For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. J Vasc Interv Radiol. 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. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. Equipment is not safe for MR use. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. 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 . Do not re-infuse blood or fluid from the canister back into the patient. 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. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. window.dataLayer = window.dataLayer || []; Indigo System Catheters & Separators | Penumbra Inc Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. CAT8XTORQ115KIT-NS. After one pass with CAT RX, the initial occlusion was removed. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. She had acute tubular necrosis with minimal urine output at the time of transfer. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Sista A. Indigo aspiration system for acute 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. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. SVG occlusions can be challenging to resolve using traditional treatment modalities. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. 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 the PENUMBRA ENGINE. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. PENUMBRA: CAT6 - WestCMR 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 . 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. Ballad CVA Heart & Vascular Institute A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Additional Details. Maintain a constant infusion of appropriate flush solution. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Mathews SJ, Brown C, Kolski B, et al. The means of mains disconnect is to remove the power cord. Copyright 2023 Penumbra, Inc. All rights reserved. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Units in stock: 1. 2023 Bryn Mawr Communications II, LLC. 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. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Disclosures: None. Catheters - Aspiration Catheters - Page 1 - Medical Materials Do not use kinked or damaged devices. The Swan-Ganz catheter was exchanged over a long V18 wire. 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. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Medical Director, Aortic Disease and Ischemic Limb Disease Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Jolly SS, Cairns JA, Lavi S, et al. Suhail Dohad, MD, FACC PENUMBRA ENGINE Indication for Use The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Do not use open or damaged packages. left-arrow 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. K180412. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. 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 advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Do not resterilize or reuse. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Precautions 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. Potential Adverse Events The device is intended for single use only. 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 Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The product-specific content of this website is intended for use by healthcare professionals only. Contraindications There are no known contraindications. LIGHTNING Aspiration Tubing Indication for Use Initial angiogram showing high thrombus burden in the left circumflex artery. Possible complications include, but are not limited to, the following: The penumbra cat8 indigo system (cat8) was kinked approximately 4. Penumbra ENGINE Intended Use Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 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; Prior to use, please consult device labeling and instructions for use. PDF May 15, 2018 - Food And Drug Administration INDIGO Aspiration System Intended Use 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. Contraindications There are no known contraindications. 1. Use prior to the Use By date. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The product-specific content of this website is intended for use by healthcare professionals only. Figure 3. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. To prevent fire or shock hazard, use a replacement power cord of equal rating. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. No modification of this equipment is allowed. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. function gtag(){dataLayer.push(arguments);} 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 product-specific content of this website is intended for use by healthcare professionals only. Otherwise, this could result in degradation of the performance of this equipment. Disclosures: None. Lightning comes packaged with the Indigo CAT7 or CAT12. PENUMBRA ENGINE Intended Use Figure 2. Catheters & Separators. 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: An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . sjaymathewsmd@gmail.com 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. Indigo Aspiration System Intended Use If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (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. 3. 1. Conclusions: evaluation of the cat8 revealed that the device was fractured. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Initial angiogram showing high thrombus burden in the RCA. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. (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. 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. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. function gtag(){dataLayer.push(arguments);} Otherwise, this could result in degradation of the performance of this equipment. Equipment is not safe for MR use. 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; and Suhail Dohad, MD, FACC. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Aspiration Tubing Intended Use The CAT family of catheters is the foundation of Penumbra's Indigo System. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The Indigo System and CAT8 - Endovascular Today Jolly SS, Cairns JA, Yusuf S, et al. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. 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. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. Precautions Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Use prior to the Use By date. The INDIGO Aspiration Tubing: If the cause cannot be determined, withdraw the device or system as a unit. The patient remained on cangrelor with no need for tirofiban. This content is not intended to offer professional medical advice. 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. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Figure 2. 1. Do not use in an oxygen rich environment. Circulation. Copyright 2022 Penumbra, Inc. All rights reserved. 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. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Latest System Designed for Single Session Arterial Thrombus Removal News The complaint indicated that the cat8 was kinked during the procedure. Return all damaged devices and packaging to the manufacturer/distributor. Learn more about Lightning. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. Penumbra System Products - Medical Materials 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not re-infuse blood or fluid from the canister back into the patient. Maintain a constant infusion of appropriate flush solution. The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery.