indigo system lightning 12

Internet Explorer presents a security risk. 1. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Next Article Created with Sketch. 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. Penumbra Augments Vascular Franchise with Latest Indigo System Launch Image showing the total thrombus removed. 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 (. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. 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. This website is intended for US audience only. Henderson Hospital Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. In such a case, the use of multiple catheters (CAT8 for popliteal, CAT6 for tibials, and CAT3 for plantars) was particularly helpful (Figure 2 and Figure 3). PENUMBRA ENGINE Indication for Use Otherwise, this could result in degradation of the performance of this equipment. This website is intended for US audience only. Do not use open or damaged packages. Veryan Medical Will Support Commercialization of Walk Vasculars Jeti Thrombectomy System in Germany, left-arrow Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. The PRISM trial, a retrospective case analysis assessing the rate of TIMI 2-3 flow after the use of Indigo and specifically the XTRACT technique, showed an 87.2% rate of revascularization post-Indigo and subsequent treatment of underlying stenosis in the same setting.1 The newly completed study studying the same primary outcome as PRISM, the INDIAN registry, showed an even higher rate of revascularization, 88.7%.2 Sustained aspiration for ALI could potentially increase the revascularization rate by serving as an effective single-session frontline option. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The system is indicated for the removal of fresh, soft emboli and thrombi . Use prior to the Use By date. Figure 1. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. of Medicine The reasons have been mainly related to the limited trackability, the risk of vessel injury, and/or the incidence of incomplete revascularization, and the risk of bleeding and hemolysis.2,3. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Do not block bottom air vents. 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. Figure 2. Warnings/Precautions The canister is intended for single use only. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. 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. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. Lightning 12 combines the new 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 . The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. 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 open or damaged packages. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 4. 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). Bjrck M, Earnshaw JJ, Acosta S, et al. 5. A preliminary analysis of the first 143 patients showed a technical success (defined as complete or near-complete revascularizationTIMI 2-3 flow) after thromboaspiration procedure alone in 89.5%. 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. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Figure 2. Director, Venous Thromboembolic Center and Aortic Center New York, New York In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Total aspiration time was 34 minutes. It will reduce the service life of the PENUMBRA ENGINE. Individual results may vary depending on patient-specific attributes. Computer-Aided Thrombus Removal Using Penumbra's Lightning 7 and Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The Separator is specifically designed for mechanical clot engagement and is particularly helpful in acute-on-chronic thrombosis, in-stent/in-bypass fresh occlusion, and in below-the-knee (BTK) and all the way to the pedal arch thrombi localization (Figure 1). Giri J, Sista A, Weinberg I, et al. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. 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. 2023 Bryn Mawr Communications II, LLC. The Indigo CAT8 XTORQ was advanced over the select catheter and used in both the right and left PAs. Figure 2. Catheters & Separators. Thrombotic disease puts patients at high risk of . Indigo System - Vascupedia Miami Vascular Specialists In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. 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. Rethinking Thrombus Removal With the Indigo System: Introducing Professor of Radiology and Surgery Good Samaritan Hospital Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Do not use open or damaged packages. Precautions The device is intended or single use only. Return all damaged devices and packaging to the manufacturer/distributor. Figure 4. The Indigo System has demonstrated high rates of revascularization with consistent success. CT revealed bilateral ALI (Figure 1). The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. 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. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. According to Penumbra, Lightning 12 combines the company's new Indigo System Cat 12 aspiration catheter with its Lightning Intelligent Aspiration to enable physicians to focus on optimizing thrombus removal using the systems clot detection mechanism. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Next Article If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. 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. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. 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 unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which . Figure 3. Associate Professor of Vascular Surgery 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; and D. Chris Metzger, MD. Diagn Interv Radiol. 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.. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Mean PA pressure postintervention was 21 mm Hg. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. Do not use open or damaged packages. Interventional Radiology By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. 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. investors@penumbrainc.com Associate Clinical Professor, University of South Florida College of Medicine Figure 1. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Otherwise, this could result in degradation of the performance of this equipment. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body. Disclosures: None. Large-bore embolectomy, when paired with a syringe, has led to variable results, with questions regarding the ideal technique to achieve a uniform state of vacuum aspiration.1 The catheters used to aspirate should ideally be atraumatic and easily deliverable to be able to access and establish flow through the lobar branches of the pulmonary artery (PA), reducing right heart strain and PA pressure. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. J Vasc Interv Radiol. Otherwise, this could result in degradation of the performance of this equipment. Designed for single session arterial thrombus removal, New angled tip shape for maximized clot extraction, Dual pressure sensors for real-time flow monitoring, Large lumen size and circumferential sweep enables maximized thrombus engagement, Multi-pitch hypotube for 1:1 torque transfer and advanced deliverability, Indicated for the treatment of pulmonary embolism. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. 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). Lightning 12 combines the new 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. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Use prior to the Use By date. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Saxon RR, Benenati JF, Teigen C, et al. Do not re-infuse blood or fluid from the canister back into the patient. Sanger Heart and Vascular Institute Penumbra, the Penumbra P logo, Indigo, CAT, Separator, Lightning, and Penumbra ENGINE are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn. Scan showing preoperative left venous thrombus. 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 next generation aspiration system for peripheral thrombectomy. For bilateral occlusions where thrombus is laced throughout the SFA in both legs and with potential for acute-to-chronic occlusion distally, the Indigo System provides a frontline treatment option that potentially preserves limb viability. CAT12 is a large . This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. 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). Poor flow through the left TPT. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. However, it has also been associated with an unsatisfying revascularization rate due to the detection of residual thrombus in distal vessels. Carrera LA, Reddy R, Pamoukian VN, et al. Schwartz-Buckley Professor of Surgery, Vascular Division Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Lightning is paired with CAT8 or CAT12. The decision was made to proceed with mechanical thrombectomy. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Otherwise, this could result in degradation of the performance of this equipment. 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 (. Lightning enables clot detection so the physician knows when . 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. 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. New Indigo System By Penumbra - Medical Device News Magazine Associate Professor of Radiology and Surgery This website is intended for US audience only. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. Penumbra augments vascular franchise with latest Indigo System launch The patients echocardiogram showed normal RV size and function. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo Disclosures: None. Siena, Italy This allows the operator to focus on the procedure and not on the canister. Mean PA pressure at the start of the case was 35 mm Hg. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Do not use kinked or damaged devices. The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use kinked or damaged devices. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The results may not be predictive of all patients. 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. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. 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. Preprocedural CT of the patients left pulmonary anatomy. Do not use in oxygen rich environment. Do not use kinked or damaged devices. MHealth Fairview System Medical Director for Interventional Radiology Operations Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. 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. Contraindications There are no known contraindications. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism. The INDIGO SEPARATOR is not intended for use as a guidewire. Penumbra's Indigo System With Lightning Intelligent Aspiration Use only water-based solvents for cleaning. Lightning 12 with Intelligent Aspiration is a giant leap forward for the field of thrombectomy, and we have been very impressed with the early results at Sanger.. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. COURSE OF TREATMENT. Use prior to the Use By date. Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. 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. 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. 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. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Charlotte, North Carolina Do not use in an oxygen rich environment. Betsy Merryman Figure 3. D. Chris Metzger, MD Do not use open or damaged packages. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. Venogram showing thrombosis of the left FV and CFV. Miami, Florida The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. Penumbra's newest generation of Indigo aspiration system receives FDA Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. Department of Medicine, Surgery and Neuroscience 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW Venogram showing stents in the left CIV and EIV. New York University Langone Medical Center Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Do not use kinked or damaged devices. 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions.

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