Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 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. Warnings These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. The Indigo Aspiration System is contraindicated in: INDIGO Aspiration System Intended Use Do not use in oxygen rich environment. If repositioning of the Indigo CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Do not use in an oxygen rich environment. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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 Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Prior to use, please consult device labeling and instructions for use. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Return all damaged devices and packaging to the manufacturer/distributor. Director of Cardiac Catheterization Lab, PERT & Structural Heart
The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). All Rights Reserved Privacy Policy, With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; Suhail Dohad, MD, FACC. 1. Contraindications There are no known contraindications. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 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 the PENUMBRA ENGINE. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 0 cm from the hub. function gtag(){dataLayer.push(arguments);} Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Use prior to the Use By date. Gus Theodos, MD, FACC, FSCAI
The Swan-Ganz catheter was exchanged over a long V18 wire. Do not reuse. Separator 8, 150 cm Length, 0.072 in. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems . 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). The CAT family of catheters is the foundation of Penumbra's Indigo system. 5, 21. The INDIGO Aspiration System 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. 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. 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. Order Qty. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Penumbra's not relying on software alone. Potential Adverse Events University of Massachusetts Medical School
The CAT familyof catheters is the foundation of Penumbras Indigo System. 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. INDIGO Aspiration Catheters and Separators: 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are 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. 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. Final angiogram showing resolution of extensive thrombus burden. SVG occlusions can be challenging to resolve using traditional treatment modalities. . Do not re-infuse blood or fluid from the canister back into the patient. Indigo System CAT RX tracking through the distal posterior tibial artery. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Disclosures: None. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Additional Details. . PENUMBRA ENGINE Indication for Use 5 and 94. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The patient remained on cangrelor with no need for tirofiban. Kingsport, Tennessee
She was in a rehab facility prior to this new event recovering from her CVA. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Initial angiography revealed an occlusion of the distal RCA. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . It will reduce service life of the Penumbra ENGINE. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. 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. System Chair, Clinical Research
Only use replacement fuse with correct rating (see Table 1 for fuse rating). 2. BJC Cardiology
S. Jay Mathews, MD, MS, FACC
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. Device Name. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 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. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. 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). The pain became more intense and constant, so he presented to the ED. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. There were no cases of 30-day cardiovascular death or post procedural stroke. Lightning comes packaged with the Indigo CAT7 or CAT12. INDIGO System LIGHTNING Aspiration Tubing Intended Use Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Figure 2. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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 following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. UMassMemorial University Campus
Aspiration Tubing Intended Use 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). 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. Figure 2. Do not use kinked or damaged devices. She had acute tubular necrosis with minimal urine output at the time of transfer. Do not use kinked or damaged devices. Potential Adverse Events The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. 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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