Disclosures: None. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Figure 2. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Precautions 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. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Vascular Thrombectomy. Control angiography immediately after thrombectomy demonstrated restored patency . Contraindications This content is not intended to offer professional medical advice. Worcester, Massachusetts Worcester, Massachusetts The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Gus Theodos, MD, FACC, FSCAI The pain became more intense and constant, so he presented to the ED. CAT7 and CAT12 are the next generation of the Indigo System catheters. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart CAT8XTORQ115KIT-NS. 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 pulmonary capillary wedge pressure is 10 mmHg. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. There are no contraindications. Learn more about Lightning. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. Figure 2. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. 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. 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. Further evaluation of the returned device revealed kinks in the catheter shaft. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). Photo: Courtesy of Business Wire. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. 0, 26. The device is intended for single use only. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Possible complications include, but are not limited to, the following: The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Figure 1. . These pages are not intended for patients or for members of the general public. 5, 19. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Figure 1. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Jawairia Sahar K. Mirza, MBBS 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 reuse. Copyright 2023 Penumbra, Inc. All rights reserved. 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. Enter your email address and we will contact you. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. INDIGO Aspiration Catheters and Separators: Do not use kinked or damaged devices. N Engl J Med. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Cedars Sinai Medical Center 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. Figure 1. Do not use kinked or damaged devices. Mechanical Thrombectomy. Penumbra, Inc. One Penumbra Place. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight 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. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Missouri Baptist Medical Center Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The INDIGO SEPARATOR is not intended for use as a guidewire. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. The cerebral vasculature right-arrow Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. No conversations found. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. Return all damaged devices and packaging to the manufacturer/distributor. If the cause cannot be determined, withdraw the device or system as a unit. 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. 3. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Return all damaged devices and packaging to the manufacturer/distributor. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Return all damaged devices and packaging to the manufacturer/distributor. Sista A. Indigo aspiration system for acute pulmonary embolism. How Penumbra's smart-sucking algorithms and catheters speed up clot 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). If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The product-specific content of this website is intended for use by healthcare professionals only. 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. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. The CAT familyof catheters is the foundation of Penumbras Indigo System. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 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). 2018;29:92-100. Copyright 2023 Penumbra, Inc. All rights reserved. Penumbra Aspiration Pump: Mathews SJ, Brown C, Kolski B, et al. 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. allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. It will reduce the service life of the PENUMBRA ENGINE. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. 0, and 37. There was partial improvement of flow, but total occlusion remained. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Tareq Kass-Hout. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Maintain a constant infusion of appropriate flush solution. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . After one pass with CAT RX, the initial occlusion was removed. Lightning comes packaged with the Indigo CAT7 or CAT12. 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 Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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 Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. The removal of fibrous, adherent or calcified material (e.g. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. The low-profile catheter and Penumbra . Director of Cardiac Catheterization Lab, PERT & Structural Heart Copyright 2022 Penumbra, Inc. All rights reserved. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Use only waterbased solvents for cleaning. 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. INDIGO System LIGHTNING Aspiration Tubing Intended Use Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. The product-specific content of this website is intended for use by healthcare professionals only. $399.00 EACH. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. PENUMBRA: CAT6 - WestCMR Figure 2. 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. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Indigo System Catheters & Separators | Penumbra Inc Initial angiogram of the right pulmonary artery showing pulmonary embolism. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Separator 8, 150 cm Length, 0.072 in. Penumbra Announces U.S. Commercial Availability of INDIGO System A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). Potential Adverse Events 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. The results may vary depending on a variety of patient specific attributes. Device Name. Distal emboli causing PDA occlusion after manual aspiration. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION If the cause cannot be determined, withdraw the device or system as a unit. Figure 3. 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 . Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Indigo System Catheters & Separators | Penumbra Inc 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. Director, Structural Heart 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. 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. 2023 Bryn Mawr Communications II, LLC. Do not use kinked or damaged devices. TIMI 3 flow was achieved in 88% of cases. She was in a rehab facility prior to this new event recovering from her CVA. Initial angiogram showing high thrombus burden in the RCA. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 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. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Potential Adverse Events 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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; Equipment is not safe for MR use. N Engl J Med. 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, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: 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. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. Available in a selection of sizes, the CAT family can provide access to distal peripheral . When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Final angiogram showing resolution of extensive thrombus burden. 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 . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Not for use in the coronaries or the neurovasculature. This press release features multimedia. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Indigo System | Penumbra Inc Distal OD. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. waqas.qureshi@umassmemorial.org Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Contraindications BJC Cardiology Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 22. (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. 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. The INDIGO SEPARATOR is not intended for use as a guidewire.