The INDIGO SEPARATOR 4 is not intended for use as a guidewire. 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. 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; Director of Cardiac & Peripheral Cath Lab Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Use prior to the Use By date. Los Angeles, California 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. Not for use in the coronaries or the neurovasculature. Do not use in oxygen rich environment. CAT RX has allowed us to rethink how we approach these occluded SVGs. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. 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. After one pass with CAT RX, the initial occlusion was removed. Potential Adverse Events Penumbra's not relying on software alone. 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. This is potentially more effective than diminished syringe-based aspiration. Do not use kinked or damaged devices. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Do not use in oxygen rich environment. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. LIGHTNING Aspiration Tubing Indication for Use In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). The pain became more intense and constant, so he presented to the ED. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. 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 the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm There was partial improvement of flow, but total occlusion remained. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Equipment is not safe for MR use. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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). Suhail Dohad, MD, FACC She was in a rehab facility prior to this new event recovering from her CVA. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. SVG occlusions can be challenging to resolve using traditional treatment modalities. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Device Name. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. System Chair, Clinical Research Indigo System CAT RX | Penumbra Inc 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. Do not use open or damaged packages. 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 . SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization 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 the PENUMBRA ENGINE. If the cause cannot be determined, withdraw the device or system as a unit. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). The Indigo Separator 4 is not intended for use as a guidewire. Do not resterilize or reuse. 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. Kingsport, Tennessee Do not resterilize or reuse. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Contraindications There are no contraindications. Contraindications There are no known contraindications. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . 5, 21. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). These types of burns heal withing 5 or 6 days without permanent scarring. IN-DATE. The cat8 was kinked approximately 69. 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. Next Article Mechanical thrombectomy was performed. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Contraindications Not for use in the coronaries or the neurovasculature. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. 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. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Do not reuse. 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. Saxon RR, Benenati JF, Teigen C, et al. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Computer-Aided Aspiration comes packaged with CAT7 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Separator 8, 150 cm Length, 0.072 in. 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. Do not block bottom or back air vents. 5 and 94. 510 (k) Number. It will reduce the service life of the PENUMBRA ENGINE. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. . The means of mains disconnect is to remove the power cord. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 3. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. 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 introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Penumbra's high-performance aspiration catheters. 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). Worcester, Massachusetts 0, and 37. N Engl J Med. To prevent fire or shock hazard, use a replacement power cord of equal rating. Giri J, Sista AK, Weinberg J, et al. Final angiogram showing resolution of extensive thrombus burden. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Jolly SS, Cairns JA, Yusuf S, et al. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Photo: Courtesy of Business Wire. The product-specific content of this website is intended for use by healthcare professionals only. QUICK VIEW. 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. 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. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. INDIGO Aspiration System Intended Use With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. gtag('js', new Date()); 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. Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. No modification of this equipment is allowed. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for 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. Copyright 2023 Penumbra, Inc. All rights reserved. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Distal OD. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. gtag('js', new Date()); Catheters & Separators. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 UPC: Current Stock: This item is out of stock. 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. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. If the cause cannot be determined, withdraw the device or system as a unit. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. Indigo Aspiration System Intended Use Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 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. Further evaluation of the returned device revealed kinks in the catheter shaft. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Penumbra ENGINE Intended Use Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Penumbra Announces U.S. Commercial Availability of INDIGO System Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Final angiogram after stent placement showing resolution of underlying disease. Penumbra Announces U.S. Commercial Availability of INDIGO System Do not resterilize or reuse. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. 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 . 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. No modification of this equipment is allowed. Units in stock: 1. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Figure 3. Do not resterilize or reuse. 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. Use prior to the Use By date. This content is not intended to offer professional medical advice. Warnings/Precautions Available in a selection of sizes, the CAT family can provide access to distal peripheral . Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Flow through left circumflex artery post-CAT RX. Precautions The device is intended for single use only. Bradenton Cardiology Center/Manatee Memorial Hospital Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Prior to use, please consult device labeling and instructions for use. 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. PENUMBRA: CAT6 - WestCMR If the cause cannot be determined, withdraw the device or system as a unit. The INDIGO Aspiration System 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. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI.
Pennsylvania Public Restroom Laws, Survivor Mark Burnett Net Worth, Articles C