indigo system lightning 12

February 2022. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. More recently, a number of other endovascular mechanical thrombectomy devices have been introduced as treatment options; however, many physicians still rely on adjunctive tPA, either to lace the thrombus at time of procedure or postoperatively via an in-dwelling lytic catheter. However, it has also been associated with an unsatisfying revascularization rate due to the detection of residual thrombus in distal vessels. A 67-year-old woman with a history of venous thrombus and iliac venous stenting presented with significant recurrent left lower extremity venous thrombus, and the patients symptoms did not significantly improve with anticoagulation alone. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. The thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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 Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays. Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention, said Adam Elsesser, president and chief executive officer, Penumbra. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use open or damaged packages. Associate Professor of Radiology and Surgery If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Charlotte, North Carolina Image showing the total thrombus removed. Such results give more evidence for a shift of treatment recommendation toward endovascular options in the patients with ALI, as already suggested by the recent European Society of Cardiology/European Society for Vascular Surgery guidelines. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Precautions The device is intended or single use only. Otherwise, this could result in degradation of the performance of this equipment. The decision was made to proceed with mechanical thrombectomy. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Maintain a constant infusion of appropriate flush solution. Created with Sketch. Poor distal runoff from acute thrombus. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. 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. In PE cases, patients are often emergent and need interventions that provide immediate relief. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Semin Dial. Next Article Chief of Vascular Surgery Next Article Siena, Italy As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). 2023 Bryn Mawr Communications II, LLC. Penumbra's Indigo System With Lightning Intelligent Aspiration Penumbra Indigo System | Vascular Thrombectomy The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a right ventricular/left ventricular (RV/LV) ratio reduction of 27.3% at 48 hours. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. July 14, 2020P enumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the company's next-generation aspiration system for peripheral thrombectomy.. 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. . Lightning 12 combines the Indigo System CAT12 aspiration catheter with lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's unique clot detection mechanism. Do not block bottom air vents. The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. 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. University of Minnesota The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. Do not resterilize or reuse. Figure 2. Lightning is paired with CAT8 or CAT12. Disclosures: None. Do not resterilize or reuse. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. CT revealed bilateral ALI (Figure 1). Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Indigo System | Penumbra Inc The patients right leg was completely cold, insensate, and immobile from the thigh down. right-arrow The audiovisual cues from Lightning and the thrombus detection algorithm enabled us to navigate the lobar branches of the PA. Lightnings audio cues, in the form of clicking, help with clot detection to optimize thrombus removal and focus on the screen rather than monitor flow through the tubing and canister. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. In addition to Lightning 12, the Indigo System also now includes Lightning 8 which combines the Indigo System CAT 8 Aspiration Catheter with Lightning Intelligent Aspiration for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. 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. This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. Disclosures: None. 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). Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. Miami Vascular Specialists Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use.

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