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When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. This is potentially more effective than diminished syringe-based aspiration. 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. 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. CAT RX is an essential tool in our percutaneous coronary armamentarium. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. chronic clot, atherosclerotic plaque) Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. After IVUS, the stent was dilated to 3.75 mm. Indigo Aspiration System Intended Use No modification of this equipment is allowed. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The results may vary depending on a variety of patient specific attributes. Sista A. Indigo aspiration system for acute pulmonary embolism. Initial angiography revealed an occlusion of the distal RCA. LIGHTNING Aspiration Tubing Indication for Use The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . 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. It will reduce service life of the Penumbra ENGINE. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Contraindications There are no known contraindications. Contraindications Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. She was in a rehab facility prior to this new event recovering from her CVA. 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. Indication For Use Return all damaged devices and packaging to the manufacturer/distributor. Precautions The device is intended for single use only. The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. This content is not intended to offer professional medical advice. Do not use open or damaged packages. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indigo System | Computer-Aided Mechanical Aspiration. 2: Add Chris Metzger, MD Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The INDIGO SEPARATOR is not intended for use as a guidewire. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. Mathews SJ, Brown C, Kolski B, et al. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. The removal of fibrous, adherent or calcified material (e.g. N Engl J Med. 2. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. 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. CAT RX has allowed us to rethink how we approach these occluded SVGs. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. The Indigo System utilises the Penumbra ENGINE aspiration 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Figure 2. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Return all damaged devices and packaging to the manufacturer/distributor. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. INDIGO Aspiration Catheters and Separators: After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . The INDIGO SEPARATOR is not intended for use as a guidewire. Photo: Courtesy of Business Wire. These pages are not intended for patients or for members of the general public. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. function gtag(){dataLayer.push(arguments);} 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 complaint indicated that the cat8 was kinked during the procedure. 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 . Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. 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 . UPC: Current Stock: . Do not use open or damaged packages. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Precautions 2017;377:2240-2252. This website is intended for US audience only. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Cedars Sinai Medical Center Orange, California Otherwise, this could result in degradation of the performance of this equipment. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Do not use open or damaged packages. 3. 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. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Use only waterbased solvents for cleaning. 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. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Initial angiogram showing high thrombus burden in the left circumflex artery. 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. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Distal OD. 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. Applicant. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Precautions S. Jay Mathews, MD, MS, FACC Units in stock: 1. 510 (k) Number. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: 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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cat8 penumbra catheter