Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. St. Joseph Hospital J Am Coll Cardiol. Medical Director, Aortic Disease and Ischemic Limb Disease $399.00 EACH. 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. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. This is potentially more effective than diminished syringe-based aspiration. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Alameda, CA 94502. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. 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. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Ultrasound-guided access was obtained through the right femoral vein. 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. 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 . Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Use only water-based solvents for cleaning. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. 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. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. This content is not intended to offer professional medical advice. Maintain a constant infusion of appropriate flush solution. Control angiography immediately after thrombectomy demonstrated restored patency . Warnings Figure 1. The device is intended for single use only. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Prior to use, please consult device labeling and instructions for use. 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). Kingsport, Tennessee Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Distal OD. Do not use kinked or damaged devices. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. 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. 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. 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 . Penumbra's not relying on software alone. 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 In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Indication For Use 2. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. INDIGO Aspiration System Intended Use Copyright 2023 Penumbra, Inc. All rights reserved. Do not use open or damaged packages. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. 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. J Vasc Interv Radiol. 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. Contraindications There are no known contraindications. Potential Adverse Events PENUMBRA: SEP8 - Westcmr.com Aspiration Tubing Intended Use Penumbra System Products - Medical Materials Return all damaged devices and packaging to the manufacturer/distributor. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. 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. 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). SVG occlusions can be challenging to resolve using traditional treatment modalities. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. . Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Precautions The device is intended for single use only. gus.theodos@bjc.org; @gtheodosmd She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Do not use in oxygen rich environment. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Figure 2. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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 complaint has been evaluated. The pain became more intense and constant, so he presented to the ED. Next Article The low-profile catheter and Penumbra . QUICK VIEW. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. CAT7 and CAT12 are the next generation of the Indigo System catheters. Contraindications Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Los Angeles, California The means of mains disconnect is to remove the power cord. window.dataLayer = window.dataLayer || []; The CAT8 is indicated for removal of emboli and thrombi from the peripheral . 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. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . 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. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Bradenton Cardiology Center/Manatee Memorial Hospital Mathews SJ, Brown C, Kolski B, et al. Created with Sketch. Order Qty. These pages are not intended for patients or for members of the general public. Penumbra ENGINE Intended Use Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Figure 1. 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. Figure 2. BJC Cardiology Created with Sketch. Penumbra Indigo System | Vascular Thrombectomy 2023 Bryn Mawr Communications II, LLC. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. A, Penumbra Indigo System Continuous Aspiration - ResearchGate Do not resterilize or reuse. Rethinking Thrombus Removal With the Indigo System: Introducing Categories. Do not reuse. Equipment is not safe for MR use. Indigo Aspiration System Intended Use CAT RX has allowed us to rethink how we approach these occluded SVGs. 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. It will reduce the service life of the PENUMBRA ENGINE. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Precautions The device is intended for single use only. (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. PENUMBRA ENGINE Indication for Use The procedure can be performed quickly,1 which is important for symptomatic patients. 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. PENUMBRA: CAT3 - westcmr.com The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Brian Kolski, MD 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 enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: These pages are not intended for patients or for members of the general public. The low-profile catheter and Penumbra ENGINE are easy to set up and 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 . INDIGO Aspiration System Indication for Use 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 presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. 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 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. Return all damaged devices and packaging to the manufacturer/ distributor. To prevent fire or shock hazard, use a replacement power cord of equal rating. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Indigo System - Vascupedia Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. 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. Indigo System | Penumbra Inc When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Copyright 2022 Penumbra, Inc. All rights reserved. Copyright 2022 Penumbra, Inc. All rights reserved. waqas.qureshi@umassmemorial.org Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. The CAT familyof catheters is the foundation of Penumbras Indigo System. Do not use open or damaged packages. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. After IVUS, the stent was dilated to 3.75 mm. Units in stock: 1. Do not re-infuse blood or fluid from the canister back into the patient. 8: Add BMK6F95M-NE . Only use replacement fuse with correct rating (see Table 1 for fuse rating). Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The Indigo System and CAT8 - Endovascular Today Contraindications There are no contraindications. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Maintain a constant infusion of appropriate flush solution. The means of mains disconnect is to remove the power cord. . 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. UPC: Current Stock: . Penumbra Augments Vascular Franchise with Latest Indigo System Launch Figure 3. Initial angiogram of the right pulmonary artery showing pulmonary embolism. 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. Copyright 2023 Penumbra, Inc. All rights reserved. LIGHTNING Aspiration Tubing Indication for Use Do not use in an oxygen rich environment. Do not use kinked or damaged devices. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Return all damaged devices and packaging to the manufacturer/distributor. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not reuse. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. 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). Mechanical thrombectomy was performed. US physicians publish "first reported use" of Indigo aspiration system Catheters - Aspiration Catheters - Page 1 - Medical Materials When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. 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. Contraindications Not for use in the coronaries or the neurovasculature. This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems.