The latest generation of Penumbras continuous aspiration thrombectomy system features Indigo System Lightning 12 which combines the new Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. 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%. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. . Media Relations: 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. 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. Catheters & Separators. 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. 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. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Figure 1. Penumbra continues to lead the field of clot management by bringing highly innovative technology to address the challenges that we as physicians face while caring for our patients, commented Frank Arko, MD, in the company's announcement. To gain access into the lobar branches, a 5-F, 125-cm vertebral catheter over a 0.035-inch stiff, angled Glidewire (Terumo Interventional Systems) was used. Precautions The device is intended for single use only. Contraindications Not for use in the coronaries or the neurovasculature. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. COURSE OF TREATMENT. 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. With Ramona Gupta, MD, FSIR; Suman M. Wasan, MD, MS, FSVM; and Avianne Bunnell, MD, RPVI, By Andres Schanzer, MD, FACS, and Stphan Haulon, MD, PhD, By Dominique Fabre, MD, PhD; Thomas J. Postiglione, MD; and Stphan Haulon, MD, PhD, Unmet Needs in Ascending and Arch Disease, With Tilo Klbel, MD, PhD, and Joseph Bavaria, MD, With Giovanni Pratesi, MD; Martina Bastianon, MD; Sara Di Gregorio, MD; Gaddiel Mozzetta, MD; and Kimberly Malka, MD, PhD, With Tim Resch, MD, PhD; Sara L. Zettervall, MD, MPH; and Carlos Timaran, MD. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Venogram showing stents in the left CIV and EIV. It will reduce the service life of the PENUMBRA ENGINE. Figure 3. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. Circulation. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. 2023 Bryn Mawr Communications II, LLC. 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. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. 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). Heart disease and stroke statistics2020 update: a report from the American Heart Association. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. 2. 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. Icahn School of Medicine at Mount Sinai 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. Do not block bottom air vents. Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. CT revealed an occlusion in the popliteal artery (Figure 1). Figure 4. 1. Do not resterilize or reuse. 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. Frank R. Arko III, MD The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. Precautions The device is intended or single use only. 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. Director, Venous Thromboembolic Center and Aortic Center Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. This combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology. In PE cases, patients are often emergent and need interventions that provide immediate relief. Do not reuse. New York, New York Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the companys proprietary continuous, mechanical vacuum aspiration pump. Next Article Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Plus, get our latest issues & supplements delivered to your inbox each month. Precautions The device is intended or single use only. If the cause cannot be determined, withdraw the device or system as a unit. 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. Potential adverse . This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. CAT12 is . To prevent fire or shock hazard, use a replacement power cord of equal rating. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Maintain a constant infusion of appropriate flush solution. 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. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. Figure 2. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . Do not resterilize or reuse. This allows the operator to focus on the procedure and not on the canister. Chief, Vascular and Endovascular Surgery Eur J Vasc Endovasc Surg. Notably, Lightning 7 is designed . 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. Do not use open or damaged packages. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM 2020;141(9):e139e596. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 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%. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Lightning enables clot detection so the physician knows when . rosen011@umn.edu Do not use kinked or damaged devices. I feel privileged to join Penumbras unparalleled group of talented engineers and leaders, and I look forward to contributing my scientific knowledge to help solve challenging medical problems., Dr. Benenati commented, Im excited to join Penumbra at this very important time for the company, where its poised for growth, as it moves into the next generation of intelligent clot removal and expand into rehabilitation with the recent launch of the Real system. Use prior to the Use By date. All Rights Reserved Privacy Policy. 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. Copyright 2022 Penumbra, Inc. All rights reserved. Sanger Heart and Vascular Institute Investor Relations: The device is intended for single use only. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. (Photo: Business Wire). Equipment is not safe for MR use. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. PENUMBRA ENGINE Indication for Use The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Associate Professor of Vascular Surgery If the cause cannot be determined, withdraw the device or system as a unit. Ballad Health System CVA Heart & Vascular Institute When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Low-dose tPA was dripped into the left and right lobes of the PA. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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 (. Chief of Vascular Surgery Otherwise, this could result in degradation of the performance of this equipment. 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 (. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Atrium Health The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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. Restored distal flow to the left TPT. Enter your email address and we will contact you. Lightning is paired with CAT8 or CAT12. Figure 7. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Penumbra, Inc. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. Figure 1. 510-995-2461 Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. The INDIGO SEPARATOR is not intended for use as a guidewire. In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. Thomas S. Maldonado, MD 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Precautions The device is intended for single use only. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . 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. Eric Moldestad, MD Chief of Vascular Surgery Otherwise, this could result in degradation of the performance of this equipment. doi: 10.1161/CIR.0000000000000707. Mean PA pressure at the start of the case was 35 mm Hg. February 2022. Do not resterilize or reuse. betsy@merrymancommunications.com The Indigo Aspiration System Lightning 12 granted FDA approval. 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. Professor, Cardiovascular Surgery The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. The Indigo System with Lightning Intelligent Aspiration and Separators is indicated for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous . The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. Do not block bottom air vents. 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. 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. Copyright 2022 Penumbra, Inc. All rights reserved. Total aspiration time was 34 minutes. 1. New York University Langone Medical Center Do not use kinked or damaged devices. The goal of this study is to create a prospective multicenter study that provides safety and performance data on the Indigo System as a frontline percutaneous aspiration thrombectomy approach for ALI patients for whom immediate treatment and revascularization can maintain limb viability. . The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. Venogram showing thrombosis of the left FV and CFV. 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. 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. Do not use kinked or damaged devices. University of Minnesota No modification of this equipment is allowed. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 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. The patients echocardiogram showed normal RV size and function. 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 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. Copyright 2022 Penumbra, Inc. All rights reserved. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Saxon RR, Benenati JF, Teigen C, et al. Siena, Italy 5. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. To prevent fire or shock hazard, use a replacement power cord of equal rating. The Indigo System has been designed to address the limitations of traditional treatment options. This website is intended for US audience only. 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. 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 . Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Disclosures: None. 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. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. Miami Cardiac and Vascular Institute The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. 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. 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. Mean PA pressure postintervention was 21 mm Hg. The means of mains disconnect is to remove the power cord. Giri J, Sista A, Weinberg I, et al. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. 1Virani, S.S. et al. Internet Explorer presents a security risk. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. Director of Interventional Radiology Gianmarco de Donato, MD 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. 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). Warnings/Precautions The canister is intended for single use only. Sista A. 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. doi: 10.14503/THIJ-21-7571. right-arrow Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Scans revealed a left lower extremity venous thrombus extending from the calf to the common iliac vein (CIV) (Figure 1). 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. Figure 2. Disclosures: None. 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. 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). 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Dr. Benenati will join Penumbra on September 1, 2020, and will contribute to clinical and medical affairs strategies and advise upon global commercialization and market development activities.
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