Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. suhail.dohad@cshs.org Ballad CVA Heart & Vascular Institute The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Do not use open or damaged packages. Copyright 2023 Penumbra, Inc. All rights reserved. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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 CAT family of catheters is the foundation of Penumbra's Indigo System. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 0 cm from the hub. Tareq Kass-Hout. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. INDIGO Aspiration System Intended Use Suhail Dohad, MD, FACC 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. 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. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. 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 final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Photo: Courtesy of Business Wire. The pain became more intense and constant, so he presented to the ED. Contraindications There are no contraindications. Otherwise, this could result in degradation of the performance of this equipment. 1. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. . The INDIGO SEPARATOR is not intended for use as a guidewire. function gtag(){dataLayer.push(arguments);} The Indigo Aspiration System is contraindicated in: If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. Final angiogram showing resolution of extensive thrombus burden. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Created with Sketch. 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. 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. The procedure can be performed quickly,1 which is important for symptomatic patients. 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: Penumbra Aspiration Pump: Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 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. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. The canister is intended for single use only. 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 Computer-Aided Aspiration comes packaged with CAT7 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'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. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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). Do not resterilize or reuse. Categories. 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. Possible complications include, but are not limited to, the following: This content is not intended to offer professional medical advice. Do not use kinked or damaged devices. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Otherwise, this could result in degradation of the performance of this equipment. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. 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 product-specific content of this website is intended for use by healthcare professionals only. Device Name. Copyright 2023 Penumbra, Inc. All rights reserved. window.dataLayer = window.dataLayer || []; Catheters & Separators. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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. 2015;372:1389-1398. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Kingsport, Tennessee Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . University of Massachusetts Medical School We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Penumbra, Inc. One Penumbra Place. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use prior to the Use By date. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Precautions 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. gtag('js', new Date()); The low-profile catheter and Penumbra ENGINE are easy to set up and use. Do not use in oxygen rich environment. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Indication For Use 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. Do not resterilize or reuse. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Use only water-based solvents for cleaning. Prior to use, please consult device labeling and instructions for use. This press release features multimedia. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 1. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Mathews SJ, Brown C, Kolski B, et al. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 0 cm from the distal tip. No modification of this equipment is allowed. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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). gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Maintain a constant infusion of appropriate flush solution. 5, 21. Contraindications Indigo System | Computer-Aided Mechanical Aspiration. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. INDIGO Aspiration System Indication for Use Control angiography immediately after thrombectomy demonstrated restored patency . The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Learn more about Lightning. 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. UPC: Current Stock: . Otherwise, this could result in degradation of the performance of this equipment. Applicant. Figure 3. Orange, California Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Figure 2. 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. 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 CAT family of catheters is the foundation of Penumbra's Indigo system. 0, 23. Flow through left circumflex artery post-CAT RX. Jawairia Sahar K. Mirza, MBBS Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Separator 8, 150 cm Length, 0.072 in. To prevent fire or shock hazard, use a replacement power cord of equal rating. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. 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. 3. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI.