left-arrow 1. 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). The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Figure 3. Figure 2. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Jolly SS, Cairns JA, Lavi S, et al. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. The penumbra cat8 indigo system (cat8) was kinked approximately 4. 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. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The low-profile catheter and Penumbra . 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. 2018;29:92-100. Penumbra's high-performance aspiration catheters. Potential Adverse 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; 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. 22. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Maintain a constant infusion of appropriate flush solution. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Copyright 2023 Penumbra, Inc. All rights reserved. Warnings 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). Conclusions: evaluation of the cat8 revealed that the device was fractured. J Am Coll Cardiol. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 5 and 94. Circulation. 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. 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. Initial angiography revealed an occlusion of the distal RCA. 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. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Alameda, CA 94502. function gtag(){dataLayer.push(arguments);} Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. These pages are not intended for patients or for members of the general public. suhail.dohad@cshs.org Disclosures: None. Jolly SS, Cairns JA, Yusuf S, et al. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. No modification of this equipment is allowed. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Figure 2. These pages are not intended for patients or for members of the general public. Created with Sketch. 0, 23. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 1. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Potential Adverse Events Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. window.dataLayer = window.dataLayer || []; The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Figure 2. Warnings/Precautions The canister is intended for single use only. INDIGO Aspiration Tubing: 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. Penumbra Aspiration Pump: Otherwise, this could result in degradation of the performance of this equipment. 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 patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. Do not use in an oxygen rich environment. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. gtag('js', new Date()); The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Randomized trial of primary PCI with or without routine manual thrombectomy. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Precautions Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. CAT7 and CAT12 are the next generation of the Indigo System catheters. 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. Equipment is not safe for MR use. N Engl J Med. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. function gtag(){dataLayer.push(arguments);} CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 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. Saxon RR, Benenati JF, Teigen C, et al. Otherwise, this could result in degradation of the performance of this equipment. Potential Adverse Events As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Medical Director, Aortic Disease and Ischemic Limb Disease Contraindications There are no known contraindications. 0, 26. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Final angiographic result of SVG. 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 . Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Figure 3. Contraindications Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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 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. 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. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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. Distal posterior tibial artery emboli occlusion. Precautions The device is intended or single use only. Copyright 2022 Penumbra, Inc. All rights reserved. The CAT family of catheters is the foundation of Penumbras Indigo System. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Indigo Aspiration System Intended Use 3. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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). Do not use in an oxygen rich environment. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. The device is intended for single use only. Ballad CVA Heart & Vascular Institute 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). 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. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Further evaluation of the returned device revealed kinks in the catheter shaft. 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 kinked or damaged devices. 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. No conversations found. 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. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. 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 CAT family of catheters is the foundation of Penumbra's Indigo System. 8: Add BMK6F95M-NE . Indication For Use INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for 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.
cat8 penumbra catheter
