The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. 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. The results may vary depending on a variety of patient specific attributes. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). . 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. Figure 1. The CAT family of catheters is the foundation of Penumbra's Indigo System. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. After IVUS, the stent was dilated to 3.75 mm. 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 block bottom air vents. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Applicant. J Am Coll Cardiol. 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. Order Qty. To prevent fire or shock hazard, use a replacement power cord of equal rating. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Orange, California CAT RX is an essential tool in our percutaneous coronary armamentarium. Only use replacement fuse with correct rating (see Table 1 for fuse rating). For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. (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. The pulmonary capillary wedge pressure is 10 mmHg. Figure 2. Gus Theodos, MD, FACC, FSCAI Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Distal OD. 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. This press release features multimedia. chronic clot, atherosclerotic plaque) The penumbra cat8 indigo system (cat8) was kinked approximately 4. N Engl J Med. The system uses Penumbra's RED reperfusion catheters. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). If the cause cannot be determined, withdraw the device or system as a unit. The device is intended for single use only. 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. INDIGO Aspiration Tubing: 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 . Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). 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 CAT family of catheters is the foundation of Penumbras Indigo System. window.dataLayer = window.dataLayer || []; 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 . Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. INDIGO Aspiration Catheters and Separators: Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Suhail Dohad, MD, FACC Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Figure 3. System Chair, Clinical Research 1. 2019;140:e774-e801. It will reduce the service life of the PENUMBRA ENGINE. Device Name. CAT7 and CAT12 are the next generation of the Indigo System catheters. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . These types of burns heal withing 5 or 6 days without permanent scarring. Copyright 2023 Penumbra, Inc. All rights reserved. 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. 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. Distal emboli causing PDA occlusion after manual aspiration. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. 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. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. The PENUMBRA ENGINE 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. Do not use kinked or damaged devices. The complaint indicated that the cat8 was kinked during the procedure. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). If the cause cannot be determined, withdraw the device or system as a unit. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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. The INDIGO SEPARATOR is not intended for use as a guidewire. 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. Potential Adverse Events Otherwise, this could result in degradation of the performance of this equipment. 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. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not re-infuse blood or fluid from the canister back into the patient. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. 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. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. The Indigo Aspiration System is contraindicated in: Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Return all damaged devices and packaging to the manufacturer/distributor. The low-profile catheter and Penumbra . Director, Structural Heart 2015;372:1389-1398. Use prior to the Use By date. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. function gtag(){dataLayer.push(arguments);} 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. Contraindications Not for use in the coronaries or the neurovasculature. 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. 2017;377:2240-2252. 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 in an oxygen rich environment. Figure 3. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. This content is not intended to offer professional medical advice. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. UPC: Current Stock: . Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Contraindications There are no contraindications. 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. These pages are not intended for patients or for members of the general public. Return all damaged devices and packaging to the manufacturer/distributor. Final angiogram after stent placement showing resolution of underlying disease.
Rhinestone Stretch Mesh Fabric,
Raising Cane's Marketing Strategy,
Akron, Ohio Crime Rate,
How Much Do Pecos League Players Make,
Miami Northwestern Senior High Class Of 2021,
Articles C