Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Initial angiogram showing high thrombus burden in the left circumflex artery. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Mathews SJ, Brown C, Kolski B, et al. 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. Next Article INDIGO Aspiration System Intended Use The pulmonary capillary wedge pressure is 10 mmHg. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm Prior to use, please consult device labeling and instructions for use. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization Penumbra ENGINE Intended Use A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. INDIGO Aspiration System Intended Use After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. 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. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. Return all damaged devices and packaging to the manufacturer/ distributor. Possible complications include, but are not limited to, the following: Otherwise, this could result in degradation of the performance of this equipment. The Indigo Aspiration System is contraindicated in: Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. window.dataLayer = window.dataLayer || []; Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. Use only waterbased solvents for cleaning. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. . Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. If the cause cannot be determined, withdraw the device or system as a unit. Contraindications 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. PDF May 15, 2018 - Food And Drug Administration Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. The product-specific content of this website is intended for use by healthcare professionals only. 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. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 8: Add BMK6F95M-NE . No conversations found. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. These types of burns heal withing 5 or 6 days without permanent scarring. J Am Coll Cardiol. Distal posterior tibial artery emboli occlusion. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. The complaint has been evaluated. Maintain a constant infusion of appropriate flush solution. 1. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. 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. CAT8XTORQ115KIT-NS. This content is not intended to offer professional medical advice. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 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. . 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). function gtag(){dataLayer.push(arguments);} There were no cases of 30-day cardiovascular death or post procedural stroke. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use kinked or damaged devices. function gtag(){dataLayer.push(arguments);} 510(k) Premarket Notification - Food And Drug Administration Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. skin is red but turns white when pressed Potential Adverse Events 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. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. gus.theodos@bjc.org; @gtheodosmd 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. 2018;29:92-100. System Chair, Clinical Research 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. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. 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. 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. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . . Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. The CAT family of catheters is the foundation of Penumbra's Indigo System. Separator 8, 150 cm Length, 0.072 in. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Initial angiogram showing high thrombus burden in the RCA. Penumbra Cat 8 - IndiaMART waqas.qureshi@umassmemorial.org Lightning comes packaged with the Indigo CAT7 or CAT12. 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. How Penumbra's smart-sucking algorithms and catheters speed up clot 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. gtag('js', new Date()); CAT7 and CAT12 are the next generation of the Indigo System Catheters. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Contraindications There are no known contraindications. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. UMassMemorial University Campus Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Possible complications include, but are not limited to, the following: Gus Theodos, MD, FACC, FSCAI To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. 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. INDIGO Aspiration Catheters and Separators: Do not re-infuse blood or fluid from the canister back into the patient. Precautions The device is intended for single use only. Use prior to the Use By date. The CAT family of catheters is the foundation of Penumbra's Indigo system. Use only water-based solvents for cleaning. 2018;72:1589-1596. St. Joseph Hospital Return all damaged devices and packaging to the manufacturer/distributor. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Do not resterilize or reuse. left-arrow Latest System Designed for Single Session Arterial Thrombus Removal News Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary 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).