Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Return all damaged devices and packaging to the manufacturer/distributor. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use New York, New York 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. Frank R. Arko III, MD 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. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. Figure 1. Notably, Lightning 7 is designed . Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Associate Clinical Professor, University of South Florida College of Medicine Penumbra, Inc. July 14, 2020P enumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the company's next-generation aspiration system for peripheral thrombectomy.. 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. The new HTORQ angle is complemented by the large lumen when accessing wall-adherent thrombus in the venous space. We gained access through the right CFV using a 14-F sheath. 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Do not resterilize or reuse. Program Director, Vascular Fellowship & Integrated Residency Lightning 12. Otherwise, this could result in degradation of the performance of this equipment. A 57-year-old man presented with acute-onset left calf pain for the past 10 days and had recently taken a 4-hour flight. The 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. 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. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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 . Return all damaged devices and packaging to the manufacturer/ distributor. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Chief of Vascular Surgery 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. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Equipment is not safe for MR use. 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. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Do not use in oxygen rich environment. 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). Otherwise, this could result in degradation of the performance of this equipment. The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Plus, get our latest issues & supplements delivered to your inbox each month. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. The Indigo System with . Created with Sketch. Potential adverse . 310-560-8176. For more information, visit https://www.penumbrainc.com/indigo-lightning/. Do not block bottom air vents. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. 1Virani, S.S. et al. The decision was made to proceed with mechanical thrombectomy. Disclosures: None. 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. The Indigo System aspiration catheter is available in a range of lengths and diameters that, when connected to the proprietary Penumbra Aspiration Pump, may help atraumatically remove the thrombus under continuous aspiration. Catheters & Separators. 2023 Bryn Mawr Communications II, LLC. In PE cases, patients are often emergent and need interventions that provide immediate relief. The Indigo Aspiration System provides a treatment option that is now cleared by the FDA to treat PE. 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 . CT revealed an occlusion in the popliteal artery (Figure 1). The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. 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. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. 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 EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Do not use open or damaged packages. The system is indicated for the removal of fresh, soft emboli and thrombi . 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. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Patrick E. Muck, MD, RVT, FACS The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. 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. 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 (. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. Contraindications There are no contraindications. Poor distal runoff from acute thrombus. Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 2014;59:729-36. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. The INDIGO SEPARATOR is not intended for use as a guidewire. 2023 Bryn Mawr Communications II, LLC. 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. 1. de Donato G, Setacci F, Sirignano P, Galzerano G, Massaroni R, Setacci C. The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia. 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. 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. 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. 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. 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. 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Do not re-infuse blood or fluid from the canister back into the patient. Kingsport, Tennessee When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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 and Separator 12 Now Indicated for Treatment of PE, The Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. 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. 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. Created with Sketch. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Angiography after Indigo power aspiration and popliteal aneurysm repair with a stent graft (Viabahn, Gore & Associates) revealed a patency of the tibial (A) and plantar (B) vessels. 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. LIGHTNING Aspiration Tubing Indication for Use The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. New York, New York Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. Disclosures: None. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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.. 12 F Laser Cut Hypotube 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.. The means of mains disconnect is to remove the power cord. The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Poor flow through the left TPT. 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. Individual results may vary depending on patient-specific attributes. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow 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. Use only water-based solvents for cleaning. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. Rotational thrombectomy of acute peripheral vascular occlusions using the ThromCat XT device: techniques, indications, and initial results. Do not resterilize or reuse. In particular, the Indigo catheters vary from 3 to 8 Fenabling the operator to remove thrombus from small vessels such as the pedal arch but also from large vessels such as the aorta or iliac arteries, due to the circumferential aspiration from the tip shapes offered in CAT8. 2019;140:e774-e801. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Venogram showing CAT12 in the CIV. Circulation. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. Contraindications There are no known contraindications. 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. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. Associate Professor of Radiology and Surgery February 2022. Do not use kinked or damaged devices. 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. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. . Do not use in oxygen rich environment. CAT3 advanced through the pedal loop (C). Miami Cardiac and Vascular Institute Cincinnati, Ohio Created with Sketch. Do not use in an oxygen rich environment. Use prior to the Use By date. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 5. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. 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. Low-dose tPA was dripped into the left and right lobes of the PA. Professor, FIU Herbert Wertheim College All Rights Reserved Privacy Policy, With Frank R. Arko III, MD; Patrick E. Muck, MD, RVT, FACS; Ripal T. Gandhi, MD, FSIR, FSVM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Michael S. Rosenberg, MD, FSIR, FACR; Eric Moldestad, MD; Gianmarco de Donato, MD; Thomas S. Maldonado, MD; D. Chris Metzger, MD, Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM. Do not resterilize or reuse. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use kinked or damaged devices. 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. CAT 12 is a . Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. Saxon RR, Benenati JF, Teigen C, et al. Ballad Health System CVA Heart & Vascular Institute Figure 3. Image showing the total thrombus removed. Lightning Intelligent Aspiration. Miami Cancer Institute Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. 1. Las Vegas, Nevada INDIGO Aspiration System Indication for Use Return all damaged devices and packaging to the manufacturer/distributor. Sista A. Do not use in oxygen rich environment. 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. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . Use prior to the Use By date. (Credit: Business Wire.) Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. CAT12 is a large . Icahn School of Medicine at Mount Sinai 2020;141(9):e139e596. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. 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. Merryman Communications Disclosures: None. 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. Powered by the Penumbra Engine, Lightning 7 and Lightning 12 combine the new Indigo system CAT7 and CAT12 aspiration catheters with Lightning intelligent aspiration, a computer-aided clot detection technology that can differentiate between clot and blood. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy.
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