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. Next Article Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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 . Do not block bottom air vents. This website is intended for US audience only. 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. Return all damaged devices and packaging to the manufacturer/ distributor. 2: Add Worcester, Massachusetts Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Penumbra Aspiration Pump: After one pass with CAT RX, the initial occlusion was removed. Contraindications Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Figure 2. Final angiogram with complete TIMI 3 flow after the use of CAT RX. 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. Bradenton Cardiology Center/Manatee Memorial Hospital With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. The procedure was completed with the same catheter. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. UMassMemorial University Campus CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. J Vasc Interv Radiol. Contraindications Contraindications There are no contraindications. The complaint has been evaluated. The treatment of arterial and venous thrombus is challenging. Kingsport, Tennessee The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. 5 and 94. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . 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. Gus Theodos, MD, FACC, FSCAI Categories. Do not use open or damaged packages. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The penumbra cat8 indigo system (cat8) was kinked approximately 4. 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. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. Figure 2. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Units in stock: 1. 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 LIGHTNING Aspiration Tubing. 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. UPC: Current Stock: . Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Do not use in an oxygen rich environment. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Do not use open or damaged packages. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 0 cm from the distal tip. Ultrasound-guided access was obtained through the right femoral vein. Equipment is not safe for MR use. Waqas R. Qureshi, MD, MS This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. 0, and 37. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Saint Louis, Missouri 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. Smidt Heart institute Figure 3. To prevent fire or shock hazard, use a replacement power cord of equal rating. The procedure can be performed quickly,1 which is important for symptomatic patients. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Saxon RR, Benenati JF, Teigen C, et al. Warnings Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Brian Kolski, MD Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 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: Worcester, Massachusetts 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. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). Do not use kinked or damaged devices. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. If the cause cannot be determined, withdraw the device or system as a unit. CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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. Director, Structural Heart 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 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. Copyright 2022 Penumbra, Inc. All rights reserved. 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. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. INDIGO Aspiration Catheters and Separators: 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). Separator 8, 150 cm Length, 0.072 in. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The pain became more intense and constant, so he presented to the ED. Potential Adverse Events Created with Sketch. 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). 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. Interventional Cardiology Vedantham S, Goldhaber SZ, Julian JA, et al. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Figure 2. The system uses Penumbra's RED reperfusion catheters. Possible complications include, but are not limited to, the following: Return all damaged devices and packaging to the manufacturer/distributor. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The Swan-Ganz catheter was exchanged over a long V18 wire. Mathews SJ, Brown C, Kolski B, et al. Jawairia Sahar K. Mirza, MBBS These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. 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. Jolly SS, Cairns JA, Yusuf S, et al. Warnings/Precautions The canister is intended for single use only. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The CAT family of catheters is the foundation of Penumbra's Indigo System. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Copyright 2023 Penumbra, Inc. All rights reserved. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. 0, 23. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Indication For Use Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. Copyright 2022 Penumbra, Inc. All rights reserved. Use prior to the Use By date. 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. Figure 1. CAT RX has allowed us to rethink how we approach these occluded SVGs. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Copyright 2022 Penumbra, Inc. All rights reserved. J Am Coll Cardiol. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Prior to use, please consult device labeling and instructions for use. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 3. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Maintain a constant infusion of appropriate flush solution. Return all damaged devices and packaging to the manufacturer/distributor. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Penumbra ENGINE Intended Use A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Maintain a constant infusion of appropriate flush solution. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The INDIGO Aspiration Tubing: Final angiographic result of SVG. University of Massachusetts Medical School Do not re-infuse blood or fluid from the canister back into the patient. 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. After IVUS, the stent was dilated to 3.75 mm. 2023 Bryn Mawr Communications II, LLC. Copyright 2023 Penumbra, Inc. All rights reserved. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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 Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The removal of fibrous, adherent or calcified material (e.g. SVG occlusions can be challenging to resolve using traditional treatment modalities. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Otherwise, this could result in degradation of the performance of this equipment. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Penumbra ENGINE Intended Use When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the 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. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 8: Add BMK6F95M-NE . Do not use open or damaged packages. The patient remained on cangrelor with no need for tirofiban. Potential Adverse Events QUICK VIEW. 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. 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. LIGHTNING Aspiration Tubing Indication for Use Aspiration Tubing Intended Use A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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.
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