Do not use in an oxygen rich environment. Warnings/Precautions The canister is intended for single use only. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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 following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Equipment is not safe for MR use. J Vasc Interv Radiol. Otherwise, this could result in degradation of the performance of this equipment. 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). Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Use only water-based solvents for cleaning. Maintain a constant infusion of appropriate flush solution. 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. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Indication For Use The pulmonary capillary wedge pressure is 10 mmHg. left-arrow The cat8 was kinked approximately 69. The canister is intended for single use only. No modification of this equipment is allowed. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Indication For Use 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. Figure 1. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Do not use open or damaged packages. window.dataLayer = window.dataLayer || []; Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Do not reuse. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 2018;29:92-100. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. 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. Figure 1. Mechanical thrombectomy was performed. Final angiogram showing resolution of extensive thrombus burden. 2019;140:e774-e801. Do not re-infuse blood or fluid from the canister back into the patient. This content is not intended to offer professional medical advice. 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). Only use replacement fuse with correct rating (see Table 1 for fuse rating). Do not resterilize or reuse. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Categories. The device is intended for single use only. Potential Adverse Events The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Lightning comes packaged with the Indigo CAT7 or CAT12. 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. Precautions The device is intended or single use only. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Indigo System CAT RX tracking through the distal posterior tibial artery. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 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 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. St. Joseph Hospital
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. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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. She was in a rehab facility prior to this new event recovering from her CVA. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Contraindications INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Device Name. Return all damaged devices and packaging to the manufacturer/ distributor. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. CAT RX is an essential tool in our percutaneous coronary armamentarium. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Do not use in oxygen rich environment. Photo: Courtesy of Business Wire. The results may vary depending on a variety of patient specific attributes. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. 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 . Do not block bottom air vents. The CAT family of catheters is the foundation of Penumbra's Indigo system. Jolly SS, Cairns JA, Lavi S, et al. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Jawairia Sahar K. Mirza, MBBS
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. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Use only waterbased solvents for cleaning. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Do not use in oxygen rich environment. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. Cedars Sinai Medical Center
She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Figure 3. Additional Details. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. Contraindications Learn more about Lightning. 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. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Created with Sketch. TIMI 3 flow was achieved in 88% of cases. Maintain a constant infusion of appropriate flush solution. 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. 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: PENUMBRA ENGINE Indication for Use The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 1. LIGHTNING Aspiration Tubing Indication for Use 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 . Contraindications Figure 2. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 2015;372:1389-1398. 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. 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. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). The system uses Penumbra's RED reperfusion catheters. 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. Potential Adverse Events Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Waqas R. Qureshi, MD, MS
Chris Metzger, MD
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 safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Contraindications There are no contraindications. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. Director of Cardiac Catheterization Lab, PERT & Structural Heart
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. Precautions The device is intended for single use only. 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. Enter your email address and we will contact you. Potential Adverse Events J Am Coll Cardiol. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon 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. INDIGO System LIGHTNING Aspiration Tubing Intended Use Tareq Kass-Hout. Giri J, Sista AK, Weinberg J, et al. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Precautions Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Not for use in the coronaries or the neurovasculature. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. The CAT family of catheters is the foundation of Penumbra's Indigo system. Warnings INDIGO Aspiration System Indication for Use If the cause cannot be determined, withdraw the device or system as a unit. Worcester, Massachusetts
Do not reuse. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. (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. Orange, California
The complaint indicated that the cat8 was kinked during the procedure. 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. 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 Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. kolskiwellness@gmail.com
Figure 3. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . This content is not intended to offer professional medical advice. 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. gtag('js', new Date()); 1. Separator 8, 150 cm Length, 0.072 in. Use prior to the Use By date. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Interventional Cardiology