Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Michael S. Rosenberg, MD, FSIR, FACR 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. 5. Contraindications There are no known contraindications. This website is intended for US audience only. We performed a transjugular access with a 12-F introducer sheath. doi: 10.14503/THIJ-21-7571. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. CAT 12 is a . Next Article 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. Do not use open or damaged packages. 510-995-2461 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. This website is intended for US audience only. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Do not re-infuse blood or fluid from the canister back into the patient. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Return all damaged devices and packaging to the manufacturer/distributor. Figure 2. CT showed a bilateral PE with right heart strain. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . 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. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Warnings/Precautions The canister is intended for single use only. Scans revealed a left lower extremity venous thrombus extending from the calf to the common iliac vein (CIV) (Figure 1). Dek Z, Strube H, Sadeghi-Azandaryani M, et al. It will reduce the service life of the PENUMBRA ENGINE. 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. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. Created with Sketch. 12 F Laser Cut Hypotube Catheter. 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. Miami Vascular Specialists The Indigo System has demonstrated high rates of revascularization with consistent success. Pulmonary embolism (PE) is a condition that occurs when blood clots, typically traveling from the veins in the legs, get caught in the arteries of the lungs. A 67-year-old woman with a history of venous thrombus and iliac venous stenting presented with significant recurrent left lower extremity venous thrombus, and the patients symptoms did not significantly improve with anticoagulation alone. Risk Information. Lightning 12 Intelligent Aspiration. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. This combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology. 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. Disclosures: None. The INDIGO SEPARATOR is not intended for use as a guidewire. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. 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 (. Disclosures: None. 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). Copyright 2022 Penumbra, Inc. All rights reserved. The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. Notably, Lightning 7 is designed . The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. The INDIGO SEPARATOR is not intended for use as a guidewire. 2. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. 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%. Use only water-based solvents for cleaning. The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Total aspiration time was 34 minutes. Media Relations: In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. 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 contraindications. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. 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 fundamental components of the Lightning 12 Intelligent Aspiration system are the Engine pump, the Lightning control unit, and the CAT 12 HTORQ 12F catheter. Chief, Vascular and Endovascular Surgery Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. Professor of Radiology and Surgery Otherwise, this could result in degradation of the performance of this equipment. INDIGO Aspiration System Indication for Use Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays. 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. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. Eric Moldestad, MD Do not block bottom air vents. Figure 4. Figure 8. Scan showing preoperative left venous thrombus. New York, New York In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. 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. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Enter your email address and we will contact you. Figure 6. Schwartz-Buckley Professor of Surgery, Vascular Division right-arrow Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 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. Kingsport, Tennessee A wire test was conducted in the right leg to determine the composition of the clot. 310-560-8176. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Internet Explorer presents a security risk. Low-dose tPA was dripped into the left and right lobes of the PA. The patient had a history of lower left extremity venous thrombus dating back to 2013, with chronic residual nonocclusive popliteal vein thrombus in 2018. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Do not use in an oxygen rich environment. 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. Department of Medicine, Surgery and Neuroscience 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. Maintain a constant infusion of appropriate flush solution. Do not use kinked or damaged devices. Otherwise, this could result in degradation of the performance of this equipment. Engineered to be trackable, deliverable, and torqueable, the CAT8s atraumatic tip can navigate the lobar anatomy of the PA to help establish inflow and outflow, helping to restore patient vitals to normal. Minneapolis, Minnesota 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 (. Do not use kinked or damaged devices. . Sista A. Equipment is not safe for MR use. Semin Dial. Circulation. Chief of Vascular Surgery Massive intravascular hemolysis with mechanical rheolytic thrombectomy of a hemodialysis arteriovenous fistula. 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. No modification of this equipment is allowed. A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. 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. Desert Radiology The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Copyright 2022 Penumbra, Inc. All rights reserved. Heart disease and stroke statistics2020 update: a report from the American Heart Association. Department of Diagnostic, Molecular, and Interventional Radiology Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. doi: 10.1111/j.1525-139X.2012.01104.x. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. 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. 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. 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 . If the cause cannot be determined, withdraw the device or system as a unit. Otherwise, this could result in degradation of the performance of this equipment. Gianmarco de Donato, MD Figure 3. Return all damaged devices and packaging to the manufacturer/distributor. Return all damaged devices and packaging to the manufacturer/ distributor. Contraindications There are no known contraindications. 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. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. This website is intended for US audience only. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. doi: 10.1161/CIR.0000000000000707. 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. Saxon RR, Benenati JF, Teigen C, et al. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Postprocedural CT of the patients left pulmonary anatomy. 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. 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.. Created with Sketch. 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. When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Do not use open or damaged packages. Maintain a constant infusion of appropriate flush solution. The Indigo Aspiration System, along with the Penumbra ENGINE and Indigo CAT8, provide a frontline treatment option for PE patients that can lower on-table PA pressures and reduce RV/LV ratios by 27.3%, per their investigational device exemption trial, EXTRACT-PE.1 The trial and our case experience at the University of Minnesota with CAT8 show that sustained aspiration with the Indigo System can provide safe mechanical relief in the treatment of PE. The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus. Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. Henderson Hospital Use prior to the Use By date. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. 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. We gained access through the right CFV using a 14-F sheath. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. investors@penumbrainc.com 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. PENUMBRA ENGINE Indication for Use Do not use in oxygen rich environment. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. 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. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. 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). Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Poor distal runoff from acute thrombus. 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.
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indigo system lightning 12