The Recana System is Designed for the Treatment of Venous In-Stent Restenosis and Native Vessel Obstructions
InterVene, Inc., a medical device company pioneering interventional devices for venous inflow and outflow obstructions, announced today that the first patient has been treated with its Recana Thrombectomy Catheter System for venous in-stent restenosis (ISR). The Recana System is the first fully integrated mechanical thrombectomy system designed specifically to address the long-term complications of venous disease, including ISR and native vein obstructions. The case was performed at University Hospital Galway in Galway, Ireland, by Dr. Gerry O'Sullivan, consultant interventional radiologist.
"The long-term sequelae of venous obstructions, whether in-stent or native vessel, are a devastating consequence of deep venous thrombotic disease. There remains a considerable gap in effective interventional treatments for physicians and their patients living with persistent symptoms related to venous outflow obstructions," said Dr. O'Sullivan. "I had previously tried and failed to recanalize this patient's vessels on four separate occasions Recana succeeded in just one. This technology offers real promise for patients with limited treatment options."
ISR is a common and challenging complication of venous stenting, typically managed with balloon angioplasty or stent relining both of which are suboptimal for restoring and maintaining long-term patency.1,2 Every year, millions of patients are affected by the long-term complications of deep venous obstructions, experiencing persistent symptoms such as leg pain, swelling, skin discoloration, and in the most severe cases, venous leg ulcers.3,4
The case was a result of successful collaboration between InterVene, Inc. and the University of Galway Institute of Clinical Trials. "We are proud to see Recana become one of the first innovations to enter clinical use in Ireland through the Hypercare initiative," said Fidelma Dunne, MD, PhD, director of the Institute for Clinical Trials at the University of Galway. "This first-in-human procedure reflects Hypercare's core mission to streamline the clinical trial process and accelerate patient access to breakthrough therapies."
"This successful first-in-human procedure comes after several years of rigorous work to prove a transformative design to address a major unmet need in venous disease," stated Jeff Elkins, CEO of InterVene. "We are proud to support Dr. O'Sullivan in caring for patients suffering from the life-limiting effects of ISR. Completing this first case marks an important milestone in bringing our technology to patients affected by the long-term complications of venous disease."
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. InterVene is backed by RiverVest Venture Partners and Treo Ventures. For more information visit www.intervene-med.com.
Caution: Investigational device. Limited by Federal (or United States) law to investigational use.
Caution: The Recana Thrombectomy Catheter System is an investigational device to be used exclusively for clinical investigations.
References
- Notten P, Ten Cate H, Ten Cate-Hoek AJ. Postinterventional antithrombotic management after venous stenting of the iliofemoral tract in acute and chronic thrombosis: A systematic review. J Thromb Haemost. 2021.
- Raju S, Davis M. Anomalous features of iliac vein stenosis that affect diagnosis and treatment. J Vasc Surg Venous Lymphat Disord. 2014.
- Engeseth M, Enden, T, Sandset, P.M. Predictors of long-term post-thrombotic syndrome following high proximal deep vein thrombosis: a cross-sectional study. Thrombosis J. 2021.
- Rabinovich A, Khan S. How I treat the possthrombotic syndrome. blood. 2018.
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Contacts:
info@intervene-med.com