Penumbra ENGINE Intended Use Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. INDIGO Aspiration Tubing: Director of Cardiac & Peripheral Cath Lab Bradenton Cardiology Center/Manatee Memorial Hospital Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. The treatment of arterial and venous thrombus is challenging. Distal emboli causing PDA occlusion after manual aspiration. Prior to use, please consult device labeling and instructions for use. 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. Director of Cardiac Catheterization Lab, PERT & Structural Heart Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Tareq Kass-Hout. Otherwise, this could result in degradation of the performance of this equipment. INDIGO System LIGHTNING Aspiration Tubing Intended Use Do not use open or damaged packages. 1. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. 5, 21. Do not use kinked or damaged devices. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Initial angiogram showing high thrombus burden in the RCA. Warnings/Precautions kolskiwellness@gmail.com Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Do not use kinked or damaged devices. Maintain a constant infusion of appropriate flush solution. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The pain became more intense and constant, so he presented to the ED. Use prior to the Use By date. 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. Possible complications include, but are not limited to, the following: Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Do not resterilize or reuse. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Return all damaged devices and packaging to the manufacturer/distributor. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The procedure can be performed quickly,1 which is important for symptomatic patients. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. gus.theodos@bjc.org; @gtheodosmd No modification of this equipment is allowed. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Missouri Baptist Medical Center 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Ballad CVA Heart & Vascular Institute When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. Potential Adverse Events Do not use open or damaged packages. 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. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . CAT RX is an essential tool in our percutaneous coronary armamentarium. 8: Add BMK6F95M-NE . Further evaluation of the returned device revealed kinks in the catheter shaft. Prior to use, please consult device labeling and instructions for use. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Related Items. 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. The pulmonary capillary wedge pressure is 10 mmHg. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. 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 in an oxygen rich environment. Distal posterior tibial artery emboli occlusion. function gtag(){dataLayer.push(arguments);} 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 Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. This press release features multimedia. Orange, California The complaint has been evaluated. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Giri J, Sista AK, Weinberg J, et al. Maintain a constant infusion of appropriate flush solution. 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. Indication For Use The CAT family of catheters is the foundation of Penumbra's Indigo System. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Disclosures: None. Mathews SJ, Brown C, Kolski B, et al. There are no contraindications. Contraindications Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Aspiration Tubing Intended Use 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. 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. Potential Adverse Events function gtag(){dataLayer.push(arguments);} Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Director, Structural Heart A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Do not block bottom air vents. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Precautions The device is intended or single use only. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . 5 and 94. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Saxon RR, Benenati JF, Teigen C, et al. It will reduce the service life of the PENUMBRA ENGINE. Return all damaged devices and packaging to the manufacturer/distributor. Otherwise, this could result in degradation of the performance of this equipment. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Copyright 2022 Penumbra, Inc. All rights reserved. Indigo Aspiration System Intended Use 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. 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. This is potentially more effective than diminished syringe-based aspiration. 3. 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. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. Worcester, Massachusetts Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Contraindications Not for use in the coronaries or the neurovasculature. 2015;372:1389-1398. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. 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. It will reduce service life of the Penumbra ENGINE. 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. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Precautions 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 . Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. No conversations found. Separator 8, 150 cm Length, 0.072 in. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems 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. Additional Details. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. The means of mains disconnect is to remove the power cord. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . 0 cm from the distal tip. 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. 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 . Figure 2. The Indigo System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. 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. The canister is intended for single use only. Latest System Designed for Single Session Arterial Thrombus Removal News 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. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. 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. 5, 19. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. To prevent fire or shock hazard, use a replacement power cord of equal rating. Warnings Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Maintain a constant infusion of appropriate flush solution. The procedure was completed with the same catheter. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Copyright 2023 Penumbra, Inc. All rights reserved. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. 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. 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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. 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 some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Randomized trial of primary PCI with or without routine manual thrombectomy. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. Smidt Heart institute The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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). 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. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. 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. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Do not resterilize or reuse. Otherwise, this could result in degradation of the performance of this equipment. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. PENUMBRA ENGINE Intended Use Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Figure 2. Indication For Use 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 . She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Mathews SJ, Brown C, Kolski B, et al. After one pass with CAT RX, the initial occlusion was removed. If the cause cannot be determined, withdraw the device or system as a unit. Sista A. Indigo aspiration system for acute pulmonary embolism. gtag('js', new Date()); Gus Theodos, MD, FACC, FSCAI 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. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. This website is intended for US audience only. 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 directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Contraindications The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Return all damaged devices and packaging to the manufacturer/distributor. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Flow through left circumflex artery post-CAT RX. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Penumbra Aspiration Pump: The system uses Penumbra's RED reperfusion catheters. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Contraindications There are no known contraindications. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. The penumbra cat8 indigo system (cat8) was kinked approximately 4.