cat8 penumbra catheter
Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Mechanical Thrombectomy. Orange, California Do not use open or damaged packages. Lightning comes packaged with the Indigo CAT7 or CAT12. Indication For Use Use prior to the Use By date. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. 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. Flow through left circumflex artery post-CAT RX. 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 . Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). After IVUS, the stent was dilated to 3.75 mm. No modification of this equipment is allowed. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Precautions Disclosures: None. Created with Sketch. Potential Adverse Events J Am Coll Cardiol. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. left-arrow Return all damaged devices and packaging to the manufacturer/ distributor. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Figure 2. Otherwise, this could result in degradation of the performance of this equipment. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm skin is red but turns white when pressed The treatment of arterial and venous thrombus is challenging. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. It will reduce service life of the Penumbra ENGINE. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. The CAT family of catheters is the foundation of Penumbra's Indigo system. Figure 2. Figure 3. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). Otherwise, this could result in degradation of the performance of this equipment. Do not use in an oxygen rich environment. PENUMBRA: CAT3 - westcmr.com 2019;140:e774-e801. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Units in stock: 1. Penumbra, Inc. One Penumbra Place. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 3. Related Items. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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). Return all damaged devices and packaging to the manufacturer/distributor. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. This is potentially more effective than diminished syringe-based aspiration. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Cedars Sinai Medical Center Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Learn more about Lightning. Do not resterilize or reuse. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Brian Kolski, MD The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. gtag('js', new Date()); Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. 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. 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. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq 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. Penumbra's not relying on software alone. The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. Photo: Courtesy of Business Wire. 5, 19. Director of Cardiac & Peripheral Cath Lab 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 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. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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). BJC Cardiology Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Return all damaged devices and packaging to the manufacturer/distributor. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. TIMI 3 flow was achieved in 88% of cases. Kingsport, Tennessee 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. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed 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. 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. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Otherwise, this could result in degradation of the performance of this equipment. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . . 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Figure 2. The device is intended for single use only. 510 (k) Number. 0, and 37. 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. Jawairia Sahar K. Mirza, MBBS 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. If the cause cannot be determined, withdraw the device or system as a unit. 2: Add Indication For Use The healthcare firm said that the Indigo CAT RX Aspiration Catheters . The CAT family of catheters is the foundation of Penumbra's Indigo System. suhail.dohad@cshs.org Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Do not use kinked or damaged devices. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. This content is not intended to offer professional medical advice. 1. Return all damaged devices and packaging to the manufacturer/distributor. The procedure was completed with the same catheter. window.dataLayer = window.dataLayer || []; Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Maintain a constant infusion of appropriate flush solution. This content is not intended to offer professional medical advice. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Penumbra Aspiration Pump: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Conclusions: evaluation of the cat8 revealed that the device was fractured. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. Penumbra Announces U.S. Commercial Availability of INDIGO System Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. INDIGO Aspiration System Intended Use Do not use kinked or damaged devices. 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 .