Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Prior to use, please consult device labeling and instructions for use. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Kingsport, Tennessee Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. The INDIGO SEPARATOR is not intended for use as a guidewire. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. Do not use open or damaged packages. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Swan-Ganz catheter was exchanged over a long V18 wire. 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. Indication For 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. Mathews SJ, Brown C, Kolski B, et al. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. 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. Otherwise, this could result in degradation of the performance of this equipment. Jolly SS, Cairns JA, Yusuf S, et al. 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). Figure 3. Equipment is not safe for MR use. 1. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . The pulmonary capillary wedge pressure is 10 mmHg. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 2023 Bryn Mawr Communications II, LLC. Catheters & Separators. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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 . These types of burns heal withing 5 or 6 days without permanent scarring. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. function gtag(){dataLayer.push(arguments);} 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. Potential Adverse Events The cat8 was kinked approximately 69. 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; 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. UMassMemorial University Campus . CAT RX has allowed us to rethink how we approach these occluded SVGs. She was in a rehab facility prior to this new event recovering from her CVA. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Lightning Flash: The Most Powerful and Advanced Mechanical MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). 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. 0, and 37. How Penumbra's smart-sucking algorithms and catheters speed up clot Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. S. Jay Mathews, MD, MS, FACC Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. There were no cases of 30-day cardiovascular death or post procedural stroke. Figure 2. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. Categories. INDIGO Aspiration System Intended Use 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. gus.theodos@bjc.org; @gtheodosmd Do not use open or damaged packages. 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; and Suhail Dohad, MD, FACC. Penumbra System Products - Medical Materials The Penumbra ENGINE 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. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Potential Adverse Events Disclosures: None. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. System Chair, Clinical Research Figure 1. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 22. 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: 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. UPC: Current Stock: This item is out of stock. 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. Order Qty. PENUMBRA: CAT6 - WestCMR Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. The product-specific content of this website is intended for use by healthcare professionals only. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. window.dataLayer = window.dataLayer || []; After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. Figure 2. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Lightning comes packaged with the Indigo CAT7 or CAT12. Maintain a constant infusion of appropriate flush solution. Mechanical thrombectomy was performed. Figure 2. Photo: Courtesy of Business Wire. . CAT RX is an essential tool in our percutaneous coronary armamentarium. If the cause cannot be determined, withdraw the device or system as a unit. The treatment of arterial and venous thrombus is challenging. Do not use kinked or damaged devices. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Waqas R. Qureshi, MD, MS 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. TIMI 3 flow was achieved in 88% of cases. 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. Randomized trial of primary PCI with or without routine manual thrombectomy. Vedantham S, Goldhaber SZ, Julian JA, et al. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. This website is intended for US audience only. 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. Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The complaint has been evaluated. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Bradenton Cardiology Center/Manatee Memorial Hospital With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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. Figure 3. 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. Not for use in the coronaries or the neurovasculature. Penumbra Augments Vascular Franchise with Latest Indigo System Launch If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. 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 INDIGO Aspiration Tubing: Indigo System CAT RX tracking through the distal posterior tibial artery. This press release features multimedia. N Engl J Med. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. 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 .
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