2017;377:2240-2252. function gtag(){dataLayer.push(arguments);} The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. Use only water-based solvents for cleaning. St. Joseph Hospital If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. 1. chronic clot, atherosclerotic plaque) Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. These pages are not intended for patients or for members of the general public. Warnings/Precautions Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . 3. Contraindications Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). Penumbra ENGINE Indication For Use 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Mechanical Thrombectomy. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Waqas R. Qureshi, MD, MS Caution: 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. The Swan-Ganz catheter was exchanged over a long V18 wire. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. Flow through left circumflex artery post-CAT RX. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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 . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Figure 3. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Los Angeles, California Otherwise, this could result in degradation of the performance of this equipment. SVG occlusions can be challenging to resolve using traditional treatment modalities. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Disclosures: None. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Vedantham S, Goldhaber SZ, Julian JA, et al. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Worcester, Massachusetts The INDIGO SEPARATOR 4 is not intended for use as a guidewire. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. This content is not intended to offer professional medical advice. The device is intended for single use 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. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The results may vary depending on a variety of patient specific attributes. 0, and 37. The CAT family of catheters is the foundation of Penumbra's Indigo System. The procedure can be performed quickly,1 which is important for symptomatic patients. Enter your email address and we will contact you. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Mathews SJ, Brown C, Kolski B, et al. 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. 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. UMassMemorial University Campus If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Potential Adverse Events The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Do not use kinked or damaged devices. Conclusions: evaluation of the cat8 revealed that the device was fractured. The CAT family of catheters is the foundation of Penumbra's Indigo System. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The product-specific content of this website is intended for use by healthcare professionals only. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. Do not use kinked or damaged devices. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Use prior to the Use By date. J Vasc Interv Radiol. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer/ distributor. 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. Figure 3. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. INDIGO Aspiration System Intended Use Final angiographic result of SVG. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. Do not use kinked or damaged devices. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Penumbra's not relying on software alone. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. INDIGO Aspiration Tubing: 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. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Maintain a constant infusion of appropriate flush solution. Jolly SS, Cairns JA, Yusuf S, et al. gtag('js', new Date()); Final angiogram after stent placement showing resolution of underlying disease. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Copyright 2023 Penumbra, Inc. All rights reserved. N Engl J Med. Contraindications Not for use in the coronaries or the neurovasculature. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Next Article All Rights Reserved Privacy Policy, With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; Suhail Dohad, MD, FACC. 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 . Jawairia Sahar K. Mirza, MBBS 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. Figure 2. 0 cm from the hub. If the cause cannot be determined, withdraw the device or system as a unit. Figure 1. Do not resterilize or reuse. Use prior to the Use By date. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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). Indigo System Intended Use Indigo Aspiration System Intended Use Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. function gtag(){dataLayer.push(arguments);} 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. Order Qty. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. To prevent fire or shock hazard, use a replacement power cord of equal rating. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 2: Add 0 cm from the distal tip. She had acute tubular necrosis with minimal urine output at the time of transfer. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Additional Details. Copyright 2022 Penumbra, Inc. All rights reserved. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. These types of burns heal withing 5 or 6 days without permanent scarring. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Potential Adverse Events The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. University of Massachusetts Medical School The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . IN-DATE. This website is intended for US audience only. Do not use in an oxygen rich environment. LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. Figure 2. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 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. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Equipment is not safe for MR use. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use in oxygen rich environment. 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. 2015;372:1389-1398. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. Potential Adverse Events Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Use prior to the Use By date. window.dataLayer = window.dataLayer || []; Learn more about Lightning. No modification of this equipment is allowed. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; and Suhail Dohad, MD, FACC. Copyright 2022 Penumbra, Inc. All rights reserved. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Penumbra's high-performance aspiration catheters. Do not use open or damaged packages. The cat8 was kinked approximately 69. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Do not use kinked or damaged devices. Cedars Sinai Medical Center window.dataLayer = window.dataLayer || []; The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. gtag('js', new Date()); For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Prior to use, please consult device labeling and instructions for use. CAT RX is an essential tool in our percutaneous coronary armamentarium. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Copyright 2023 Penumbra, Inc. All rights reserved. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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 patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. BJC Cardiology Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Saint Louis, Missouri Initial angiogram showing high thrombus burden in the left circumflex artery. Figure 1. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. Possible complications include, but are not limited to, the following: Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. INDIGO Aspiration System Indication for Use The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Catheters & Separators. Giri J, Sista AK, Weinberg J, et al. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Indication For Use . Use prior to the Use By date. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. 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. Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. Kingsport, Tennessee Figure 1. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The patient remained on cangrelor with no need for tirofiban. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Brian Kolski, MD Orange, California Contraindications Categories. 5 and 94. There was partial improvement of flow, but total occlusion remained.

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