Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. [email protected] Do not use in an oxygen rich environment. Potential Adverse Events Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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 Use prior to the Use By date. 2. 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 was in a rehab facility prior to this new event recovering from her CVA. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Otherwise, this could result in degradation of the performance of this equipment. Potential Adverse Events Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC If the cause cannot be determined, withdraw the device or system as a unit. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. LIGHTNING Aspiration Tubing Indication for Use 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. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. 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). Copyright 2022 Penumbra, Inc. All rights reserved. N Engl J Med. 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. The product-specific content of this website is intended for use by healthcare professionals only. window.dataLayer = window.dataLayer || []; After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Sista A. Indigo aspiration system for acute pulmonary embolism. Penumbra System Products - Medical Materials Categories. Figure 2. 8: Add BMK6F95M-NE . Figure 3. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . The procedure can be performed quickly,1 which is important for symptomatic patients. INDIGO System LIGHTNING Aspiration Tubing Intended Use Use only waterbased solvents for cleaning. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Further evaluation of the returned device revealed kinks in the catheter shaft. The means of mains disconnect is to remove the power cord. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Penumbra's Newest Generation of Indigo Aspiration System Receives FDA 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 Aspiration Pump: Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Figure 1. Orange, California Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 0 cm from the hub. 5, 21. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Cedars Sinai Medical Center Catheters & Separators. Mechanical thrombectomy was performed. 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 . INDIGO Aspiration Tubing: 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. Use prior to the Use By date. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. S. Jay Mathews, MD, MS, FACC Penumbra, Inc. One Penumbra Place. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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). Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 0, 26. 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. PDF May 15, 2018 - Food And Drug Administration Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Next Article CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Indigo System | Computer-Aided Mechanical Aspiration. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX 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; Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. 510 (k) Number. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION . 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. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. University of Massachusetts Medical School 2018;29:92-100. Medical Director, Aortic Disease and Ischemic Limb Disease Learn more about Lightning. Indication For Use Flow through left circumflex artery post-CAT RX. 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 provide access to distal peripheral vessels of the upper and lower . Gus Theodos, MD, FACC, FSCAI Do not use kinked or damaged devices. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 PENUMBRA: CAT3 - westcmr.com Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). UMassMemorial University Campus The CAT familyof catheters is the foundation of Penumbras Indigo System. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. 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, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Warnings/Precautions The canister is intended for single use only. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Warnings 1. St. Joseph Hospital Potential Adverse Events 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 pages are not intended for patients or for members of the general public. 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 The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . The complaint has been evaluated. 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. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Copyright 2022 Penumbra, Inc. All rights reserved. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Potential Adverse Events Related Items. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Penumbra Announces U.S. Commercial Availability of INDIGO System Penumbra ENGINE Intended Use 0 cm from the distal tip. No conversations found. Use prior to the Use By date. Maintain a constant infusion of appropriate flush solution. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Do not use open or damaged packages. 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. 510(k) Premarket Notification - Food And Drug Administration Do not re-infuse blood or fluid from the canister back into the patient. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. These pages are not intended for patients or for members of the general public. The CAT family of catheters is the foundation of Penumbra's Indigo system. Precautions We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Indigo System - Vascupedia PENUMBRA ENGINE Intended Use Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary $399.00 EACH. The Indigo System and CAT8 - Endovascular Today Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. 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. PENUMBRA: SEP8 - Westcmr.com Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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 Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Initial angiogram showing high thrombus burden in the RCA. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The procedure was completed with the same catheter. 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. Return all damaged devices and packaging to the manufacturer/distributor. It will reduce the service life of the PENUMBRA ENGINE. Do not use open or damaged packages. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. If the cause cannot be determined, withdraw the device or system as a unit.
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