Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. When 4 solid illuminated bars on the . Director of Interventional Radiology Investor Relations: Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbras most advanced clot removal technology for the treatment of pulmonary embolism. Do not resterilize or reuse. Localization of the thrombus was quite variable in our cohort of patients, although in the majority of cases (67%), patients presented with thrombus in the popliteal or BTK vessels. Dr. Benenati will join Penumbra on September 1, 2020, and will contribute to clinical and medical affairs strategies and advise upon global commercialization and market development activities. With a device time of only 5 minutes and no use of tPA, the patients symptoms were promptly relieved with no recurring episodes to date. Gianmarco de Donato, MD 1Virani, S.S. et al. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Otherwise, this could result in degradation of the performance of this equipment. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Disclosures: None. Mean PA pressure at the start of the case was 35 mm Hg. The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. Notably, Lightning 7 is designed . Figure 3. 1. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Poor flow through the left TPT. New York University Langone Medical Center Thomas S. Maldonado, MD Next Article Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Contraindications Not for use in the coronaries or the neurovasculature. 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. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. Do not use open or damaged packages. 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. Created with Sketch. 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. At discharge, there have been no adverse device events, and clinical success at 1 month (defined as the absence of death and limb loss) is 98.6%.4. Do not use kinked or damaged devices. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Semin Dial. INDIGO Aspiration System Indication for Use Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. Ballad Health System CVA Heart & Vascular Institute Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Do not resterilize or reuse. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The latest generation of Penumbras continuous aspiration thrombectomy system features Indigo System Lightning 12 which combines the new Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. Venogram showing stents in the left CIV and EIV. The INDIAN registry is a prospective, multicenter registry designed to investigate, in a controlled setting, the safety and initial efficacy of the Indigo System in the treatment of acute peripheral arterial thromboembolism. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. Miami, Florida rosen011@umn.edu CAT 12 is a . The Indigo System has been designed to address the limitations of traditional treatment options. Contraindications There are no known contraindications. Siena, Italy Do not resterilize or reuse. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Michael S. Rosenberg, MD, FSIR, FACR Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Created with Sketch. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. CT revealed that the patient had a bilateral PE with an elevated RV/LV ratio of 2.26, an elevated troponin level of 0.151 g/mL, and PA pressures at 35 mm Hg. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. Return all damaged devices and packaging to the manufacturer/ distributor. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use kinked or damaged devices. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. After considering the acute onset of symptoms and the history of thrombosis, we decided to proceed with the Indigo System to treat the bilateral PE in one session. STRIDE is currently ongoing. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Dr. Arko continued, "When dealing with thrombus, we have learned that it is the combination of the catheter along with powered aspiration that yields the most effective results. Disclosures: None. 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. Warnings/Precautions The canister is intended for single use only. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. I feel privileged to join Penumbras unparalleled group of talented engineers and leaders, and I look forward to contributing my scientific knowledge to help solve challenging medical problems., Dr. Benenati commented, Im excited to join Penumbra at this very important time for the company, where its poised for growth, as it moves into the next generation of intelligent clot removal and expand into rehabilitation with the recent launch of the Real system. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Indication For Use Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. Contraindications There are no contraindications. Use prior to the Use By date. Precautions The device is intended for single use only. Heart disease and stroke statistics2020 update: a report from the American Heart Association. right-arrow Program Director, Vascular Fellowship & Integrated Residency Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. (EXTRACT-PE). The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. All Rights Reserved Privacy Policy. betsy@merrymancommunications.com Manhattan Veterans Administration Hospital To prevent fire or shock hazard, use a replacement power cord of equal rating. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. To gain access into the lobar branches, a 5-F, 125-cm vertebral catheter over a 0.035-inch stiff, angled Glidewire (Terumo Interventional Systems) was used. Eric Moldestad, MD Figure 2. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. 12 F Laser Cut Hypotube Catheter. Figure 1. The Indigo CAT12 represents an advancement in mechanical thrombectomy given its ability to aspirate large-volume thrombus in a single-session setting, which is especially beneficial in larger-lumen vascular beds, such as large-caliber veins as demonstrated in this case. INDIGO Aspiration System Indication for Use Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's clot detection mechanism. Co-Director, Aortic Institute Figure 4. Figure 2. Do not use in an oxygen rich environment. University of Siena 2. Figure 2. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. COURSE OF TREATMENT. Postprocedural CT of the patients left pulmonary anatomy. After adjunctive endovascular (angioplasty, stenting, or lysis), TIMI 2-3 was reached in up to 95.3% of patients. Merryman Communications Precautions The device is intended for single use only. 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. PENUMBRA ENGINE Indication for Use Executive Vice Chairman To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Disclosures: Consultant to Penumbra, Inc. 2023 Bryn Mawr Communications II, LLC. Mean PA pressure postintervention was 21 mm Hg. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. CT showed a bilateral PE with right heart strain. Schwartz-Buckley Professor of Surgery, Vascular Division Do not use open or damaged packages. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Disclosures: None. Do not use in oxygen rich environment. 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.

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