Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. New Indigo System By Penumbra - Medical Device News Magazine Use prior to the Use By date. Disclosures: None. Equipment is not safe for MR use. (Photo: Business Wire). Semin Dial. Disclosures: None. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System with . PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. Do not use kinked or damaged devices. Warnings/Precautions The canister is intended for single use only. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Do not use kinked or damaged devices. The patients echocardiogram showed normal RV size and function. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Miami Cancer Institute Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Executive Vice Chairman Scan showing preoperative left venous thrombus. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. Figure 1. The system is indicated for the removal of fresh, soft emboli and thrombi . Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. Miami Vascular Specialists Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. A 67-year-old woman with a history of venous thrombus and iliac venous stenting presented with significant recurrent left lower extremity venous thrombus, and the patients symptoms did not significantly improve with anticoagulation alone. Do not re-infuse blood or fluid from the canister back into the patient. Circulation. Indication For Use Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; 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). 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. Associate Professor of Radiology and Surgery The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Venogram showing CAT12 in the CIV. Do not use open or damaged packages. With a device time of only 5 minutes and no use of tPA, the patients symptoms were promptly relieved with no recurring episodes to date. 2023 Bryn Mawr Communications II, LLC. 510-995-2461 Director, Venous Thromboembolic Center and Aortic Center Minneapolis, Minnesota Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. Return all damaged devices and packaging to the manufacturer/distributor. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Use prior to the Use By date. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Interventional Radiology Atrium Health To prevent fire or shock hazard, use a replacement power cord of equal rating. As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. Use only water-based solvents for cleaning. 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. Poor flow through the left TPT. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. Copyright 2022 Penumbra, Inc. All rights reserved. Carrera LA, Reddy R, Pamoukian VN, et al. 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. Only use replacement fuse with correct rating (see Table 1 for fuse rating). (EXTRACT-PE). An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. Using the HTORQ angle on CAT12 to torque the catheter, several passes were made through the affected area, from the left popliteal to the external iliac vein (EIV) and internal iliac vein. Designed for single session arterial thrombus removal, New angled tip shape for maximized clot extraction, Dual pressure sensors for real-time flow monitoring, Large lumen size and circumferential sweep enables maximized thrombus engagement, Multi-pitch hypotube for 1:1 torque transfer and advanced deliverability, Indicated for the treatment of pulmonary embolism. Otherwise, this could result in degradation of the performance of this equipment. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. Catheters & Separators. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. 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. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. A 57-year-old man presented with acute-onset left calf pain for the past 10 days and had recently taken a 4-hour flight. Do not resterilize or reuse. The INDIGO SEPARATOR is not intended for use as a guidewire. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Warnings/Precautions The canister is intended for single use only. Pulmonary embolism (PE) is a condition that occurs when blood clots, typically traveling from the veins in the legs, get caught in the arteries of the lungs. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Precautions The device is intended or single use only. Do not resterilize or reuse. Mean PA pressure at the start of the case was 35 mm Hg. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Indigo System | Penumbra Inc Created with Sketch. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Real-world case examples of Indigo System Lightning 12 Intelligent Aspiration for pulmonary embolism, plus insight into the science behind computer-aided mechanical aspiration and outlooks on PERT development in 2022. 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. Created with Sketch. STRIDE is currently ongoing. Penumbra Announces the European Launch of the Indigo System With Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. CT showed a bilateral PE with right heart strain. CAT12 is . Use prior to the Use By date. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Penumbra (PEN) Launches INDIGO System Lightning 7 in US - Yahoo Finance Figure 2. Disclosures: Consultant to Penumbra, Inc. A 68-year-old man presented with a sudden coolness in both legs after stopping apixaban therapy for 3 days. February 2022. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). With Ramona Gupta, MD, FSIR; Suman M. Wasan, MD, MS, FSVM; and Avianne Bunnell, MD, RPVI, By Andres Schanzer, MD, FACS, and Stphan Haulon, MD, PhD, By Dominique Fabre, MD, PhD; Thomas J. Postiglione, MD; and Stphan Haulon, MD, PhD, Unmet Needs in Ascending and Arch Disease, With Tilo Klbel, MD, PhD, and Joseph Bavaria, MD, With Giovanni Pratesi, MD; Martina Bastianon, MD; Sara Di Gregorio, MD; Gaddiel Mozzetta, MD; and Kimberly Malka, MD, PhD, With Tim Resch, MD, PhD; Sara L. Zettervall, MD, MPH; and Carlos Timaran, MD. Penumbra Augments Vascular Franchise with Latest Indigo System Launch Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510 (k) approval for the new generation of its Indigo Aspiration System, Lightning 12. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy.
Are Clay Hart And Sally Flynn Still Married,
Hollis Company Lawsuit,
Why Did Prince Write Slave'' On His Face,
Cub Cadet Brush Cutter Attachment,
Articles I
