Web14. apr 2024 · Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. ... CAT12 is a large-lumen aspiration catheter that ... WebObjective. The use of catheter-directed thrombolysis (CDT) may provide clinical benefit in patients with acute deep venous thrombosis (DVT), but significant doubt remains about its indications and risks. We assessed technical success in resolution of acute iliofemoral or central DVT after single-session treatment with a novel mechanical aspiration …
510(k) Premarket Notification - Food and Drug Administration
WebINDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate ... Web1. jún 2024 · Penumbra Indigo aspiration system is a suction embolectomy device that has the advantage of rapid thrombus removal without the increased bleeding risk associated with thrombolysis. [2] It consists of a flexible small-bore aspiration catheter (8F & 12F) connected to a continuous aspiration system that generates a continuous aspiration … shire mobility banbury
Penumbra Indigo® System Vascular Thrombectomy
Webperipheral mechanical thrombectomy with aspiration. 22. 510 (k) Number. K210083. Device Name. Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, … Web22. sep 2024 · Penumbra’s newest generation offering combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding … Web20. nov 2024 · The latest generation of Penumbra’s continuous aspiration thrombectomy system features Indigo System Lightning 12 which combines the new Indigo System CAT … shire mobility limited