Figure 3. window.dataLayer = window.dataLayer || []; This site is protected by reCAPTCHA and the Google, 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 Intelligent Aspiration comes packaged with CAT7, CAT8 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 Indigo SystemCAT3, 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 Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 2019;140:e774-e801. Order Qty. Do not use in an oxygen rich environment. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The CAT familyof catheters is the foundation of Penumbras Indigo System. Do not resterilize or reuse. 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. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Initial angiography revealed an occlusion of the distal RCA. Learn more about Lightning. K180412. INDIGO Aspiration Tubing: 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. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. 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). A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Do not use open or damaged packages. 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. 22. 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. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. gtag('js', new Date()); Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. She was in a rehab facility prior to this new event recovering from her CVA. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 5 and 94. 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. These pages are not intended for patients or for members of the general public. 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. Copyright 2022 Penumbra, Inc. All rights reserved. Applicant. Worcester, Massachusetts INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for 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. Disclosures: None. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Jolly SS, Cairns JA, Lavi S, et al. 5, 19. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Figure 2. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Figure 1. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Units in stock: 1. Copyright 2023 Penumbra, Inc. All rights reserved. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. 3. 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. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. 2018;29:92-100. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Figure 1. function gtag(){dataLayer.push(arguments);} Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). To prevent fire or shock hazard, use a replacement power cord of equal rating. Use only waterbased solvents for cleaning. The procedure was completed with the same catheter. 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. Figure 2. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. These pages are not intended for patients or for members of the general public. Tareq Kass-Hout. No modification of this equipment is allowed. 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 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. Equipment is not safe for MR use. 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. 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. The device is intended for single use only. Cedars Sinai Medical Center Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. 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. Conclusions: evaluation of the cat8 revealed that the device was fractured. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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. 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 product-specific content of this website is intended for use by healthcare professionals only. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Ballad CVA Heart & Vascular Institute Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Distal emboli causing PDA occlusion after manual aspiration. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Control angiography immediately after thrombectomy demonstrated restored patency . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. J Am Coll Cardiol. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The treatment of arterial and venous thrombus is challenging. 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. BJC Cardiology Possible complications include, but are not limited to, the following: Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Do not resterilize or reuse. Contraindications Potential Adverse Events 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. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Return all damaged devices and packaging to the manufacturer/distributor. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Distal posterior tibial artery emboli occlusion. 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. 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 initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Mathews SJ, Brown C, Kolski B, et al. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Copyright 2022 Penumbra, Inc. All rights reserved. Enter your email address and we will contact you. 0, 23. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 INDIGO Aspiration System Intended Use Do not block bottom air vents. 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. Indigo System Intended Use A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Warnings waqas.qureshi@umassmemorial.org 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. The low-profile catheter and Penumbra . window.dataLayer = window.dataLayer || []; The results may vary depending on a variety of patient specific attributes. Figure 2. The pulmonary capillary wedge pressure is 10 mmHg. No conversations found. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Initial angiogram showing high thrombus burden in the left circumflex artery. After IVUS, the stent was dilated to 3.75 mm. The removal of fibrous, adherent or calcified material (e.g. The pain became more intense and constant, so he presented to the ED. Return all damaged devices and packaging to the manufacturer/distributor. Missouri Baptist Medical Center Figure 3. 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. Otherwise, this could result in degradation of the performance of this equipment. The system uses Penumbra's RED reperfusion catheters. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Maintain a constant infusion of appropriate flush solution. Waqas R. Qureshi, MD, MS 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. Director, Structural Heart Circulation. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. 3. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . It will reduce service life of the Penumbra ENGINE. 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. Do not use open or damaged packages. 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. These types of burns heal withing 5 or 6 days without permanent scarring. Potential Adverse Events . CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Photo: Courtesy of Business Wire. Brian Kolski, MD Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. gus.theodos@bjc.org; @gtheodosmd LIGHTNING Aspiration Tubing Indication for Use Vedantham S, Goldhaber SZ, Julian JA, et al. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Device Name. No modification of this equipment is allowed. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. SVG occlusions can be challenging to resolve using traditional treatment modalities. Kingsport, Tennessee PENUMBRA ENGINE Indication for Use 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. The cerebral vasculature Vascular Thrombectomy. 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. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Precautions The device is intended or single use only. 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. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. If the cause cannot be determined, withdraw the device or system as a unit. The complaint indicated that the cat8 was kinked during the procedure. 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. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. 2015;372:1389-1398. 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. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. 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). Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Initial angiogram showing high thrombus burden in the RCA. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Indigo Aspiration System Intended Use Medical Director, Aortic Disease and Ischemic Limb Disease 0 cm from the hub. Precautions 8: Add BMK6F95M-NE . Use prior to the Use By date. Maintain a constant infusion of appropriate flush solution. 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. J Vasc Interv Radiol. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Ultrasound-guided access was obtained through the right femoral vein. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Contraindications There are no known contraindications. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Final angiographic result of SVG. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography.
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