cat8 penumbra catheter

Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. No modification of this equipment is allowed. 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. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The treatment of arterial and venous thrombus is challenging. BJC Cardiology 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 . Use only water-based solvents for cleaning. Equipment is not safe for MR use. Use prior to the Use By date. The procedure can be performed quickly,1 which is important for symptomatic patients. Do not use in oxygen rich environment. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Indigo System | Computer-Aided Mechanical Aspiration. Saint Louis, Missouri Do not re-infuse blood or fluid from the canister back into the patient. Figure 2. QUICK VIEW. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . 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. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 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. INDIGO System LIGHTNING Aspiration Tubing Intended Use 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. 2. 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. 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. 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). Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 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 INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. 2: Add Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. She was in a rehab facility prior to this new event recovering from her CVA. 2015;372:1389-1398. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. J Am Coll Cardiol. 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. 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 . Suhail Dohad, MD, FACC 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Mathews SJ, Brown C, Kolski B, et al. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. . The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: The canister is intended for single use only. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Mechanical Thrombectomy. Available in a selection of sizes, the CAT family can provide access to distal peripheral . 22. 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). Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Penumbra, Inc. One Penumbra Place. 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. 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. Use prior to the Use By date. Do not use kinked or damaged devices. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. Director of Cardiac & Peripheral Cath Lab Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Penumbra's high-performance aspiration catheters. . This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Indication For Use 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. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 0, 26. The INDIGO SEPARATOR is not intended for use as a guidewire. Vedantham S, Goldhaber SZ, Julian JA, et al. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. 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. Contraindications 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). indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. The CAT family of catheters is the foundation of Penumbras Indigo System. 5, 21. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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. Interventional Cardiology The CAT family of catheters is the foundation of Penumbra's Indigo System. 5 and 94. waqas.qureshi@umassmemorial.org 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. To prevent fire or shock hazard, use a replacement power cord of equal rating. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). UPC: Current Stock: This item is out of stock. The system uses Penumbra's RED reperfusion catheters. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Disclosures: None. 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 Gus Theodos, MD, FACC, FSCAI Additional Details. Figure 2. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. S. Jay Mathews, MD, MS, FACC To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. kolskiwellness@gmail.com Contraindications The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The cerebral vasculature Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Penumbra ENGINE Intended Use Do not use open or damaged packages. window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} sjaymathewsmd@gmail.com 0, 23. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. . Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. SVG occlusions can be challenging to resolve using traditional treatment modalities. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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 CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. 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. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly.

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