venous in-stent restenosis and native vein obstructions and occlusions. InterVene is backed by RiverVest Venture Partners and Treo Ventures. For more information, visit www.intervene-med.com and connect on LinkedIn.

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CONTACT: Media Contact:

John Giesen

Sr. Director, Marketing

InterVene, Inc.

[email protected]

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH FDA MEDICAL DEVICES SURGERY GENERAL HEALTH CARDIOLOGY BIOTECHNOLOGY

SOURCE: InterVene, Inc.

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PUB: 10/31/2025 08:30 AM/DISC: 10/31/2025 08:31 AM

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