Healthcare company Penumbra has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its RED 62 Reperfusion Catheter.
The RED 62 is the new addition to the firm’s comprehensive Penumbra System, which is designed mainly for mechanical thrombectomy.
The catheter will help navigate complex distal vessel anatomy and provide strong aspiration, together with Penumbra ENGINE, to remove blood clots in acute ischemic stroke patients with large vessel occlusions.
The RED 62 Reperfusion Catheter is provided with a low diameter profile and extended length to reach the target vessel.
Penumbra has designed the catheter using the latest innovations in tracking and aspiration technology to address large vessel occlusions located in challenging distal vessel anatomy while enhancing powerful aspiration to remove blood clots.
Penumbra president and CEO Adam Elsesser said: “With the continued success of aspiration thrombectomy, physicians asked us to address navigation in more challenging distal vessels. RED 62 builds on our previous design generations, continuing our efforts to maximize both trackability and aspiration power.
“This is the first catheter in the RED series, which will provide physicians with the broadest portfolio of aspiration thrombectomy solutions for stroke management while also focusing on reducing overall healthcare costs.”
The Penumbra System consists of Reperfusion catheters, 3D Revascularization Device, the Penumbra ENGINE aspiration source and other accessories.
The system helps physicians to use aspiration, which serves as a minimally invasive vacuum inside the artery, to remove stroke-causing blood clots from the brain.
It is mainly used for the revascularisation of patients with acute ischemic stroke secondary to intracranial large vessel occlusions.
In November last year, Penumbra secured the expanded FDA approval for the new generation of its Indigo Aspiration System called Lightning 12.
Earlier this year, the company announced the commercial availability of Indigo System Lightning 7 in the US.
Lightning 7 is designed for single session arterial thrombus removal. It expands Penumbra’s offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy.
