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 device is intended for single use only. CAT RX is an essential tool in our percutaneous coronary armamentarium. 2015;372:1389-1398. Do not use open or damaged packages. K180412. 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). Only use replacement fuse with correct rating (see Table 1 for fuse rating). Use prior to the Use By date. 2017;377:2240-2252. 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. 0, and 37. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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. Do not reuse. 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. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. . Disclosures: None. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . 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. The product-specific content of this website is intended for use by healthcare professionals only. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). The penumbra cat8 indigo system (cat8) was kinked approximately 4. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Initial angiography revealed an occlusion of the distal RCA. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. minimalism: a documentary about the important things transcript; cat8 penumbra catheter; i 75 road construction cincinnati; tocaya west hollywood; best places to live in alabama near the. Copyright 2023 Penumbra, Inc. All rights reserved. Potential Adverse Events Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. This website is intended for US audience only. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Director, Structural Heart A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. Do not re-infuse blood or fluid from the canister back into the patient. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. There were no cases of 30-day cardiovascular death or post procedural stroke. . 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. 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. 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. The treatment of arterial and venous thrombus is challenging. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Final angiogram showing resolution of extensive thrombus burden. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Potential Adverse Events left-arrow The CAT8 is indicated for removal of emboli and thrombi from the peripheral . She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Director of Cardiac Catheterization Lab, PERT & Structural Heart Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Catheters & Separators. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . 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. Figure 2. Do not resterilize or reuse. Otherwise, this could result in degradation of the performance of this equipment. Units in stock: 1. CAT7 and CAT12 are the next generation of the Indigo System catheters. 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 . It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Use prior to the Use By date. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Precautions The device is intended for single use only. Indigo System CAT RX tracking through the distal posterior tibial artery. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Photo: Courtesy of Business Wire. TIMI 3 flow was achieved in 88% of cases. Flow through left circumflex artery post-CAT RX. Mathews SJ, Brown C, Kolski B, et al. Randomized trial of primary PCI with or without routine manual thrombectomy. 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. Figure 1. 2019;140:e774-e801. After one pass with CAT RX, the initial occlusion was removed. Use prior to the Use By date. J Vasc Interv Radiol. Maintain a constant infusion of appropriate flush solution. Potential Adverse Events 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. Contraindications There are no contraindications. INDIGO System LIGHTNING Aspiration Tubing Intended Use 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. Indigo Aspiration System Intended Use The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Warnings SVG occlusions can be challenging to resolve using traditional treatment modalities. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. If the cause cannot be determined, withdraw the device or system as a unit. Conclusions: evaluation of the cat8 revealed that the device was fractured. She was in a rehab facility prior to this new event recovering from her CVA. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. The CAT family of catheters is the foundation of Penumbra's Indigo System. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. 1. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. If the cause cannot be determined, withdraw the device or system as a unit. 2018;29:92-100. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Brian Kolski, MD Return all damaged devices and packaging to the manufacturer/distributor. 0 cm from the hub. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. 5 and 94. function gtag(){dataLayer.push(arguments);} Jolly SS, Cairns JA, Lavi S, et al. The procedure was completed with the same catheter. 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. 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. The INDIGO SEPARATOR is not intended for use as a guidewire. Created with Sketch. It will reduce service life of the Penumbra ENGINE. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . gtag('js', new Date()); $399.00 EACH. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Warnings These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. The patient remained on cangrelor with no need for tirofiban. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Contraindications There are no known contraindications. Maintain a constant infusion of appropriate flush solution. Use only water-based solvents for cleaning. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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. Order Qty. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. System Chair, Clinical Research These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Penumbra Aspiration Pump: CAT RX has allowed us to rethink how we approach these occluded SVGs. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Ballad CVA Heart & Vascular Institute 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 . window.dataLayer = window.dataLayer || []; Figure 1. 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. 2. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). After IVUS, the stent was dilated to 3.75 mm. 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. Precautions Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Suhail Dohad, MD, FACC Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. N Engl J Med. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Sista A. Indigo aspiration system for acute pulmonary embolism. No modification of this equipment is allowed. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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 canister is intended for single use only. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. The cerebral vasculature 0, 24. The device is intended for single use only. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Los Angeles, California 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. Contraindications 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. 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. 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. Precautions Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Otherwise, this could result in degradation of the performance of this equipment. Use prior to the Use By date. suhail.dohad@cshs.org excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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. Potential Adverse Events Initial angiogram of the right pulmonary artery showing pulmonary embolism. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). window.dataLayer = window.dataLayer || []; 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. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. CAT8XTORQ115KIT-NS. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Prior to use, please consult device labeling and instructions for use. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Return all damaged devices and packaging to the manufacturer/distributor. The product-specific content of this website is intended for use by healthcare professionals only. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Next Article For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Use prior to the Use By date. The Swan-Ganz catheter was exchanged over a long V18 wire. Categories. 22. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Do not use in an oxygen rich environment. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Potential Adverse Events Throughout each case, Lightning provides procedural feedback via audiovisual cues. INDIGO Aspiration System Intended Use In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Copyright 2023 Penumbra, Inc. All rights reserved. Prior to use, please consult device labeling and instructions for use. 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. The removal of fibrous, adherent or calcified material (e.g. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. These pages are not intended for patients or for members of the general public. Return all damaged devices and packaging to the manufacturer/distributor. The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use kinked or damaged devices. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Penumbra's not relying on software alone. The means of mains disconnect is to remove the power cord. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. The Indigo System utilises the Penumbra ENGINE aspiration 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.