The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Otherwise, this could result in degradation of the performance of this equipment. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. It will reduce the service life of the PENUMBRA ENGINE. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 2021 Nov 1;48(5):e217571. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Created with Sketch. . Do not use kinked or damaged devices. Otherwise, this could result in degradation of the performance of this equipment. 4. Penumbra also announced appointments for two newly created positions: Corey L. Teigen, MD, as Chief Scientific Officer and James F. Benenati, MD, as Chief Medical Officer. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Lightning is paired with CAT8 or CAT12. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. The goal of this study is to create a prospective multicenter study that provides safety and performance data on the Indigo System as a frontline percutaneous aspiration thrombectomy approach for ALI patients for whom immediate treatment and revascularization can maintain limb viability. This combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology. Atrium Health Do not resterilize or reuse. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. 1Virani, S.S. et al. Lightning Intelligent Aspiration. Figure 2. INDIGO SEPARATOR 4 is intended to be used with INDIGO CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Penumbra Announces U.S. Commercial Availability of INDIGO System A venogram was performed via left popliteal vein access, which demonstrated thrombosis of the left femoral vein (FV) and common femoral vein (CFV) (Figure 1) and the previously stented left common iliac vein (CIV) and external iliac vein (EIV) (Figure 2). Computer-Aided Thrombus Removal Using Penumbra's Lightning 7 and Rotational thrombectomy of acute peripheral vascular occlusions using the ThromCat XT device: techniques, indications, and initial results. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients. The results may not be predictive of all patients. Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. After adjunctive endovascular (angioplasty, stenting, or lysis), TIMI 2-3 was reached in up to 95.3% of patients. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Pulmonary embolism (PE) is a condition that occurs when blood clots, typically traveling from the veins in the legs, get caught in the arteries of the lungs. The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus. Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. Lightning 12: 12 F (4.04 mm) HTORQ (100 cm, 115 cm lengths) XTORQ (100 cm length) Lightning 7: 7 F (2.3 mm) XTORQ (130 cm length) CAT . Do not resterilize or reuse. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. To prevent fire or shock hazard, use a replacement power cord of equal rating. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. A wire test was conducted in the right leg to determine the composition of the clot. Enter your email address and we will contact you. Figure 2. 2. July 14, 2020Penumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the companys next-generation aspiration system for peripheral thrombectomy. Endovascular Today (ISSN 1551-1944 print and ISSN 2689-792X online) is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Thrombotic disease puts patients at high risk of . Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Cincinnati, Ohio rosen011@umn.edu Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510 (k) approval for the new generation of its Indigo Aspiration System, Lightning 12. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The patients right leg was completely cold, insensate, and immobile from the thigh down. Potential adverse . In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. If the cause cannot be determined, withdraw the device or system as a unit. If the cause cannot be determined, withdraw the device or system as a unit. Previous Article, Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE, With James Horowitz, MD, FACC; Mitchell J. (Photo: Business Wire). Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism . CT showed a bilateral PE with right heart strain. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. Rethinking Thrombus Removal With the Indigo System: Introducing Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Notably, Lightning 7 is designed . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Figure 3. Risk Information. There was poor distal runoff after wire crossing, indicating acute thrombus (, The Indigo System Catheter CAT8 was used in the superficial femoral artery (SFA) with several passes until flow was restored and the patient could move and feel his leg again (. Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. 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.
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