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 built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. Copyright 2023 Penumbra, Inc. All rights reserved. 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 INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. 2015;372:1389-1398. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The product-specific content of this website is intended for use by healthcare professionals only. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC To prevent fire or shock hazard, use a replacement power cord of equal rating. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Initial angiography revealed an occlusion of the distal RCA. This website is intended for US audience only. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Interventional Cardiology Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use kinked or damaged devices. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. 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 oxygen rich environment. Figure 1. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Return all damaged devices and packaging to the manufacturer/distributor. After one pass with CAT RX, the initial occlusion was removed. 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. Figure 3. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 0, and 37. 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. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. window.dataLayer = window.dataLayer || []; The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Enter your email address and we will contact you. Created with Sketch. PENUMBRA: SEP8 - Westcmr.com 1. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Potential Adverse Events 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. The product-specific content of this website is intended for use by healthcare professionals only. UPC: Current Stock: . 2. The INDIGO Aspiration Tubing: 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 . Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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 re-infuse blood or fluid from the canister back into the patient. The CAT family of catheters is the foundation of Penumbras Indigo System. Maintain a constant infusion of appropriate flush solution. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Director, Structural Heart Jolly SS, Cairns JA, Lavi S, et al. 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. 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. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Chris Metzger, MD 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. Figure 2. 0 cm from the hub. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The treatment of arterial and venous thrombus is challenging. The complaint has been evaluated. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. chronic clot, atherosclerotic plaque) In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. 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. 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. 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). Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 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 means of mains disconnect is to remove the power cord. Maintain a constant infusion of appropriate flush solution. After IVUS, the stent was dilated to 3.75 mm. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Figure 3. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. INDIGO Aspiration System Intended Use Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. Return all damaged devices and packaging to the manufacturer/distributor. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. function gtag(){dataLayer.push(arguments);} 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. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Do not use open or damaged packages. The patient remained on cangrelor with no need for tirofiban. Bradenton Cardiology Center/Manatee Memorial Hospital 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. Do not use kinked or damaged devices. The Indigo System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). Indigo System | Computer-Aided Mechanical Aspiration. The Indigo System and CAT8 - Endovascular Today 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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 canister is intended for single use only. Penumbra ENGINE Intended Use 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. $399.00 EACH. Kingsport, Tennessee Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 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. 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 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 procedure can be performed quickly,1 which is important for symptomatic patients. UMassMemorial University Campus Figure 2. Conclusions: evaluation of the cat8 revealed that the device was fractured. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. . 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. If the cause cannot be determined, withdraw the device or system as a unit. This content is not intended to offer professional medical advice. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use in an oxygen rich environment. The device is intended for single use only. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. There were no cases of 30-day cardiovascular death or post procedural stroke. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove 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. window.dataLayer = window.dataLayer || []; PENUMBRA: CAT6 - WestCMR Saxon RR, Benenati JF, Teigen C, et al. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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 . Initial angiogram showing high thrombus burden in the RCA. Use only waterbased solvents for cleaning. S. Jay Mathews, MD, MS, FACC The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Use prior to the Use By date. Alameda, CA 94502. It will reduce service life of the Penumbra ENGINE. SVG occlusions can be challenging to resolve using traditional treatment modalities. Figure 2. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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 combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Catheters & Separators. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Otherwise, this could result in degradation of the performance of this equipment. Jolly SS, Cairns JA, Yusuf S, et al. Jawairia Sahar K. Mirza, MBBS 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.). She was in a rehab facility prior to this new event recovering from her CVA. Warnings US physicians publish "first reported use" of Indigo aspiration system 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. Medical Director, Aortic Disease and Ischemic Limb Disease Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and 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. Giri J, Sista AK, Weinberg J, et al. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. 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 . Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. No conversations found. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. gtag('js', new Date()); 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). function gtag(){dataLayer.push(arguments);} 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Throughout each case, Lightning provides procedural feedback via audio visual cues. Possible complications include, but are not limited to, the following: This website is intended for US audience only. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. J Am Coll Cardiol. Do not use open or damaged packages. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight 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. 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 laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Indication For Use The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Do not use open or damaged packages. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. 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). Return all damaged devices and packaging to the manufacturer/distributor. 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 . There was partial improvement of flow, but total occlusion remained. Indication For Use The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries.