Do not use in oxygen rich environment. 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. Penumbra Indigo System | Vascular Thrombectomy Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. doi: 10.14503/THIJ-21-7571. 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. We performed a transjugular access with a 12-F introducer sheath. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Professor of Radiology and Surgery The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Lightning 12: 12 F (4.04 mm) HTORQ (100 cm, 115 cm lengths) XTORQ (100 cm length) Lightning 7: 7 F (2.3 mm) XTORQ (130 cm length) CAT . 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. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Manhattan Veterans Administration Hospital Created with Sketch. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM The patients right leg was completely cold, insensate, and immobile from the thigh down. Penumbra, Inc. 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 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). Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. 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. With contributions from Edoardo Pasqui, MD; Carlo Setacci, MD; and Giancarlo Palasciano, MD, Surgical management of lower extremity acute limb ischemia (ALI) has been considered the preferred treatment for years. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Lightning enables clot detection so the physician knows when . Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Image showing the total thrombus removed. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. IVUS image showing a widely patent lumen after thrombectomy and stenting. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Pulmonary embolism, or PE, is a deadly condition causing blood clots within a patients lungs that has grown in prevalence during the COVID-19 pandemic. Cincinnati, Ohio Disclosures: None. 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. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . 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. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Disclosures: None. 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. 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. Figure 1. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Contraindications There are no contraindications. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. University of Siena 2013;26: E5-7. Precautions The device is intended or single use only. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Immediately after, Lightning with the Indigo System Catheter CAT8 was used to aspirate thrombus in the left PA (, Due to increased amounts of thrombus in the right lobe, the SEP8 was introduced to clear the lumen of the catheter (. NYU Langone Health MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. Lightning 12 Intelligent Aspiration. The Indigo Aspiration System Lightning 12 granted FDA approval. 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. Penumbra Launches Indigo System Lightning 12 and Appoints Medical and Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. 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. . 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. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism. Equipment is not safe for MR use. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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. Atrium Health Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Prior to use, please refer to the . Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. 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. 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. CAT3 advanced through the pedal loop (C). To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Venogram showing stents in the left CIV and EIV. This allows the operator to focus on the procedure and not on the canister. Restored distal flow to the left TPT. rosen011@umn.edu Use prior to the Use By date. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. The decision was made to proceed with mechanical thrombectomy. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. 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. Professor, Cardiovascular Surgery 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. Do not use open or damaged packages. Many of the first-generation mechanical endovascular devices for thrombus removal have failed to be adequately successful or have been associated with unacceptable complication rates. Figure 5. J Vasc Surg. From syringe aspiration to sustained aspiration and now to intelligent aspiration, the aspiration thrombectomy field has grown leaps and bounds, now finding itself at a place where the Indigo System with the Lightning Intelligent Aspiration optimizes the thrombus removal procedure by differentiating between thrombus and blood. New Indigo System By Penumbra - Medical Device News Magazine Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. Use prior to the Use By date. Rotational thrombectomy of acute peripheral vascular occlusions using the ThromCat XT device: techniques, indications, and initial results. Return all damaged devices and packaging to the manufacturer/distributor. Professor, FIU Herbert Wertheim College The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Contraindications There are no known contraindications. Plus, get our latest issues & supplements delivered to your inbox each month. Giri J, Sista A, Weinberg I, et al. Disclosures: Consultant to Penumbra, Inc. A 68-year-old man presented with a sudden coolness in both legs after stopping apixaban therapy for 3 days. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. Contraindications Not for use in the coronaries or the neurovasculature. 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. 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. (Credit: Business Wire.) Figure 1. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. Use prior to the Use By date. 2019;140:e774-e801. Do not block bottom air vents. PENUMBRA ENGINE Indication for Use 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. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. 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. Ripal T. Gandhi, MD, FSIR, FSVM 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). This website is intended for US audience only. Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Use prior to the Use By date. This website is intended for US audience only. Preprocedural CT of the patients left pulmonary anatomy. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. Figure 4. For more information, visit https://www.penumbrainc.com/indigo-lightning/. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Lightning is paired with CAT8 or CAT12. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Lightning 12 and Separator 12 Now Indicated for Treatment of PE, The Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Do not use kinked or damaged devices. Las Vegas, Nevada CT revealed bilateral ALI (Figure 1). 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. Director, Venous Thromboembolic Center and Aortic Center Do not use open or damaged packages. Investor Relations: The Indigo CAT8 XTORQ was advanced over the select catheter and used in both the right and left PAs. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. 4 min read. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. 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. University of Minnesota 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). Do not use in oxygen rich environment. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). Precautions The device is intended for single use only. 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. Schwartz-Buckley Professor of Surgery, Vascular Division Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Use only water-based solvents for cleaning. The results may not be predictive of all patients. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo In PE cases, patients are often emergent and need interventions that provide immediate relief. Executive Vice Chairman 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. In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Return all damaged devices and packaging to the manufacturer/distributor. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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.. Miami Cancer Institute Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. 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. 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.
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