cat8 penumbra catheter

Prior to use, please consult device labeling and instructions for use. This website is intended for US audience only. Gus Theodos, MD, FACC, FSCAI 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. Indigo Aspiration System Intended Use Contraindications There are no known contraindications. 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 product-specific content of this website is intended for use by healthcare professionals only. Indication For Use Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Orange, California Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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 . If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. 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. No modification of this equipment is allowed. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Do not reuse. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Use only water-based solvents for cleaning. 5, 21. Copyright 2022 Penumbra, Inc. All rights reserved. TIMI 3 flow was achieved in 88% of cases. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). This press release features multimedia. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. CAT8XTORQ115KIT-NS. This website is intended for US audience only. There are no contraindications. The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics . . Use prior to the Use By date. Penumbra ENGINE Intended Use Equipment is not safe for MR use. function gtag(){dataLayer.push(arguments);} This is potentially more effective than diminished syringe-based aspiration. 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. Circulation. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Alameda, CA 94502. INDIGO Aspiration System Intended Use The means of mains disconnect is to remove the power cord. Do not use kinked or damaged devices. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. This content is not intended to offer professional medical advice. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. 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 Computer-Aided Aspiration comes packaged with CAT7 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. 510 (k) Number. 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. The complaint indicated that the cat8 was kinked during the procedure. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Created with Sketch. Mathews SJ, Brown C, Kolski B, et al. Sista A. Indigo aspiration system for acute pulmonary embolism. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 These pages are not intended for patients or for members of the general public. Control angiography immediately after thrombectomy demonstrated restored patency . 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. Do not re-infuse blood or fluid from the canister back into the patient. CAT7 and CAT12 are the next generation of the Indigo System catheters. 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. PENUMBRA ENGINE Intended Use Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Figure 1. Do not use kinked or damaged devices. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. University of Massachusetts Medical School 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. Contraindications There are no contraindications. 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. UPC: Current Stock: . The cerebral vasculature The product-specific content of this website is intended for use by healthcare professionals only. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 0 cm from the distal tip. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. The results may vary depending on a variety of patient specific attributes. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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 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. Jawairia Sahar K. Mirza, MBBS There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Contraindications 0, 23. N Engl J Med. 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. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . 5 and 94. 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. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. QUICK VIEW. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Figure 2. 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.

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