Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Penumbra Cat 8 - IndiaMART INDIGO Aspiration Tubing: The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The CAT family of catheters is the foundation of Penumbra's Indigo System. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Jolly SS, Cairns JA, Yusuf S, et al. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. 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 . Jawairia Sahar K. Mirza, MBBS Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Figure 1. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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. Indigo System CAT RX | Penumbra Inc These pages are not intended for patients or for members of the general public. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. UMassMemorial University Campus The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm The complaint indicated that the cat8 was kinked during the procedure. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. 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 . Prior to use, please consult device labeling and instructions for use. CAT8XTORQ115KIT-NS. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. The results may vary depending on a variety of patient specific attributes. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality Do not block bottom or back air vents. 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. Precautions The device is intended for single use only. The CAT family of catheters is the foundation of Penumbra's Indigo system. . kolskiwellness@gmail.com If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Warnings/Precautions The canister is intended for single use only. Potential Adverse Events Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Return all damaged devices and packaging to the manufacturer/distributor. This content is not intended to offer professional medical advice. This content is not intended to offer professional medical advice. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Maintain a constant infusion of appropriate flush solution. The means of mains disconnect is to remove the power cord. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Maintain a constant infusion of appropriate flush solution. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. 2015;372:1389-1398. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. The device is intended for single use only. 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. 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 utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. CAT RX is an essential tool in our percutaneous coronary armamentarium. 1. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Do not reuse. QUICK VIEW. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Figure 3. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Penumbra Aspiration Pump: 5 and 94. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Do not resterilize or reuse. Contraindications There are no contraindications. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 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. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Sista A. Indigo aspiration system for acute pulmonary embolism. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Learn more about Lightning. Final angiogram with complete TIMI 3 flow after the use of CAT RX. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. Figure 1. Do not use kinked or damaged devices. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. window.dataLayer = window.dataLayer || []; Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. Units in stock: 1. Aspiration Tubing Intended Use Use prior to the Use By date. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Precautions Mathews SJ, Brown C, Kolski B, et al. 2023 Bryn Mawr Communications II, LLC. The pain became more intense and constant, so he presented to the ED. The Swan-Ganz catheter was exchanged over a long V18 wire. She was in a rehab facility prior to this new event recovering from her CVA. Indication For Use Otherwise, this could result in degradation of the performance of this equipment. Use prior to the Use By date. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. There are no contraindications. The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. TIMI 3 flow was achieved in 88% of cases. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 2018;29:92-100. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Missouri Baptist Medical Center Equipment is not safe for MR use. Brian Kolski, MD Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; hemoptysis; respiratory failure; thromboembolic events. The Indigo Aspiration System is contraindicated in: 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 . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX sjaymathewsmd@gmail.com Categories. Use only waterbased solvents for cleaning. 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. 22. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. 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. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Alameda, CA 94502. 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). Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 2018;72:1589-1596. Mechanical Power Aspiration With the Indigo - Endovascular Today Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Available in a selection of sizes, the CAT family can provide access to distal peripheral . 0 cm from the distal tip. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). gtag('js', new Date()); Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. 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. Cedars Sinai Medical Center The INDIGO Aspiration System 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. Lightning Flash: The Most Powerful and Advanced Mechanical Potential Adverse Events The INDIGO SEPARATOR is not intended for use as a guidewire. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq The removal of fibrous, adherent or calcified material (e.g. Photo: Courtesy of Business Wire. waqas.qureshi@umassmemorial.org 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. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. PENUMBRA: CAT3 - westcmr.com After one pass with CAT RX, the initial occlusion was removed. 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. Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. 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. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Warnings Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. 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. function gtag(){dataLayer.push(arguments);} 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). 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. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Final angiogram after stent placement showing resolution of underlying disease. INDIGO Aspiration Tubing: 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. 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. 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 pulmonary capillary wedge pressure is 10 mmHg. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Return all damaged devices and packaging to the manufacturer/distributor. Copyright 2022 Penumbra, Inc. All rights reserved. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Vascular Thrombectomy. Penumbra ENGINE Intended Use Maintain a constant infusion of appropriate flush solution. This warranted the need for further innovation in the field of acute coronary syndrome.2 The goal of the Indigo System CAT RX mechanical aspiration system powered by the Penumbra ENGINE is to provide sustained aspiration for the duration of the procedure with enhanced deliverability to navigate tortuous anatomy and track to the distal coronary vasculature. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. The device is intended for single use only. window.dataLayer = window.dataLayer || []; The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. 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. 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. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Director of Cardiac Catheterization Lab, PERT & Structural Heart Potential Adverse Events If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. CAT7 and CAT12 are the next generation of the Indigo System catheters. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. N Engl J Med. Do not use in oxygen rich environment. Prior to use, please consult device labeling and instructions for use. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Potential Adverse Events 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.). Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. US physicians publish "first reported use" of Indigo aspiration system This website is intended for US audience only. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. LIGHTNING Aspiration Tubing Indication for Use Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. INDIGO Aspiration System Intended Use 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. The CAT family of catheters is the foundation of Penumbras Indigo System. The INDIGO SEPARATOR is not intended for use as a guidewire. She had acute tubular necrosis with minimal urine output at the time of transfer. 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. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. Contraindications There are no known contraindications. Copyright 2023 Penumbra, Inc. All rights reserved. Do not use open or damaged packages. 1. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Initial angiogram showing high thrombus burden in the left circumflex artery. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion.

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