Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Warnings Do not use open or damaged packages. This is potentially more effective than diminished syringe-based aspiration. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Brian Kolski, MD
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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Suhail Dohad, MD, FACC
right-arrow Medical Director, Aortic Disease and Ischemic Limb Disease
She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. gtag('js', new Date()); Initial angiogram of the right pulmonary artery showing pulmonary embolism. There were no cases of 30-day cardiovascular death or post procedural stroke. The system uses Penumbra's RED reperfusion catheters. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Do not resterilize or reuse. Return all damaged devices and packaging to the manufacturer/distributor. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. 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. No modification of this equipment is allowed. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The CAT familyof catheters is the foundation of Penumbras Indigo System. 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. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Return all damaged devices and packaging to the manufacturer/distributor. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. N Engl J Med. The product-specific content of this website is intended for use by healthcare professionals only. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 0 cm from the distal tip. Contraindications There are no known contraindications. TIMI 3 flow was achieved in 88% of cases. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Equipment is not safe for MR use. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Additional Details. Vascular Thrombectomy. 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. left-arrow 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. 0, 26. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 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 . Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. The pain became more intense and constant, so he presented to the ED. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. 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. Do not use kinked or damaged devices. As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Do not re-infuse blood or fluid from the canister back into the patient. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 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. 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. Use prior to the Use By date. sjaymathewsmd@gmail.com
0 cm from the hub. 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. These pages are not intended for patients or for members of the general public. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 0, 24. Figure 3. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Copyright 2022 Penumbra, Inc. All rights reserved. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. INDIGO Aspiration System Intended Use Equipment is not safe for MR use. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. 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. Flow through left circumflex artery post-CAT RX. Learn more about Lightning. Jolly SS, Cairns JA, Yusuf S, et al. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. This website is intended for US audience only. UMassMemorial University Campus
8: Add BMK6F95M-NE . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Copyright 2023 Penumbra, Inc. All rights reserved. Mechanical thrombectomy was performed. 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. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Order Qty. 2018;72:1589-1596. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Do not resterilize or reuse. The INDIGO SEPARATOR is not intended for use as a guidewire. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. J Am Coll Cardiol. Potential Adverse Events Latest System Designed for Single Session Arterial Thrombus Removal News Gus Theodos, MD, FACC, FSCAI
Waqas R. Qureshi, MD, MS
System Chair, Clinical Research
function gtag(){dataLayer.push(arguments);} Disclosures: None. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. 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. 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. 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. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 5, 21. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. S. Jay Mathews, MD, MS, FACC
Figure 3. Jawairia Sahar K. Mirza, MBBS
The procedure was completed with the same catheter. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. Distal posterior tibial artery emboli occlusion. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. The low-profile catheter and Penumbra . No conversations found. These pages are not intended for patients or for members of the general public. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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. minimalism: a documentary about the important things transcript; cat8 penumbra catheter; i 75 road construction cincinnati; tocaya west hollywood; best places to live in alabama near the. 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 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. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). 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; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. 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. 1. Cedars Sinai Medical Center
0, 23. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Return all damaged devices and packaging to the manufacturer/distributor. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Created with Sketch. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Do not reuse. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. (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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. K180412. SVG occlusions can be challenging to resolve using traditional treatment modalities. Figure 1. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The INDIGO Aspiration Tubing: The Indigo System utilises the Penumbra ENGINE aspiration 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Otherwise, this could result in degradation of the performance of this equipment. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Copyright 2022 Penumbra, Inc. All rights reserved. 1. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 5, 19. QUICK VIEW. 2023 Bryn Mawr Communications II, LLC. Los Angeles, California
Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. UPC: Current Stock: This item is out of stock. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Use prior to the Use By date. Brandenton, Florida
There are no contraindications. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Do not use open or damaged packages. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 2. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Return all damaged devices and packaging to the manufacturer/ distributor. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. 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. 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.