MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Otherwise, this could result in degradation of the performance of this equipment. Distal emboli causing PDA occlusion after manual aspiration. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. Penumbra's high-performance aspiration catheters. 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.). Maintain a constant infusion of appropriate flush solution. Throughout each case, Lightning provides procedural feedback via audio visual cues. Potential Adverse Events The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. BJC Cardiology The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. The device is intended for single use only. The canister is intended for single use only. PENUMBRA ENGINE Indication for Use Return all damaged devices and packaging to the manufacturer/distributor. Warnings Potential Adverse Events Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Potential Adverse Events gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. Penumbra Aspiration Pump: Do not use kinked or damaged devices. Jolly SS, Cairns JA, Lavi S, et al. Do not use kinked or damaged devices. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. 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. This press release features multimedia. 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. Use only water-based solvents for cleaning. INDIGO Aspiration System Indication for Use 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. The Indigo Aspiration System is contraindicated in: 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. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). 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. 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 Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Saxon RR, Benenati JF, Teigen C, et al. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. 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. PENUMBRA ENGINE Intended Use gtag('js', new Date()); The results may vary depending on a variety of patient specific attributes. Penumbra ENGINE Intended Use Cedars Sinai Medical Center CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. 8: Add BMK6F95M-NE . The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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: If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Copyright 2023 Penumbra, Inc. All rights reserved. Do not use in an oxygen rich environment. Do not resterilize or reuse. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Smidt Heart institute Waqas R. Qureshi, MD, MS Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Figure 2. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. These pages are not intended for patients or for members of the general public. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. This content is not intended to offer professional medical advice. 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. 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. Do not use kinked or damaged devices. The CAT family of catheters is the foundation of Penumbra's Indigo System. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. Additional Details. The product-specific content of this website is intended for use by healthcare professionals only. 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. 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. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Penumbra ENGINE Indication For Use The CAT family of catheters is the foundation of Penumbra's Indigo System. How Penumbra's smart-sucking algorithms and catheters speed up clot Warnings/Precautions The canister is intended for single use only. 5, 21. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 2018;29:92-100. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. CAT RX has allowed us to rethink how we approach these occluded SVGs. 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 . The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. Do not re-infuse blood or fluid from the canister back into the patient. INDIGO Aspiration System Intended Use 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. Figure 2. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 0 cm from the hub. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 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). 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 INDIGO Aspiration Tubing: Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Penumbra Announces U.S. Commercial Availability of INDIGO System Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. PENUMBRA: SEP8 - Westcmr.com Use prior to the Use By date. Available in a selection of sizes, the CAT family can provide access to distal peripheral . A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. gtag('js', new Date()); 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. 2. Penumbra System Products - Medical Materials Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. Penumbra, Inc. One Penumbra Place. 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. Do not use kinked or damaged devices. Potential Adverse Events Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. 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. 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. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. To prevent fire or shock hazard, use a replacement power cord of equal rating. Contraindications There are no known contraindications. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. 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. 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. Penumbra Announces U.S. Commercial Availability of INDIGO System The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Latest System Designed for Single Session Arterial Thrombus Removal News The Indigo System and CAT8 - Endovascular Today Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 2019;140:e774-e801. Indication For 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. Do not use open or damaged packages. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 510(k) Premarket Notification - Food And Drug Administration A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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 with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Figure 1. Indigo System CAT RX | Penumbra Inc The treatment of arterial and venous thrombus is challenging. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Enter your email address and we will contact you. Use prior to the Use By date. Do not resterilize or reuse. These pages are not intended for patients or for members of the general public. Gus Theodos, MD, FACC, FSCAI Catheters & Separators. Figure 1. Return all damaged devices and packaging to the manufacturer/ distributor. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. 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. This is potentially more effective than diminished syringe-based aspiration. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Ultrasound-guided access was obtained through the right femoral vein. Return all damaged devices and packaging to the manufacturer/distributor. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . UMassMemorial University Campus For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Director of Cardiac & Peripheral Cath Lab Do not block bottom or back air vents. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). A, Penumbra Indigo System Continuous Aspiration - ResearchGate Figure 1. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Distal posterior tibial artery emboli occlusion. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. 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). Figure 2. Categories. INDIGO Aspiration System Intended Use These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. The Indigo Separator 4 is not intended for use as a guidewire. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Do not use kinked or damaged devices. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. The CAT familyof catheters is the foundation of Penumbras Indigo System. Created with Sketch. Copyright 2022 Penumbra, Inc. All rights reserved. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Do not use open or damaged packages. J Vasc Interv Radiol. The INDIGO SEPARATOR is not intended for use as a guidewire. Figure 2. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Kingsport, Tennessee No modification of this equipment is allowed. 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 If the cause cannot be determined, withdraw the device or system as a unit. Otherwise, this could result in degradation of the performance of this equipment. 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. Flow through left circumflex artery post-CAT RX. The procedure can be performed quickly,1 which is important for symptomatic patients. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Warnings/Precautions Final angiographic result of SVG. Contraindications 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.