Director of Cardiac Catheterization Lab, PERT & Structural Heart
The treatment of arterial and venous thrombus is challenging. Warnings Gus Theodos, MD, FACC, FSCAI
Do not reuse. Photo: Courtesy of Business Wire. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Figure 1. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Return all damaged devices and packaging to the manufacturer/distributor. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Penumbra Aspiration Pump: Do not use open or damaged packages. Do not use kinked or damaged devices. 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 newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics . BJC Cardiology
These types of burns heal withing 5 or 6 days without permanent scarring. 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. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Catheters & Separators. Cedars Sinai Medical Center
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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not resterilize or reuse. Precautions The device is intended for single use only. Disclosures: None. Otherwise, this could result in degradation of the performance of this equipment. 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. 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. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. Do not use in an oxygen rich environment. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The removal of fibrous, adherent or calcified material (e.g. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 22. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 8: Add BMK6F95M-NE . The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Final angiogram showing resolution of extensive thrombus burden. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use 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. suhail.dohad@cshs.org
The low-profile catheter and Penumbra . The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . 0, 23. 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. The device is intended for single use only. There were no cases of 30-day cardiovascular death or post procedural stroke. 5, 19. Contraindications There are no known contraindications. 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. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. There are no contraindications. Disclosures: None. UPC: Current Stock: This item is out of stock. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Figure 3. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. INDIGO Aspiration System Intended Use window.dataLayer = window.dataLayer || []; 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. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Smidt Heart institute
The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Saxon RR, Benenati JF, Teigen C, et al. Figure 3. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). 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. UMassMemorial University Campus
The CAT family of catheters is the foundation of Penumbras Indigo System. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Figure 2. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 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. Indication For Use Aspiration Tubing Intended Use CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). 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. Kingsport, Tennessee
Sista A. Indigo aspiration system for acute pulmonary embolism. PENUMBRA ENGINE Indication for Use excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Do not use kinked or damaged devices. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. The canister is intended for single use only. Penumbra's not relying on software alone. Final angiographic result of SVG. 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. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. . Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. 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. 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. sjaymathewsmd@gmail.com
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. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Do not use open or damaged packages. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. CAT RX has allowed us to rethink how we approach these occluded SVGs. K180412. 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 . Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. This is potentially more effective than diminished syringe-based aspiration. Indigo System CAT RX tracking through the distal posterior tibial artery. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Return all damaged devices and packaging to the manufacturer/distributor. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. This content is not intended to offer professional medical advice. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. 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. 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. Waqas R. Qureshi, MD, MS
Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. 2018;29:92-100. Potential Adverse Events 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. Contraindications Categories. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Use only waterbased solvents for cleaning. Alameda, CA 94502. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy.