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. Learn more about Lightning. Separator 8, 150 cm Length, 0.072 in. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Figure 2. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Possible complications include, but are not limited to, the following: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Otherwise, this could result in degradation of the performance of this equipment. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Kingsport, Tennessee
Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). 2019;140:e774-e801. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Orange, California
5 and 94. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. $399.00 EACH. Figure 3. Lightning comes packaged with the Indigo CAT7 or CAT12. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Do not use in an oxygen rich environment. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Use prior to the Use By date. 0, 23. 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. right-arrow 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. Do not use open or damaged packages. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. 3. Ballad CVA Heart & Vascular Institute
CAT7 and CAT12 are the next generation of the Indigo System catheters. The INDIGO SEPARATOR is not intended for use as a guidewire. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. 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. 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 . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. J Am Coll Cardiol. 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 . 0, 26. Gus Theodos, MD, FACC, FSCAI
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. 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; 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). Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. 2017;377:2240-2252. 2018;29:92-100. No conversations found. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. 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. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. function gtag(){dataLayer.push(arguments);} The device is intended for single use only. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. 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 deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. INDIGO Aspiration System Indication for Use 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. If the cause cannot be determined, withdraw the device or system as a unit. Initial angiogram showing high thrombus burden in the RCA. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Indication For Use This is potentially more effective than diminished syringe-based aspiration. 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. Jolly SS, Cairns JA, Lavi S, et al. Bradenton Cardiology Center/Manatee Memorial Hospital
Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Figure 3. These pages are not intended for patients or for members of the general public. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Distal OD. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Use prior to the Use By date. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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 . The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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 . Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. . 1. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use 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. 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. Do not use in oxygen rich environment. Warnings System Chair, Clinical Research
The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Return all damaged devices and packaging to the manufacturer/ distributor. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. The system uses Penumbra's RED reperfusion catheters. 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. 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. If the cause cannot be determined, withdraw the device or system as a unit. 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. Do not use open or damaged packages. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. This is potentially more effective than diminished syringe-based aspiration. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Potential Adverse Events Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. 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.