Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. . function gtag(){dataLayer.push(arguments);} Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. 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. 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. 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. 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). Conclusions: evaluation of the cat8 revealed that the device was fractured. 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. 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. 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Director, Structural Heart
The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Return all damaged devices and packaging to the manufacturer/ distributor. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Prior to use, please consult device labeling and instructions for use. If the cause cannot be determined, withdraw the device or system as a unit. 1. There were no cases of 30-day cardiovascular death or post procedural stroke. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. window.dataLayer = window.dataLayer || []; Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. 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. IN-DATE. Saxon RR, Benenati JF, Teigen C, et al. Applicant. Disclosures: None. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Distal posterior tibial artery emboli occlusion. Final angiogram after stent placement showing resolution of underlying disease. The device is intended for single use only. The cerebral vasculature Further evaluation of the returned device revealed kinks in the catheter shaft. 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. UMassMemorial University Campus
This content is not intended to offer professional medical advice. This website is intended for US audience only. N Engl J Med. Do not resterilize or reuse. Possible complications include, but are not limited to, the following: 2023 Bryn Mawr Communications II, LLC. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. 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. chronic clot, atherosclerotic plaque) Figure 1. Waqas R. Qureshi, MD, MS
The INDIGO SEPARATOR is not intended for use as a guidewire. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Final angiographic result of SVG. 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. 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. Ballad CVA Heart & Vascular Institute
Suhail Dohad, MD, FACC
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. Distal OD. 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. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. gtag('js', new Date()); The cat8 was kinked approximately 69. The pain became more intense and constant, so he presented to the ED. Contraindications We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 0, and 37. Precautions The device is intended for single use only. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 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. 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. Use prior to the Use By date. window.dataLayer = window.dataLayer || []; Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter 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 . 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. There was partial improvement of flow, but total occlusion remained. 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. If the cause cannot be determined, withdraw the device or system as a unit. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 0 cm from the distal tip. Mathews SJ, Brown C, Kolski B, et al. 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. Jolly SS, Cairns JA, Lavi S, et al. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Worcester, Massachusetts
function gtag(){dataLayer.push(arguments);} 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. Contraindications Not for use in the coronaries or the neurovasculature. 8: Add BMK6F95M-NE . In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Precautions 3. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Interventional Cardiology
The means of mains disconnect is to remove the power cord. 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 procedure can be performed quickly,1 which is important for symptomatic patients. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. The CAT family of catheters is the foundation of Penumbra's Indigo system. Do not re-infuse blood or fluid from the canister back into the patient. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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 . Control angiography immediately after thrombectomy demonstrated restored patency . After one pass with CAT RX, the initial occlusion was removed. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. This content is not intended to offer professional medical advice. Indigo Aspiration System Intended Use The CAT8 is indicated for removal of emboli and thrombi from the peripheral . The complaint indicated that the cat8 was kinked during the procedure. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. INDIGO Aspiration System Intended Use The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Sista A. Indigo aspiration system for acute pulmonary embolism. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Prior to use, please consult device labeling and instructions for use. The procedure was completed with the same catheter. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. It will reduce service life of the Penumbra ENGINE. The system uses Penumbra's RED reperfusion catheters. Photo: Courtesy of Business Wire. 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 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. 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). Maintain a constant infusion of appropriate flush solution. Kingsport, Tennessee
Penumbra Aspiration Pump: Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. $399.00 EACH. Mathews SJ, Brown C, Kolski B, et al. right-arrow Figure 2. Saint Louis, Missouri
These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Use prior to the Use By date. CAT RX is an essential tool in our percutaneous coronary armamentarium. Brian Kolski, MD
Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Flow through left circumflex artery post-CAT RX. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. 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. Director of Cardiac Catheterization Lab, PERT & Structural Heart
Indication For Use Do not use kinked or damaged devices. 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. It will reduce the service life of the PENUMBRA ENGINE. Additional Details. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
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