Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 3. Learn more about Lightning. 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. Distal posterior tibial artery emboli occlusion. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Precautions Return all damaged devices and packaging to the manufacturer/ distributor. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. Return all damaged devices and packaging to the manufacturer/distributor. 2019;140:e774-e801. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. Do not use open or damaged packages. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. 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. 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. INDIGO Aspiration System Indication for Use 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 the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Precautions The device is intended for single use only. Penumbra ENGINE Intended Use 2015;372:1389-1398. Distal emboli causing PDA occlusion after manual aspiration. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. 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. This website is intended for US audience only. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 2. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Figure 2. These pages are not intended for patients or for members of the general public. Indigo System CAT RX | Penumbra Inc Director of Cardiac Catheterization Lab, PERT & Structural Heart Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC 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. 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. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use prior to the Use By date. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. The CAT family of catheters is the foundation of Penumbra's Indigo system. Final angiogram showing resolution of extensive thrombus burden. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. 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. Further evaluation of the returned device revealed kinks in the catheter shaft. Do not use open or damaged packages. Use prior to the Use By date. 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; There was partial improvement of flow, but total occlusion remained. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems 5 and 94. Figure 2. The complaint indicated that the cat8 was kinked during the procedure. Orange, California Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart If repositioning of the Indigo CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Penumbra Aspiration Pump: UMassMemorial University Campus The device is intended for single use only. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. PENUMBRA: SEP8 - Westcmr.com In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Saint Louis, Missouri Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 (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. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Do not block bottom or back air vents. PDF May 15, 2018 - Food And Drug Administration 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. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. J Am Coll Cardiol. To prevent fire or shock hazard, use a replacement power cord of equal rating. Suhail Dohad, MD, FACC Worcester, Massachusetts Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. The patient remained on cangrelor with no need for tirofiban. The product-specific content of this website is intended for use by healthcare professionals only. Warnings 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. 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. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The low-profile catheter and Penumbra ENGINE are easy to set up and use. No conversations found. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. 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 was in a rehab facility prior to this new event recovering from her CVA. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Penumbra System Products - Medical Materials Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 2. Catheters & Separators. 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. Disclosures: None. 5, 21. 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. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Use prior to the Use By date. 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. 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 thrombectomy continues to have clinical benefit in modern cardiac catherization . 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 CAT family of catheters is the foundation of Penumbra's Indigo System. Indication For Use Do not use kinked or damaged devices. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Warnings/Precautions Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. 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. IN-DATE. gtag('js', new Date()); function gtag(){dataLayer.push(arguments);} The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Penumbra's not relying on software alone. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Penumbra Augments Vascular Franchise with Latest Indigo System Launch At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. 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. Do not block bottom air vents. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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 INDIGO SEPARATOR is not intended for use as a guidewire. Vedantham S, Goldhaber SZ, Julian JA, et al. 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. 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 the PENUMBRA ENGINE. 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. Otherwise, this could result in degradation of the performance of this equipment. Gus Theodos, MD, FACC, FSCAI Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. There were no cases of 30-day cardiovascular death or post procedural stroke. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 8: Add BMK6F95M-NE . CAT8XTORQ115KIT-NS. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Indication For Use Initial angiogram showing high thrombus burden in the RCA. Contraindications There are no known contraindications. 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 combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. 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. It will reduce service life of the Penumbra ENGINE. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. Disclosures: None. PENUMBRA: CAT6 - WestCMR The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. 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 Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Penumbra Announces U.S. Commercial Availability of INDIGO System MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION UPC: Current Stock: . If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Learn more about Lightning. INDIGO Aspiration Catheters and Separators: Indigo System - Vascupedia 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). Return all damaged devices and packaging to the manufacturer/distributor. St. Joseph Hospital She had acute tubular necrosis with minimal urine output at the time of transfer. 22. 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. Smidt Heart institute The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Do not use in oxygen rich environment. The device is intended for single use only. These pages are not intended for patients or for members of the general public. Warnings . 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).
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