Do not reuse. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. February 2022. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Lightning 12 with Intelligent Aspiration is a giant leap forward for the field of thrombectomy, and we have been very impressed with the early results at Sanger.. Venogram showing stents in the left CIV and EIV. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Catheters & Separators. Created with Sketch. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. After adjunctive endovascular (angioplasty, stenting, or lysis), TIMI 2-3 was reached in up to 95.3% of patients. Use prior to the Use By date. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 2023 Bryn Mawr Communications II, LLC. Poor flow through the left TPT. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. According to Penumbra, Lightning 12 combines the company's new Indigo System Cat 12 aspiration catheter with its Lightning Intelligent Aspiration to enable physicians to focus on optimizing thrombus removal using the systems clot detection mechanism. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. Bjrck M, Earnshaw JJ, Acosta S, et al. Penumbra Launches Indigo System Lightning 12 and Appoints Medical and Using the HTORQ angle on CAT12 to torque the catheter, several passes were made through the affected area, from the left popliteal to the external iliac vein (EIV) and internal iliac vein. The Next Generation of Thrombus Removal | Penumbra Inc (EXTRACT-PE). Poor distal runoff from acute thrombus. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Otherwise, this could result in degradation of the performance of this equipment. Risk Information. This combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology. New York, New York Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Preliminary data from the INDIAN registry is promising regarding early safety and efficacy for the revascularization of acute peripheral arterial occlusions with thromboaspiration as primary therapy. Contraindications Not for use in the coronaries or the neurovasculature. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. Figure 5. Otherwise, this could result in degradation of the performance of this equipment. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Contraindications There are no contraindications. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM No modification of this equipment is allowed. Contraindications Not for use in the coronaries or the neurovasculature. With contributions from Edoardo Pasqui, MD; Carlo Setacci, MD; and Giancarlo Palasciano, MD, Surgical management of lower extremity acute limb ischemia (ALI) has been considered the preferred treatment for years. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. MHealth Fairview System Medical Director for Interventional Radiology Operations The PRISM trial, a retrospective case analysis assessing the rate of TIMI 2-3 flow after the use of Indigo and specifically the XTRACT technique, showed an 87.2% rate of revascularization post-Indigo and subsequent treatment of underlying stenosis in the same setting.1 The newly completed study studying the same primary outcome as PRISM, the INDIAN registry, showed an even higher rate of revascularization, 88.7%.2 Sustained aspiration for ALI could potentially increase the revascularization rate by serving as an effective single-session frontline option.
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