Additional Details. This is potentially more effective than diminished 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. Use prior to the Use By date. This website is intended for US audience only. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Indigo System Intended Use St. Joseph Hospital Do not re-infuse blood or fluid from the canister back into the patient. Enter your email address and we will contact you. Further evaluation of the returned device revealed kinks in the catheter shaft. Device Name. Control angiography immediately after thrombectomy demonstrated restored patency . 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). Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . The product-specific content of this website is intended for use by healthcare professionals only. Catheters & Separators. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon QUICK VIEW. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Ultrasound-guided access was obtained through the right femoral vein. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Missouri Baptist Medical Center Warnings/Precautions 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. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. 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. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Do not resterilize or reuse. 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. These pages are not intended for patients or for members of the general public. Copyright 2023 Penumbra, Inc. All rights reserved. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Aspiration Tubing Intended Use The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Contraindications There are no known contraindications. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 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. 0, 24. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Do not resterilize or reuse. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Use only waterbased solvents for cleaning. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Do not use open or damaged packages. These pages are not intended for patients or for members of the general public. 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: Saint Louis, Missouri The procedure can be performed quickly,1 which is important for symptomatic patients. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Disclosures: None. 0, 26. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. The device is intended for single use only. Photo: Courtesy of Business Wire. 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 canister is intended for single use only. If the cause cannot be determined, withdraw the device or system as a unit. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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.). Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 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. 2015;372:1389-1398. Otherwise, this could result in degradation of the performance of this equipment. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Giri J, Sista AK, Weinberg J, et al. The CAT familyof catheters is the foundation of Penumbras Indigo System. Copyright 2022 Penumbra, Inc. All rights reserved. CAT RX is an essential tool in our percutaneous coronary armamentarium. 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. UMassMemorial University Campus Potential Adverse Events 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. 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. 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. 22. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Chris Metzger, MD Penumbra ENGINE Indication For Use Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Do not use kinked or damaged devices. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. 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. 1. 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. J Vasc Interv Radiol. Figure 3. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. 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 . It will reduce service life of the Penumbra ENGINE. Do not resterilize or reuse. This site is protected by reCAPTCHA and the Google, 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 Intelligent Aspiration comes packaged with CAT7, CAT8 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. Use only water-based solvents for cleaning. Figure 2. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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 . There was partial improvement of flow, but total occlusion remained. TIMI 3 flow was achieved in 88% of cases. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 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. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. 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 means of mains disconnect is to remove the power cord. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Throughout each case, Lightning provides procedural feedback via audio visual cues. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . 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. Indigo System | Computer-Aided Mechanical Aspiration. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Smidt Heart institute When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not use open or damaged packages. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . After IVUS, the stent was dilated to 3.75 mm. 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. Figure 1. CAT RX has allowed us to rethink how we approach these occluded SVGs. Copyright 2023 Penumbra, Inc. All rights reserved. There are no contraindications. right-arrow Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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. Jawairia Sahar K. Mirza, MBBS Penumbra ENGINE Intended Use Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. kolskiwellness@gmail.com She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . 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 Swan-Ganz catheter was exchanged over a long V18 wire. suhail.dohad@cshs.org 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. This website is intended for US audience only. 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. These types of burns heal withing 5 or 6 days without permanent scarring. Potential Adverse Events 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. Use prior to the Use By date. 2: Add Maintain a constant infusion of appropriate flush solution. 1. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The INDIGO Aspiration Tubing: 1. Warnings Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The cerebral vasculature 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. 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. . . Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). 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 procedure was completed with the same catheter.