2021 Nov 1;48(5):e217571. INDIGO SYSTEM LIGHTNING 12 QEW: Back to Search Results: Model Number LITNG12XTORQ100-A: Device Problem Circuit Failure (1089) Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or The Lightning system (currently available for the CAT 8 and CAT 12 catheters) achieves an 18:1 fluid-loss savings over the original Dynamic Aspiration Tubing, based on benchtop testing. Precautions The device is intended or single use only. Therefore, the rhv was removed. With a lot of clots to clear, Dr. Stout worked on Lee for about an hour using the new technology. If lightning hits a line at a time when the system voltage happens to be at a peak of the opposite polarity, the arrester will not go into complete conduction until the voltage impulse has compensated for system voltage. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Otherwise, this could result in degradation of the performance of this equipment. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. The final component of the Lightning 12 system is the CAT 12 catheter (Fig. Powered by the Penumbra Engine, Lightning 7 and Lightning 12 combine the new Indigo system CAT7 and CAT12 aspiration catheters with Lightning intelligent aspiration, a computer-aided clot detection technology that can differentiate between clot and blood. The Indigo System Lightning 12 is Penumbras newest generation aspiration system for peripheral thrombectomy. Contraindications There are no known contraindications. doi: 10.14503/THIJ-21-7571. Powered by the Penumbra Engine, Lightning 7 and Lightning 12 combine the new Indigo system CAT7 and CAT12 aspiration catheters with Lightning intelligent aspiration, a computer-aided clot detection technology that can differentiate between clot and blood. Lightning 12 provides physicians with an integrated system that not only removes large amounts of thrombus but also detects and manages clot removal, said Jay Mathews, M.D., interventional cardiologist, Manatee Memorial Hospital, Florida. Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. As part of the Indigo Aspiration System, Lightning 12 is now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism. Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the systems clot detection mechanism. On 20 November, 2020, Penumbras newest generation of Indigo Aspiration System, Lightning 12, received FDA clearance for the treatment of pulmonary embolism (PE). Courtesy: The Indigo System Lightning 12, powered by the Penumbra ENGINE. Lightning 12 combines the Indigo System CAT12 aspiration catheter with lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the systems unique clot detection mechanism. As part of the Indigo aspiration system, Lightning 12 (Indigo system CAT 12 aspiration catheter with Lightning intelligent aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, as well as for the treatment of pulmonary embolism (PE). It would have taken us hours with open surgery or other devices, he said. Published. The patient was undergoing a thrombectomy procedure in the inferior vena cava (ivc) using a rotating hemostasis valve (rhv) packaged with the lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12), a non-penumbra sheath and a guidewire. Penumbra, Inc. GlobalData estimates that in 2019, almost 200,000 cases of PE occurred in the US alone, and this incidence has increased during the Covid-19 pandemic. GlobalData estimates that in 2019, almost 200,000 cases of PE occurred in the US alone, and this incidence has increased during the Covid-19 pandemic. Penumbra Announces the European Launch of the Indigo System With Lightning 7 and Lightning 12 Intelligent Aspiration Posted: 04/14/2022 Journal Watch 2022 The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the systems clot detection mechanism. The Indigo System Lightning 12 is the companys next generation aspiration system for peripheral thrombectomy. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 12 (cat12). Penumbra (PEN) said its Indigo Aspiration System with Lightning 7 and Lightning 12 secured CE Mark (Conformit Europenne) and The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. 2). From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. ALAMEDA, Calif., April 14, 2022--Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in On a 12.47Y/7.2-kV system, this adds another 2 (7.2) = 10.18 kV to the traveling wave. The Indigo Systems proprietary Separator technology, Separator 12 is also available with Lightning 12 and is designed to enable unobstructed aspiration for the duration of the procedure. INDIGO SYSTEM LIGHTNING 12 QEW: Back to Search Results: Model Number LITNG12HTORQ115-A: Device Problems Circuit Failure (1089); Obstruction of Flow (2423) Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582) Event Date 09/02/2020: During the procedure, the physician noticed blood leaking through the rhv. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. The Indigo System Lightning 12 is the companys next generation aspiration system for peripheral thrombectomy. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Mar 19, 2021 1:06PM EDT. The Indigo System Lightning 12 is the companys next generation aspiration system for peripheral thrombectomy. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. 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. During the procedure, as the rotating hemostasis valve (rhv) was being loosened and tightened accordingly to take the separator wire in and out, the rhv came apart and was leaking. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration The fundamental components of the Lightning 12 Intelligent Aspiration system are the Engine pump, the Lightning control unit, and the CAT 12 HTORQ 12F catheter. This animation shows how the system finds and removes a clot. On 20 November 2020, Penumbras newest generation of Indigo Aspiration System, Lightning 12, received US Food and Drug Administration (FDA) clearance for the treatment of pulmonary embolism (PE). Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Catheters & Separators. The Indigo System's proprietary Separator technology, Separator 12 is also available with Lightning 12 and is designed to enable unobstructed aspiration for the duration of Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism.
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