Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Latest System Designed for Single Session Arterial Thrombus Removal News Contraindications There are no known contraindications. 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. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. 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. The Swan-Ganz catheter was exchanged over a long V18 wire. Sista A. Indigo aspiration system for acute pulmonary embolism. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The patient remained on cangrelor with no need for tirofiban. 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. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. 1. 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. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Figure 2. Use prior to the Use By date. Figure 3. Do not use kinked or damaged devices. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Do not block bottom or back air vents. Figure 3. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Prior to use, please consult device labeling and instructions for use. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 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. 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. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Jawairia Sahar K. Mirza, MBBS Do not use kinked or damaged devices. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. 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. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Distal emboli causing PDA occlusion after manual aspiration. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. 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. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Orange, California 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). Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Penumbra ENGINE Intended Use 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. 0 cm from the hub. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Indigo System CAT RX tracking through the distal posterior tibial artery. Figure 2. Potential Adverse Events 3. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. These pages are not intended for patients or for members of the general public. CAT8XTORQ115KIT-NS. PENUMBRA ENGINE Intended Use Throughout each case, Lightning provides procedural feedback via audio visual cues. 510 (k) Number. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. 2. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Use prior to the Use By date. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. function gtag(){dataLayer.push(arguments);} If the cause cannot be determined, withdraw the device or system as a unit. Do not reuse. CAT7 and CAT12 are the next generation of the Indigo System catheters. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. She had acute tubular necrosis with minimal urine output at the time of transfer. 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. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. These pages are not intended for patients or for members of the general public. . QUICK VIEW. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Otherwise, this could result in degradation of the performance of this equipment. Figure 1. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 2017;377:2240-2252. Los Angeles, California The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 2019;140:e774-e801. 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 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. 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. Warnings/Precautions Brian Kolski, MD Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Contraindications Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. [email protected] If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Contraindications There are no known contraindications. Cedars Sinai Medical Center 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. 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. 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. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. Distal OD. Photo: Courtesy of Business Wire. Saint Louis, Missouri Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Waqas R. Qureshi, MD, MS Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Copyright 2022 Penumbra, Inc. All rights reserved. Units in stock: 1. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: function gtag(){dataLayer.push(arguments);} Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. The pulmonary capillary wedge pressure is 10 mmHg. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. 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. Director, Structural Heart INDIGO Aspiration Tubing: Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Potential Adverse Events 0, 24. 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. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. 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. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Contraindications Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 2015;372:1389-1398. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Figure 3. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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.
cat8 penumbra catheter
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