Waqas R. Qureshi, MD, MS The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. 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 patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Initial angiography revealed an occlusion of the distal RCA. Contraindications There are no contraindications. If the cause cannot be determined, withdraw the device or system as a unit. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. 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. Precautions The device is intended for single use only. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Copyright 2022 Penumbra, Inc. All rights reserved. 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. function gtag(){dataLayer.push(arguments);} Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. 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. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Additional Details. She had acute tubular necrosis with minimal urine output at the time of transfer. 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. Randomized trial of primary PCI with or without routine manual thrombectomy. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Do not resterilize or reuse. Mathews SJ, Brown C, Kolski B, et al. Final angiogram showing resolution of extensive thrombus burden. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Contraindications There are no known contraindications. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The penumbra cat8 indigo system (cat8) was kinked approximately 4. She was in a rehab facility prior to this new event recovering from her CVA. The Indigo System utilizes the Penumbra ENGINEaspiration 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. LIGHTNING Aspiration Tubing Indication for Use Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Los Angeles, California 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. Do not use kinked or damaged devices. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. This is potentially more effective than diminished syringe-based aspiration. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not resterilize or reuse. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . 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. 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). Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Do not block bottom or back air vents. The product-specific content of this website is intended for use by healthcare professionals only. The Indigo System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. If the cause cannot be determined, withdraw the device or system as a unit. 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 patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Contraindications Jawairia Sahar K. Mirza, MBBS CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Catheters & Separators. Potential Adverse Events Conclusions: evaluation of the cat8 revealed that the device was fractured. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. No modification of this equipment is allowed. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 1. 1. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. The CAT familyof catheters is the foundation of Penumbras Indigo System. The removal of fibrous, adherent or calcified material (e.g. 2: Add 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. Do not resterilize or reuse. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Contraindications Not for use in the coronaries or the neurovasculature. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. CAT8XTORQ115KIT-NS. The Swan-Ganz catheter was exchanged over a long V18 wire. Use prior to the Use By date. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. The product-specific content of this website is intended for use by healthcare professionals only. 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. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. To prevent fire or shock hazard, use a replacement power cord of equal rating. Return all damaged devices and packaging to the manufacturer/ distributor. Penumbra ENGINE Intended Use The procedure was completed with the same catheter. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Chris Metzger, MD The CAT family of catheters is the foundation of Penumbras Indigo System. 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. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Possible complications include, but are not limited to, the following: The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. There are no contraindications. Do not use open or damaged packages. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. These pages are not intended for patients or for members of the general public. Throughout each case, Lightning provides procedural feedback via audiovisual cues. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. Mechanical Thrombectomy. 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.
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