gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not resterilize or reuse. Indigo System | Computer-Aided Mechanical Aspiration. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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 . excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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 . Prior to use, please consult device labeling and instructions for use. Do not block bottom air vents. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. 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. 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. 2023 Bryn Mawr Communications II, LLC. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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. She was in a rehab facility prior to this new event recovering from her CVA. waqas.qureshi@umassmemorial.org 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. Do not use kinked or damaged devices. Figure 3. Distal emboli causing PDA occlusion after manual aspiration. This website is intended for US audience only. IN-DATE. Indigo System CAT RX tracking through the distal posterior tibial artery. This press release features multimedia. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Possible complications include, but are not limited to, the following: $399.00 EACH. Do not use kinked or damaged devices. Learn more about Lightning. Lightning comes packaged with the Indigo CAT7 or CAT12. Alameda, CA 94502. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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. (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. Do not resterilize or reuse. The CAT family of catheters is the foundation of Penumbra's Indigo system. window.dataLayer = window.dataLayer || []; Precautions The device is intended or single use only. Final angiogram showing resolution of extensive thrombus burden. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Figure 2. 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. Figure 1. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Contraindications There are no known contraindications. 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 newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics . Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. function gtag(){dataLayer.push(arguments);} Vascular Thrombectomy. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Do not resterilize or reuse. Prior to use, please consult device labeling and instructions for use. 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. UPC: Current Stock: This item is out of stock. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Return all damaged devices and packaging to the manufacturer/ distributor. Indication For Use The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. This is potentially more effective than diminished syringe-based aspiration. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 0, 26. 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 . If the cause cannot be determined, withdraw the device or system as a unit. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. 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 patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. S. Jay Mathews, MD, MS, FACC Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The cat8 was kinked approximately 69. Do not use open or damaged packages. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Figure 2. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. Contraindications Not for use in the coronaries or the neurovasculature. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Jolly SS, Cairns JA, Lavi S, et al. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Do not re-infuse blood or fluid from the canister back into the patient. 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. Flow through left circumflex artery post-CAT RX. Mechanical thrombectomy was performed. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Do not use open or damaged packages. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Tareq Kass-Hout. Maintain a constant infusion of appropriate flush solution. Use prior to the Use By date. Chris Metzger, MD N Engl J Med. 5, 19. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Figure 1. 3. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Copyright 2023 Penumbra, Inc. All rights reserved. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. UMassMemorial University Campus 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 were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). Created with Sketch. System Chair, Clinical Research 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. 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. Return all damaged devices and packaging to the manufacturer/distributor. 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. 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. 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. Do not use in oxygen rich environment. We presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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: Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Copyright 2023 Penumbra, Inc. All rights reserved. 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 final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. INDIGO Aspiration Catheters and Separators: Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. This website is intended for US audience only. . The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). 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. 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. Photo: Courtesy of Business Wire. Missouri Baptist Medical Center Initial angiogram of the right pulmonary artery showing pulmonary embolism. University of Massachusetts Medical School gtag('js', new Date()); INDIGO Aspiration System Intended Use To prevent fire or shock hazard, use a replacement power cord of equal rating. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. 5, 21. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The Indigo System utilizes the Penumbra ENGINEaspiration 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. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . INDIGO System LIGHTNING Aspiration Tubing Intended Use 1. Do not resterilize or reuse. Do not reuse. 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. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. kolskiwellness@gmail.com This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Figure 2. 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. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Mechanical Thrombectomy. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. After one pass with CAT RX, the initial occlusion was removed. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. Contraindications Final angiographic result of SVG. 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. Conclusions: evaluation of the cat8 revealed that the device was fractured. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . The means of mains disconnect is to remove the power cord. 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 complaint has been evaluated. Do not use open or damaged packages. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 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). Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Director of Cardiac & Peripheral Cath Lab The product-specific content of this website is intended for use by healthcare professionals only. The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. 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 patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. 22. Enter your email address and we will contact you. Contraindications 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. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral . 5 and 94. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Use prior to the Use By date. The pain became more intense and constant, so he presented to the ED. Saxon RR, Benenati JF, Teigen C, et al. suhail.dohad@cshs.org CAT RX is an essential tool in our percutaneous coronary armamentarium. 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. 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. The Indigo Aspiration System is contraindicated in: Contraindications There are no known contraindications. Saint Louis, Missouri 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. 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). Potential Adverse Events right-arrow CAT7 and CAT12 are the next generation of the Indigo System catheters. The procedure can be performed quickly,1 which is important for symptomatic patients. sjaymathewsmd@gmail.com We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. 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. Potential Adverse Events The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Initial angiogram showing high thrombus burden in the RCA. Vedantham S, Goldhaber SZ, Julian JA, et al. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli.

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