Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use STRIDE is currently ongoing. 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 use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Giri J, Sista A, Weinberg I, et al. CAT12 is a large . Created with Sketch. doi: 10.14503/THIJ-21-7571. 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. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Do not block bottom air vents. 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. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. All Rights Reserved Privacy Policy. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not resterilize or reuse. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. 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. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. Penumbra, Inc. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. Lightning 12 combines the 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. 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. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Do not use open or damaged packages. Sustained aspiration from the Indigo System provides physicians with an alternative option for patients who are not ideal candidates for lytics or open embolectomy and provides a frontline therapy option that still preserves the use of any adjunctive therapy. University of Siena Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. doi: 10.1161/CIR.0000000000000707. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Minneapolis, Minnesota Previous Article, Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE, With James Horowitz, MD, FACC; Mitchell J. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Circulation. 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). Professor, FIU Herbert Wertheim College Low-dose tPA was dripped into the left and right lobes of the PA. We performed a transjugular access with a 12-F introducer sheath. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Figure 7. 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. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; 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; respiratory failure; peripheral thromboembolic events. Percutaneous manual thromboaspiration was the first technique proposed, followed by a series of percutaneous mechanical thrombectomy devices based on a different mechanism of action (mechanical fragmentation, aspiration, rheolytic thrombectomy, and their combinations). 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. 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. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 26, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 7, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 3, 2020, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC on November 2, 2020. Director, Venous Thromboembolic Center and Aortic Center Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. If the cause cannot be determined, withdraw the device or system as a unit. 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 decision was made to proceed with mechanical thrombectomy. CAT12 is . Prior to use, please refer to the . 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 the thrombus. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Use prior to the Use By date. MHealth Fairview System Medical Director for Interventional Radiology Operations The means of mains disconnect is to remove the power cord. Potential adverse . Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). The Indigo System has been designed to address the limitations of traditional treatment options. Good Samaritan Hospital Do not reuse. IVUS image showing a widely patent lumen after thrombectomy and stenting. 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. 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. 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. 1Virani, S.S. et al. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Disclosures: Consultant to Penumbra, Inc. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Figure 1. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Aspiration may also be performed in conjunction with an Indigo System Separator (Penumbra, Inc.) to allow for constant clearing of thrombus from the lumen of the catheter. 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. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 2. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Do not resterilize or reuse. Eur J Vasc Endovasc Surg. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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 (. 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. Internet Explorer presents a security risk. Program Director, Vascular Fellowship & Integrated Residency 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. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. 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. CAT 12 is a . Heart disease and stroke statistics2020 update: a report from the American Heart Association. The results may not be predictive of all patients. The Indigo CAT8 XTORQ was advanced over the select catheter and used in both the right and left PAs. The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. If the cause cannot be determined, withdraw the device or system as a unit. The system is indicated for the removal of fresh, soft emboli and thrombi . PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. Poor distal runoff from acute thrombus. 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. Disclosures: None. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. In this case, the PE patient had an extremely high PA pressure of 35 mm Hg, which we were able to significantly reduce by 40%. Las Vegas, Nevada The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . However, these hybrid procedures include the invasiveness of open surgery and carry the risk of incomplete thrombus removal or vessel damage.1, Consequently, many new endovascular devices have been proposed to increase treatment success, decrease complications, and rapidly improve perfusion. Thomas S. Maldonado, MD Lightning 12 and Separator 12 are designed for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. The clot detection algorithm paired with the audiovisual cues lets the physician know when the catheter is in thrombus versus when it is in blood. Miami Cardiac and Vascular Institute Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. 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. Do not use kinked or damaged devices. Lightning 12 combines the Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. When 4 solid illuminated bars on the . 5. Thrombotic disease puts patients at high risk of . Miami Cancer Institute . Interventional Radiology Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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. 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.. COURSE OF TREATMENT. When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Postprocedural CT of the patients left pulmonary anatomy. The CAT familyof catheters is the foundation of Penumbras Indigo System. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Figure 2. 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. Lightning enables clot detection so the physician knows when . Do not resterilize or reuse. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Lightning Intelligent Aspiration. Do not use kinked or damaged devices. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Figure 3. Gianmarco de Donato, MD Precautions The device is intended for single use only.
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