The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 3. Catheters - Aspiration Catheters - Page 1 - Medical Materials . Aspiration Tubing Intended 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. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. PENUMBRA ENGINE Indication for Use 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. Warnings/Precautions Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. $399.00 EACH. Otherwise, this could result in degradation of the performance of this equipment. 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). . Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Potential Adverse Events The device is intended for single use only. Chris Metzger, MD The pulmonary capillary wedge pressure is 10 mmHg. 1. 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. 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. Return all damaged devices and packaging to the manufacturer/distributor. Precautions The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not re-infuse blood or fluid from the canister back into the patient. Copyright 2023 Penumbra, Inc. All rights reserved. Created with Sketch. 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 Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. N Engl J Med. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The cerebral vasculature Do not use in an oxygen rich environment. Director of Cardiac Catheterization Lab, PERT & Structural Heart Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Figure 1. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq The CAT family of catheters is the foundation of Penumbras Indigo System. 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. Indication For Use function gtag(){dataLayer.push(arguments);} Saxon RR, Benenati JF, Teigen C, et al. Use prior to the Use By date. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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. PENUMBRA: SEP8 - Westcmr.com Figure 2. 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; Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Use only water-based solvents for cleaning. . Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. N Engl J Med. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. Orange, California Control angiography immediately after thrombectomy demonstrated restored patency . Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Do not resterilize or reuse. 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. Randomized trial of primary PCI with or without routine manual thrombectomy. Mathews SJ, Brown C, Kolski B, et al. Interventional Cardiology The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. No modification of this equipment is allowed. The CAT family of catheters is the foundation of Penumbra's Indigo System. 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. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. 0, and 37. Do not use kinked or damaged devices. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The Indigo Aspiration System is contraindicated in: 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. University of Massachusetts Medical School PENUMBRA: CAT6 - WestCMR Circulation. 0, 24. 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. 2018;72:1589-1596. Penumbra Indigo System | Vascular Thrombectomy The means of mains disconnect is to remove the power cord. Equipment is not safe for MR use. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. PDF May 15, 2018 - Food And Drug Administration Flow through left circumflex artery post-CAT RX. 510 (k) Number. Do not use kinked or damaged devices. Worcester, Massachusetts For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 5, 19. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The patient remained on cangrelor with no need for tirofiban. 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. No modification of this equipment is allowed. Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. System Chair, Clinical Research Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. 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. sjaymathewsmd@gmail.com . Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. If the cause cannot be determined, withdraw the device or system as a unit. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Possible complications include, but are not limited to, the following: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 1. Final angiogram with complete TIMI 3 flow after the use of CAT RX. kolskiwellness@gmail.com The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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 . Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX 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. Indigo System | Penumbra Inc The low-profile catheter and Penumbra . 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. 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. UPC: Current Stock: . 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 System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Throughout each case, Lightning provides procedural feedback via audio visual cues. INDIGO Aspiration System Indication for Use The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . There were no cases of 30-day cardiovascular death or post procedural stroke. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. CAT8XTORQ115KIT-NS. Contraindications There are no known contraindications. To prevent fire or shock hazard, use a replacement power cord of equal rating. right-arrow CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 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 System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Learn more about Lightning. 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. 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. suhail.dohad@cshs.org Mechanical Thrombectomy. J Am Coll Cardiol. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Indigo System Intended Use Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing Indication For Use 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. Disclosures: None. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed The system uses Penumbra's RED reperfusion catheters. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. 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. 5 and 94. 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. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). INDIGO Aspiration Catheters and Separators: These types of burns heal withing 5 or 6 days without permanent scarring. Indigo System CAT RX | Penumbra Inc gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Initial angiogram of the right pulmonary artery showing pulmonary embolism. UMassMemorial University Campus J Vasc Interv Radiol. 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 kinked or damaged devices. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Jolly SS, Cairns JA, Yusuf S, et al. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Figure 2. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Potential Adverse Events Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. Return all damaged devices and packaging to the manufacturer/distributor. chronic clot, atherosclerotic plaque) 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. 3. The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight 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. 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 minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. 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. Created with Sketch. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Figure 1. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. 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. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. waqas.qureshi@umassmemorial.org Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Do not block bottom or back air vents. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbra ENGINE Indication For Use This content is not intended to offer professional medical advice. 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). 2: Add 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. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 5, 21. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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 introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . She had acute tubular necrosis with minimal urine output at the time of transfer. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). 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. Contraindications Not for use in the coronaries or the neurovasculature. 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. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 0 cm from the distal tip. 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 . Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Figure 1. 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. Lightning Flash: The Most Powerful and Advanced Mechanical

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