Use prior to the Use By date. Gus Theodos, MD, FACC, FSCAI
Photo: Courtesy of Business Wire. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 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. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Do not use in oxygen rich environment. The low-profile catheter and Penumbra ENGINE are easy to set up and use. 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.
510(k) Premarket Notification - Food And Drug Administration 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 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. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. chronic clot, atherosclerotic plaque) 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. System Chair, Clinical Research
Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Potential Adverse Events The procedure can be performed quickly,1 which is important for symptomatic patients. Potential Adverse Events After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Mechanical Thrombectomy. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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 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. Bradenton Cardiology Center/Manatee Memorial Hospital
3. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration.
Penumbra Cat 8 - IndiaMART Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. sjaymathewsmd@gmail.com
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. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended.
Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed Possible complications include, but are not limited to, the following: Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. No modification of this equipment is allowed. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). 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. 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). PENUMBRA ENGINE Intended Use Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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.
Penumbra Indigo System | Vascular Thrombectomy Director of Cardiac Catheterization Lab, PERT & Structural Heart
Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . The product-specific content of this website is intended for use by healthcare professionals only. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. CAT7 and CAT12 are the next generation of the Indigo System catheters. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Final angiogram after stent placement showing resolution of underlying disease. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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 . window.dataLayer = window.dataLayer || []; Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. 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. 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. Initial angiogram of the right pulmonary artery showing pulmonary embolism. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Brandenton, Florida
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.
US physicians publish "first reported use" of Indigo aspiration system Return all damaged devices and packaging to the manufacturer/distributor. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Final angiogram showing resolution of extensive thrombus burden. SVG occlusions can be challenging to resolve using traditional treatment modalities. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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 INDIGO Aspiration System Intended Use Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Do not reuse. 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. gtag('js', new Date()); function gtag(){dataLayer.push(arguments);} Aspiration Tubing Intended Use 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. Possible complications include, but are not limited to, the following:
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.
Indigo System | Penumbra Inc Warnings The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Distal emboli causing PDA occlusion after manual aspiration. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. 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. 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, durable, and trackable for use in the peripheral anatomy. . 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. Figure 1. Copyright 2023 Penumbra, Inc. All rights reserved. Suhail Dohad, MD, FACC
The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology.
Penumbra System Products - Medical Materials 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. N Engl J Med. There were no cases of 30-day cardiovascular death or post procedural stroke. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. Initial angiography revealed an occlusion of the distal RCA. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Orange, California
Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}.
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 The complaint has been evaluated. The device is intended for single use only. 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. Waqas R. Qureshi, MD, MS
CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . Giri J, Sista AK, Weinberg J, et al. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . 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. The CAT familyof catheters is the foundation of Penumbras Indigo System.
Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. 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). The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Return all damaged devices and packaging to the manufacturer/distributor. Prior to use, please consult device labeling and instructions for use. Copyright 2022 Penumbra, Inc. All rights reserved. gus.theodos@bjc.org; @gtheodosmd
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Do not reuse. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. 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. The means of mains disconnect is to remove the power cord. 22. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 2017;377:2240-2252. Do not use kinked or damaged devices. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Warnings/Precautions Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. 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 .