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If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Contraindications There are no known contraindications. 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. Do not use in oxygen rich environment. Potential Adverse Events After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Created with Sketch. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. The device is intended for single use only. The product-specific content of this website is intended for use by healthcare professionals only. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. UPC: Current Stock: . 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. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). Precautions Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. Penumbra Announces U.S. Commercial Availability of INDIGO System All Rights Reserved Privacy Policy, 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; Suhail Dohad, MD, FACC. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Worcester, Massachusetts Worcester, Massachusetts 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. 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. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Disclosures: None. Maintain a constant infusion of appropriate flush solution. Indigo System Catheters & Separators | Penumbra Inc Saxon RR, Benenati JF, Teigen C, et al. 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 . Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. No conversations found. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Penumbra's high-performance aspiration catheters. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. 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: Warnings Flow through left circumflex artery post-CAT RX. The means of mains disconnect is to remove the power cord. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Do not resterilize or reuse. 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. Figure 2. 8: Add BMK6F95M-NE . Throughout each case, Lightning provides procedural feedback via audiovisual cues. function gtag(){dataLayer.push(arguments);} K180412. Penumbra ENGINE Intended Use 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). A, Penumbra Indigo System Continuous Aspiration - ResearchGate Indication For Use Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. If the cause cannot be determined, withdraw the device or system as a unit. Latest System Designed for Single Session Arterial Thrombus Removal News A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc After IVUS, the stent was dilated to 3.75 mm. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. 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. No modification of this equipment is allowed. 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 She had acute tubular necrosis with minimal urine output at the time of transfer. INDIGO Aspiration System Intended Use 2019;140:e774-e801. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 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 . Warnings/Precautions The canister is intended for single use only. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization 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. 1. Do not reuse. Contraindications There are no known contraindications. The means of mains disconnect is to remove the power cord. Mechanical thrombectomy was performed. Do not use open or damaged packages. 0, and 37. Mechanical Thrombectomy. Photo: Courtesy of Business Wire. 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 . Figure 1. The complaint has been evaluated. Learn more about Lightning. 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. There was partial improvement of flow, but total occlusion remained. 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. 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 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. Potential Adverse Events This is potentially more effective than diminished syringe-based aspiration. The Indigo Aspiration System is contraindicated in: Use prior to the Use By date. 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. 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. 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. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Circulation. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Precautions The device is intended for single use only. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbra Cat 8 - IndiaMART 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. The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use kinked or damaged devices. 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. Indigo System Intended Use Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Figure 3. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Use prior to the Use By date. Ultrasound-guided access was obtained through the right femoral vein. Orange, California 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. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality The Indigo System and CAT8 - Endovascular Today right-arrow Rethinking Thrombus Removal With the Indigo System: Introducing Potential Adverse Events 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. Contraindications Not for use in the coronaries or the neurovasculature. Do not use kinked or damaged devices. 1. Prior to use, please consult device labeling and instructions for use. gtag('js', new Date()); Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Do not use open or damaged packages. 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 CAT familyof catheters is the foundation of Penumbras Indigo System. Contraindications CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. waqas.qureshi@umassmemorial.org Enter your email address and we will contact you. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Final angiogram showing resolution of extensive thrombus burden. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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). CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Next Article After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Indigo System CAT RX tracking through the distal posterior tibial artery. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The complaint indicated that the cat8 was kinked during the procedure. Return all damaged devices and packaging to the manufacturer/distributor. TIMI 3 flow was achieved in 88% of cases. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC This is potentially more effective than diminished syringe-based aspiration. 2. Return all damaged devices and packaging to the manufacturer/distributor. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The product-specific content of this website is intended for use by healthcare professionals only. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Gus Theodos, MD, FACC, FSCAI If the cause cannot be determined, withdraw the device or system as a unit. The product-specific content of this website is intended for use by healthcare professionals only. Director, Structural Heart The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Figure 2. 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 with LIGHTNING Aspiration Tubing Indication for Use Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. The penumbra cat8 indigo system (cat8) was kinked approximately 4. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. Do not use kinked or damaged devices. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. gtag('js', new Date()); Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. US physicians publish "first reported use" of Indigo aspiration system 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 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. 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 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. This press release features multimedia. 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. Penumbra System Products - Medical Materials The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Final angiographic result of SVG. 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 . 0, 26. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA 3. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Do not resterilize or reuse. Alameda, CA 94502. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The removal of fibrous, adherent or calcified material (e.g. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 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.
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