InterVene has announced the successful completion of 30 cases using the Recana thrombectomy catheter system. The cases were performed across the company’s limited US market release and its European first-in-human study.
A press release notes that Recana is the first fully integrated mechanical thrombectomy system to receive US Food and Drug Administration (FDA) 510(k) clearance for the treatment of venous in-stent restenosis (ISR) and residual venous obstructions in native veins. The system features a stainless steel, helical debulking catheter, material collection baskets, and introducer and collection sheaths, designed to simplify complex venous procedures and improve clinical outcomes.
“In-stent restenosis is a common complication following venous stenting,” said Stephen Black (Guy’s and Thomas’ Hospital, London, UK). “Many of these patients experience debilitating symptoms, but treatment is often limited to conservative care. My experience with Recana has fundamentally changed how I approach this disease.”
InterVene is currently conducting a limited US commercial release with select physicians specialising in ISR and residual venous obstructions. The company is also sponsoring prospective clinical studies in Galway, Ireland, led by Gerry O’Sullivan, and London, UK, led by Stephen Black.
The first 30 cases included patients having both ISR and native vessel obstructions, many of whom had experienced years of symptoms and multiple prior treatment attempts. InterVene plans to continue its limited market release as it prepares for a broader commercial launch later this year.
