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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. Additional Details. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. 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. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Prior to use, please consult device labeling and instructions for use. The Indigo Aspiration System is contraindicated in: Further evaluation of the returned device revealed kinks in the catheter shaft. This content is not intended to offer professional medical advice. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. 2. gtag('js', new Date()); Return all damaged devices and packaging to the manufacturer/distributor. Potential Adverse Events Mathews SJ, Brown C, Kolski B, et al. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Return all damaged devices and packaging to the manufacturer/distributor. The CAT family of catheters is the foundation of Penumbras Indigo System. Do not resterilize or reuse. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Potential Adverse Events Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 2023 Bryn Mawr Communications II, LLC. 510 (k) Number. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Do not use kinked or damaged devices. gus.theodos@bjc.org; @gtheodosmd gtag('js', new Date()); INDIGO Aspiration System Indication for Use For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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). Precautions The device is intended for single use only. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Figure 2. window.dataLayer = window.dataLayer || []; The CAT familyof catheters is the foundation of Penumbras Indigo System. 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 CAT family of catheters is the foundation of Penumbra's Indigo system. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Contraindications There are no contraindications. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Do not re-infuse blood or fluid from the canister back into the patient. Cedars Sinai Medical Center 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. Maintain a constant infusion of appropriate flush solution. 5, 19. 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. Figure 1. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). 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. No conversations found. Do not reuse. Precautions The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Initial angiogram of the right pulmonary artery showing pulmonary embolism. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a 0, 24. 2018;72:1589-1596. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Return all damaged devices and packaging to the manufacturer/distributor. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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). 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. Final angiographic result of SVG. Throughout each case, Lightning provides procedural feedback via audio visual cues. The cat8 was kinked approximately 69. The complaint indicated that the cat8 was kinked during the procedure. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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 in oxygen rich environment. Use prior to the Use By date. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. 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. Worcester, Massachusetts Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. There are no contraindications. CAT RX has allowed us to rethink how we approach these occluded SVGs. Copyright 2023 Penumbra, Inc. All rights reserved. Initial angiography revealed an occlusion of the distal RCA. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. 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. Director of Cardiac Catheterization Lab, PERT & Structural Heart Control angiography immediately after thrombectomy demonstrated restored patency . Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . 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. Warnings/Precautions The canister 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. 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. Smidt Heart institute The Swan-Ganz catheter was exchanged over a long V18 wire. PENUMBRA ENGINE Intended Use Maintain a constant infusion of appropriate flush solution. 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. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). The Indigo Separator 4 is not intended for use as a guidewire. Contraindications 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. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Use prior to the Use By date. 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: Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 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). Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). 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. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 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 use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not use kinked or damaged devices. CAT8XTORQ115KIT-NS. 0, 23. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. It will reduce service life of the Penumbra ENGINE. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. It will reduce the service life of the PENUMBRA ENGINE. INDIGO Aspiration Catheters and Separators: Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. Distal OD. 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 . A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Mechanical thrombectomy was performed. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Contraindications 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Otherwise, this could result in degradation of the performance of this equipment. 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not resterilize or reuse. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. LIGHTNING Aspiration Tubing Indication for Use Figure 2. Do not use open or damaged packages. function gtag(){dataLayer.push(arguments);} TIMI 3 flow was achieved in 88% of cases. Enter your email address and we will contact you. 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. Penumbra, Inc. One Penumbra Place. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. 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. kolskiwellness@gmail.com The product-specific content of this website is intended for use by healthcare professionals only. 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. 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 use in the presence of a flammable anesthetic mixture with air or nitrous oxide. J Am Coll Cardiol. Do not use open or damaged packages. Do not use kinked or damaged devices. Prior to use, please consult device labeling and instructions for use. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. This website is intended for US audience only. After IVUS, the stent was dilated to 3.75 mm. The CAT family of catheters is the foundation of Penumbra's Indigo System. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Otherwise, this could result in degradation of the performance of this equipment. Learn more about Lightning. 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 the Indigo Aspiration System in conjunction with fluoroscopic visualization. The complaint has been evaluated. Figure 1. UPC: Current Stock: This item is out of stock. These pages are not intended for patients or for members of the general public. Contraindications Not for use in the coronaries or the neurovasculature. Saxon RR, Benenati JF, Teigen C, et al. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. BJC Cardiology Equipment is not safe for MR use. UMassMemorial University Campus (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 use in oxygen rich environment. 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. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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. 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. Return all damaged devices and packaging to the manufacturer/ distributor. Brian Kolski, MD sjaymathewsmd@gmail.com Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Aspiration Tubing 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; 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. The canister is intended for single use only. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE.