In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. Figure 1. Penumbra's high-performance aspiration catheters. 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. 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 ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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 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. Do not use in an oxygen rich environment. 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 . Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Possible complications include, but are not limited to, the following: Penumbra's not relying on software alone. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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. Penumbra System Products - Medical Materials 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. 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. Do not resterilize or reuse. INDIGO Aspiration Tubing: Do not resterilize or reuse. 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. If the cause cannot be determined, withdraw the device or system as a unit. 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. Warnings/Precautions 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. Use prior to the Use By date. The means of mains disconnect is to remove the power cord. Otherwise, this could result in degradation of the performance of this equipment. This is potentially more effective than diminished syringe-based aspiration. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Precautions Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. N Engl J Med. Maintain a constant infusion of appropriate flush solution. The procedure was completed with the same catheter. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. INDIGO System LIGHTNING Aspiration Tubing Intended Use 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 use kinked or damaged devices. Created with Sketch. Categories. Warnings Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary 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. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Use prior to the Use By date. Do not re-infuse blood or fluid from the canister back into the patient. 0 cm from the distal tip. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. System Chair, Clinical Research If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 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. Los Angeles, California 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. Mechanical Thrombectomy. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Do not re-infuse blood or fluid from the canister back into the patient. Figure 2. Use prior to the Use By date. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . 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. The CAT family of catheters is the foundation of Penumbra's Indigo System. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. CAT8XTORQ115KIT-NS. 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. These pages are not intended for patients or for members of the general public. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Do not use in an oxygen rich environment. Brian Kolski, MD Figure 3. These pages are not intended for patients or for members of the general public. 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. gtag('js', new Date()); LIGHTNING Aspiration Tubing Indication for Use Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. 5 and 94. Interventional Cardiology Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Do not resterilize or reuse. Kingsport, Tennessee Penumbra Announces U.S. Commercial Availability of INDIGO System The INDIGO SEPARATOR 4 is not intended for use as a guidewire. N Engl J Med. Do not block bottom air vents. 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). Further evaluation of the returned device revealed kinks in the catheter shaft. 22. kolskiwellness@gmail.com suhail.dohad@cshs.org Penumbra, Inc. One Penumbra Place. $399.00 EACH. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for 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. sjaymathewsmd@gmail.com 0, and 37. Otherwise, this could result in degradation of the performance of this equipment. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: The penumbra cat8 indigo system (cat8) was kinked approximately 4. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. QUICK VIEW. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Director of Cardiac & Peripheral Cath Lab Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization Vedantham S, Goldhaber SZ, Julian JA, et al. How Penumbra's smart-sucking algorithms and catheters speed up clot It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. The Swan-Ganz catheter was exchanged over a long V18 wire. Do not use kinked or damaged devices. The removal of fibrous, adherent or calcified material (e.g. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 2015;372:1389-1398. 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. 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. The device is intended for single use only. Medical Director, Aortic Disease and Ischemic Limb Disease Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. PENUMBRA: SEP8 - Westcmr.com Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. This press release features multimedia. Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. 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 . Precautions Final angiogram showing resolution of extensive thrombus burden. chronic clot, atherosclerotic plaque) The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Catheters & Separators. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. It will reduce service life of the Penumbra ENGINE. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The CAT family of catheters is the foundation of Penumbra's Indigo system. 2023 Bryn Mawr Communications II, LLC. 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. . The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Return all damaged devices and packaging to the manufacturer/distributor. 0, 26. Distal posterior tibial artery emboli occlusion. 1. Learn more about Lightning. This is potentially more effective than diminished syringe-based aspiration. Do not use kinked or damaged devices. Indigo System CAT RX tracking through the distal posterior tibial artery. 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 built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. It will reduce the service life of the PENUMBRA ENGINE. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 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. Contraindications 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. INDIGO Aspiration Catheters and Separators: The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Figure 2. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. This website is intended for US audience only. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 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; and Suhail Dohad, MD, FACC. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Control angiography immediately after thrombectomy demonstrated restored patency . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. Return all damaged devices and packaging to the manufacturer/distributor. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. 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; Rethinking Thrombus Removal With the Indigo System: Introducing After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Return all damaged devices and packaging to the manufacturer/distributor. The results may vary depending on a variety of patient specific attributes. Randomized trial of primary PCI with or without routine manual thrombectomy. BJC Cardiology function gtag(){dataLayer.push(arguments);} 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. 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. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Lightning comes packaged with the Indigo CAT7 or CAT12. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Jolly SS, Cairns JA, Lavi S, et al. She had acute tubular necrosis with minimal urine output at the time of transfer.
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