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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use only water-based solvents for cleaning. 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. 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. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. Contraindications There are no contraindications. The decision was made to proceed with mechanical thrombectomy. It will reduce the service life of the PENUMBRA ENGINE. Prior to use, please refer to the . Do not use open or damaged packages. Figure 2. INDIGO SEPARATOR 4 is intended to be used with INDIGO CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Lightning 12 Intelligent Aspiration. CAT12 is a large . 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. This website is intended for US audience only. Use prior to the Use By date. 1. If the cause cannot be determined, withdraw the device or system as a unit. Associate Professor of Vascular Surgery
Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. 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. 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. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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). 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. Otherwise, this could result in degradation of the performance of this equipment. Schwartz-Buckley Professor of Surgery, Vascular Division
The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Next Article Precautions The device is intended for single use only. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. Precautions The device is intended for single use only. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Otherwise, this could result in degradation of the performance of this equipment. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. 1. Do not re-infuse blood or fluid from the canister back into the patient. (EXTRACT-PE). 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. D. Chris Metzger, MD
Ripal T. Gandhi, MD, FSIR, FSVM
When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. Figure 7. A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 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. Disclosures: None. University of Siena
Do not resterilize or reuse. INDIGO Aspiration System Indication for Use It is a welcome addition to our existing endovascular technologies for the treatment of acute PE. Created with Sketch. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Postoperative angiogram showing 100% resolution of thrombus. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. INDIGO Aspiration System Indication for Use Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Created with Sketch. 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. Director of Interventional Radiology
Lightning Intelligent Aspiration. COURSE OF TREATMENT. The patients echocardiogram showed normal RV size and function. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Do not resterilize or reuse. Contraindications There are no known contraindications. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . We gained access through the right CFV using a 14-F sheath. New York, New York
Use prior to the Use By date. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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). Disclosures: None. Miami, Florida
Disclosures: Consultant to Penumbra, Inc. 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. J Vasc Surg. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Return all damaged devices and packaging to the manufacturer/distributor. Do not use kinked or damaged devices. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Low-dose tPA was dripped into the left and right lobes of the PA. Do not block bottom air vents. doi: 10.1161/CIR.0000000000000707. Scans revealed a left lower extremity venous thrombus extending from the calf to the common iliac vein (CIV) (Figure 1). Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. Investor Relations: 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 Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). 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. Created with Sketch. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. Professor of Radiology and Surgery
The Indigo System with . 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. Do not use kinked or damaged devices. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. University of Minnesota
We performed a transjugular access with a 12-F introducer sheath. Catheters & Separators. Gianmarco de Donato, MD
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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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 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. Figure 2. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. The patients right leg was completely cold, insensate, and immobile from the thigh down. Do not use open or damaged packages. Figure 2. Figure 1. should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The Indigo Aspiration System Lightning 12 granted FDA approval. Mean PA pressure at the start of the case was 35 mm Hg. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Do not resterilize or reuse. 2021 Nov 1;48(5):e217571. Rotational thrombectomy of acute peripheral vascular occlusions using the ThromCat XT device: techniques, indications, and initial results. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Copyright 2022 Penumbra, Inc. All rights reserved. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. 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. 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. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. 1. Precautions The device is intended or single use only. Henderson Hospital
Created with Sketch. 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 . Department of Diagnostic, Molecular, and Interventional Radiology
12 F Laser Cut Hypotube Catheter. 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.. Lightning enables clot detection so the physician knows when . The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Chief of Vascular Surgery
Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Director, Venous Thromboembolic Center and Aortic Center
However, it has also been associated with an unsatisfying revascularization rate due to the detection of residual thrombus in distal vessels. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Poor distal runoff from acute thrombus. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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. 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). Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. New York, New York
Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. 2014;59:729-36. 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 CAT12 in the CIV. Disclosures: Owns public stock in Penumbra; consultant and course director for Penumbra, Inc. A 77-year-old woman presented to the emergency department with a history of esophageal varices and bleeding, contraindicating her for tissue plasminogen activator (tPA). With Lightning 8, we were able to clear the loft lobar branch and detect that we had established substantial inflow and outflow so we could move to the next affected lobe. 310-560-8176. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . 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.
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