InterVene’s Recana, a mechanical thrombectomy catheter designed to address venous in-stent restenosis (ISR) and clear vessel obstructions, has received 510(k) clearance from the US Food and Drug Administration (FDA).
ISR, or the re-narrowing of a blood vessel, is most commonly seen in deep venous stent placement, particularly in patients with thrombotic pathology.
According to California-based InterVene, Recana is the first fully integrated platform for treating in-stent and native vessel obstructions. It contains a debulking catheter, introducer and collection sheaths, and nitinol collection baskets.
Recana primarily addresses thickened blood vessel walls (neointimal dysplasia) in stents to restore blood flow without damaging the stent structure. As a fully integrated system, it reduces the need for additional devices, thereby improving procedural workflows and overall patient outcomes, according to InterVene.
Research indicates that ISR, which most commonly occurs in the coronary arteries within a segment of a previously implanted stent, affects one in four patients who undergo angioplasty. Over 70% of patients who have undergone iliofemoral venous stenting are thought to be affected by the condition.
InterVene’s CEO, Jeff Elkins, commented: “Venous ISR and residual native vessel obstructions can lead to long-lasting, debilitating complications for many patients and remain difficult to treat. 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.”
The administration of antiplatelet or anticoagulant agents is viewed as a potential preventative measure against ISR, although the efficacy of each therapy is a matter of ongoing debate, with the respective regimens’ efficacy variable depending on the stenting circumstances.
Currently, the standard of care (SoC) for ISR is balloon angioplasty as a first line treatment, with atherectomy and laser ablation being alternative treatment options in more persistent and complex cases.
Adequate vein preparation ahead of stent placement is viewed as an important measure to limit the risk of neointimal dysplasia, a key cause of ISR or restenosis in procedures without stenting.
Minnesota-based VentureMed recently raised $28m to accelerate the commercial adoption and expand indications for its FLEX Vessel Preparation (FLEX VP) system. FLEX VP is designed to optimise vessel preparation and access management ahead of peripheral arterial disease (PAD) and arteriovenous fistulas and graft (AVF/AVG) interventions, such as drug-coated balloon angioplasty and stent placement.
