When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not use open or damaged packages. Earlier in November 2020, Penumbra announced the receipt of 510(k) FDA clearance for an expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. J Vasc Interv Radiol. Created with Sketch. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. To ensure the most secure and best overall experience on our website, we recommend the latest versions of, https://www.penumbrainc.com/indigo-lightning/, http://www.penumbrainc.com/healthcare-professionals. Figure 2. The Indigo System has demonstrated high rates of revascularization with consistent success. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Equipment is not safe for MR use. Associate Professor of Vascular Surgery
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. Return all damaged devices and packaging to the manufacturer/ distributor. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. 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 the PENUMBRA ENGINE. If the cause cannot be determined, withdraw the device or system as a unit. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Lightning 12. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Thomas S. Maldonado, MD
PENUMBRA ENGINE Indication for Use In this next phase, Penumbra is set to broaden its reach on a global scale, and I am thrilled to join this excellent team and help accelerate the impact of its products.. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. Do not use open or damaged packages. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Do not use open or damaged packages. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. Do not use in oxygen rich environment. Figure 2. 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. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. Individual results may vary depending on patient-specific attributes. Gianmarco de Donato, MD
The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. D. Chris Metzger, MD
5. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. No modification of this equipment is allowed. Learn more about Lightning. Intravascular ultrasound (IVUS) revealed May-Thurner syndrome, which was treated with stenting in the CIV and EIV; 100% of the clot was resolved (, The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics (, Significant thrombus was aspirated from the Indigo CAT12 Aspiration Catheter (, May-Thurner narrowing of the left CIV was noted and treated with a Vici stent (Boston Scientific Corporation), with IVUS before treatment (, IVUS after thrombectomy and stenting showed a widely patent lumen (. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Contraindications There are no known contraindications. This website is intended for US audience only. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Semin Dial. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Return all damaged devices and packaging to the manufacturer/ distributor. Do not use kinked or damaged devices. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. For more information, visit https://www.penumbrainc.com/indigo-lightning/. The sustained aspiration from the Penumbra ENGINE provides constant uninterrupted full-vacuum aspiration throughout the procedure, addressing the constraints of syringe-based large-bore embolectomy, which include vacuum dropoff from the syringe filling with fluid. Next Article Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Return all damaged devices and packaging to the manufacturer/distributor. Thrombolysis is not a universal option for all patient groups, especially if the patient has an absolute or relative contraindication to a fibrinolytic agent. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Otherwise, this could result in degradation of the performance of this equipment. Lightning Intelligent Aspiration. With Lightning 8, we were able to clear the loft lobar branch and detect that we had established substantial inflow and outflow so we could move to the next affected lobe. Disclosures: Owns public stock in Penumbra; consultant and course director for Penumbra, Inc. A 77-year-old woman presented to the emergency department with a history of esophageal varices and bleeding, contraindicating her for tissue plasminogen activator (tPA). CAT12 is a large . A wire test was conducted in the right leg to determine the composition of the clot. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. Use prior to the Use By date. Restored distal flow to the left TPT. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 4 min read. Media Relations: The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Created with Sketch. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). 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. 4. Contraindications There are no known contraindications. A 57-year-old man presented with acute-onset left calf pain for the past 10 days and had recently taken a 4-hour flight. 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. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Indigo System has been designed to address the limitations of traditional treatment options. Siena, Italy
We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Otherwise, this could result in degradation of the performance of this equipment. Figure 2. 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. Director, Venous Thromboembolic Center and Aortic Center
With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. 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. Use prior to the Use By date. To prevent fire or shock hazard, use a replacement power cord of equal rating. Disclosures: Consultant to Penumbra, Inc. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Low-dose tPA was dripped into the left and right lobes of the PA. Figure 8. All Rights Reserved Privacy Policy, With Frank R. Arko III, MD; Patrick E. Muck, MD, RVT, FACS; Ripal T. Gandhi, MD, FSIR, FSVM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Michael S. Rosenberg, MD, FSIR, FACR; Eric Moldestad, MD; Gianmarco de Donato, MD; Thomas S. Maldonado, MD; D. Chris Metzger, MD, Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. Real-world case examples of Indigo System Lightning 12 Intelligent Aspiration for pulmonary embolism, plus insight into the science behind computer-aided mechanical aspiration and outlooks on PERT development in 2022. Warnings/Precautions The canister is intended for single use only. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Figure 1. The patients echocardiogram showed normal RV size and function. Postprocedural CT of the patients left pulmonary anatomy. Venogram showing CAT12 in the CIV. INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . Lightning is paired with CAT8 or CAT12. Created with Sketch. Throughout each case, Lightning provides procedural feedback via audiovisual cues. 2020;141(9):e139e596. should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Regarding the Chief Scientific and Medical Officer appointments, the company advised that Dr. Teigen joins Penumbra immediately and will contribute his extensive scientific and clinical expertise to ongoing and future research and development efforts. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; hemoptysis; respiratory failure; thromboembolic events. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Contraindications Not for use in the coronaries or the neurovasculature. 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. The Indigo Aspiration System, along with the Penumbra ENGINE and Indigo CAT8, provide a frontline treatment option for PE patients that can lower on-table PA pressures and reduce RV/LV ratios by 27.3%, per their investigational device exemption trial, EXTRACT-PE.1 The trial and our case experience at the University of Minnesota with CAT8 show that sustained aspiration with the Indigo System can provide safe mechanical relief in the treatment of PE. Mentors and Protgs: Conversations on Career and Craft With Alda L. Tam, MD, MBA, FRCPC, FSIR, FACR, The Patient Voice in Chronic Venous Disease Treatment: What We Have and Whats Coming Next, With Kathleen Gibson, MD, FACS, FAVLS, DABVLM; Al Compaan; and Manj Gohel, MBChB, MD, FRCS, FEBVS.
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