CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. 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. Lightning 12 combines the Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Disclosures: None. Embolization: Expanding Evidence and Awareness. Desert Radiology July 14, 2020Penumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the companys next-generation aspiration system for peripheral thrombectomy. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Risk Information. It is a welcome addition to our existing endovascular technologies for the treatment of acute PE. Ask the Experts: How Do You Treat (and Avoid) Recurrent Varicose Veins? Contraindications There are no known contraindications. 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. 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. Associate Professor of Radiology and Surgery 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. Do not resterilize or reuse. 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. 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. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. Otherwise, this could result in degradation of the performance of this equipment. Do not reuse. Disclosures: None. Return all damaged devices and packaging to the manufacturer/distributor. Figure 6. Figure 2. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. 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. Maintain a constant infusion of appropriate flush solution. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. CT revealed bilateral ALI (Figure 1). Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. Professor of Radiology and Surgery Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. Warnings/Precautions The canister is intended for single use only. Chief of Vascular Surgery 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 clot detection algorithm paired with the audiovisual cues lets the physician know when the catheter is in thrombus versus when it is in blood. 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. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. 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. Earlier in November 2020, Penumbra announced the receipt of 510(k) FDA clearance for an expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. The decision was made to proceed with mechanical thrombectomy. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM trial. 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 . Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. This website is intended for US audience only. 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. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM Figure 5. Semin Dial. 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. Do not block bottom air vents. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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.. right-arrow The means of mains disconnect is to remove the power cord. 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. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. INDIGO Aspiration System Indication for Use . . 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. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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%. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Enter your email address and we will contact you. 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; 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. At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. 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 . Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. The device is intended for single use only. Associate Clinical Professor, University of South Florida College of Medicine Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Media Relations: No modification of this equipment is allowed. Figure 2. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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 fundamental components of the Lightning 12 Intelligent Aspiration system are the Engine pump, the Lightning control unit, and the CAT 12 HTORQ 12F catheter. 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). 2. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. Program Director, Vascular Fellowship & Integrated Residency Ripal T. Gandhi, MD, FSIR, FSVM Do not use kinked or damaged devices. This website is intended for US audience only. Heart disease and stroke statistics2020 update: a report from the American Heart Association. Potential adverse . 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. 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. University of Minnesota The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Mean PA pressure at the start of the case was 35 mm Hg. The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Do not use in oxygen rich environment. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Cincinnati, Ohio To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Charlotte, North Carolina Interventional Radiology 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. 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. 510-995-2461 Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Do not reuse. Such results give more evidence for a shift of treatment recommendation toward endovascular options in the patients with ALI, as already suggested by the recent European Society of Cardiology/European Society for Vascular Surgery guidelines. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Diagn Interv Radiol. Previous Article, Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE, With James Horowitz, MD, FACC; Mitchell J. Venogram showing thrombosis of the left FV and CFV. Total aspiration time was 34 minutes. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Do not use open or damaged packages. D. Chris Metzger, MD 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. Created with Sketch. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Eur J Vasc Endovasc Surg. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. To prevent fire or shock hazard, use a replacement power cord of equal rating. Figure 7. Contraindications Not for use in the coronaries or the neurovasculature. When 4 solid illuminated bars on the . 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. Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. 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. 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. 5. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. New York, New York If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Associate Professor of Vascular Surgery Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Figure 1. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 2. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. Disclosures: Consultant to Penumbra, Inc. Kingsport, Tennessee This website is intended for US audience only. 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). 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. 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. 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. The means of mains disconnect is 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. For more information, visit https://www.penumbrainc.com/indigo-lightning/. As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The Indigo System has been designed to address the limitations of traditional treatment options. 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. Postprocedural CT of the patients left pulmonary anatomy. Ballad Health System CVA Heart & Vascular Institute Penumbra, Inc. Executive Vice Chairman 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. 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. When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Siena, Italy Professor, FIU Herbert Wertheim College 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. Giri J, Sista A, Weinberg I, et al. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Director of Interventional Radiology The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 2019;140:e774-e801. 12 F Laser Cut Hypotube Catheter. Industry Prospects 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.