Penumbra Indigo, announced that the CHEETAH clinical study of its Indigo System CAT RX Catheter We opted for aspiration thrombectomy with the Indigo™ System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc. Penumbra’s Indigo Aspiration System (Penumbra Inc. Penumbra’s technology has redefined mechanical thrombectomy of acute arterial occlusions in different vascular beds encountered in my daily practice. , Place Alameda, CA) is a trackable, large-lumen (Indigo System CAT7, 7F) catheter and aspiration system used for aspiration of thromboembolism involving the peripheral venous and arterial systems, as well as pulmonary emboli. 販売名：INDIGOシステム 一般的名称：中心循環系塞栓除去用カテーテル 医療機器承認番号：30500BZI00017000 販売名：Penumbraエンジン 一般的名称：電動式可搬型吸引器 医療機器承認番号：30500BZI00018000 製造等事業者： Penumbra, Inc. 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 Penu bra Aspiration Pump. Individual results may vary depending on patient-specific attributes and other factors. Disclosures: Consultant to Penumbra, Inc. Penumbra's Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. , Alameda, CA, USA) is a suction embolectomy device that was cleared by the Food and Drug Administration for use in acute pulmonary embolism (PE). Sponsored by Penumbra, Inc. Penumbra INDIGO system (Penumbra Inc. Food and Drug Administration 510 (k) clearance for PE in December 2019. Data from the EXRACT-PE trial find the Indigo Aspiration system (Penumbra) is safe and effective for the treatment of pulmonary embolism. (NYSE: PEN), ein internationales Gesundheitsunternehmen, das auf innovative Therapien spezialisiert ist, verkündete, dass sein Indigo A. Ordering Information and venous systems. August 20, 2024—Penumbra, Inc. INDIGO Aspiration Tubing – Indication For Use As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspira- tion Catheters to the Penumbra Aspiration Pump. ) for mechanical thrombectomy of pulmonary embo Abstract Background: The Penumbra Indigo aspiration system (Penumbra Inc. The Indigo System Lightning 12 is the company’s newest generation aspiration system for peripheral thrombectomy. Penumbra, CAT8, Indigo, Aspiration Catheter 8, TORQ tip, 85cm , 8Fr. ) for mechanical thrombectomy of pulmonary embo An 8-F Indigo Aspiration Catheter (CAT8TORQ85) The Penumbra ENGINE provides continuous aspiration (Penumbra, Inc. Penumbra’s Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for the treatment of pulmonary embolism. Prior to use, please refer to the Instructions for Use for Indigo Aspiration System and Penumbra Pump MAX for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. The company stated the study showed that frontline use of Indigo to treat LE-ALI is safe and effective. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Oct 11, 2022 · The CAT family of catheters is the foundation of Penumbra’s Indigo System. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. In a new subgroup analysis of the EXTRACT-PE trial, the Indigo aspiration system (Penumbra) was effective at improving clinical outcomes for submassive pulmonary embolism (PE) patients regardless of emboli location. announced 1-year limb salvage and quality-of-life data from the STRIDE study of the company’s Indigo aspiration system for treatment of patients with lower extremity acute limb ischemia (LE-ALI). Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Cathe-ters 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. With The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI). van den Berg, MD, PhD Head of Service of Interventional Radiology Ospedale Regionale di Lugano Lugano The Indigo System utilizes the Penumbra ENGINE™ aspiration source to deliver nearly pure, continuous vacuum suction to the Indigo System Aspiration Catheters to address emboli and thrombus in vessels of various sizes. ) was introduced over an Amplatz super stiff 260-cm guide-wire (Boston Scientific Corporation). The Indigo System with CAT6 catheter was connected to the Penumbra ENGINE pump system and was used to We then performed balloon angioplasty of the popli-teal, anterior tibial, and peroneal arteries to get the final result (Figure 2). a. 0, current complaints data and physician experience. Perspectives on PE Care Using Penumbra’s Indigo® System With Lightning® Intelligent Aspiration 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. The Penumbra Indigo ® Aspiration System (Penumbra Inc. Penumbra Indigo System is a vascular thrombectomy device for removing emboli and thrombi from peripheral and pulmonary vessels. November 12, 2021 — Penumbra Inc. S. ) at a large tertiary care hospital between January 2019 and April 2023. They feature power aspiration, tip directionality, and separator technology. ), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The Separator device (SEP; Penumbra, Inc. Penumbra Indigo® system to safely remove intracardiac thrombus in a 7-month-old infant with severe immunodeficiency disorder - Volume 34 Issue 9 Indigo Aspiration Tubing – Indication For Use As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspiration Catheters to the Penumbra Pump MAXTM. While this device has proven to be safe in clinical trials, real-world data are minimal. ): Penumbra’s Indigo CAT 8 system is a flexible 8 F aspiration catheter connected to a continuous vacuum system. Lightning Bolt 7 received FDA clearance and became available in March 2023. Indigo Potential Adverse Events The INDIGO Separator may be provided with an introducer and torque device. The catheter’s lumen contains a wire with an olive-shaped distal tip that enhances clot fragmentation and recovery. Using the Lightning 12 and SEP12 (Penumbra, Inc. Penumbra introduced the Indigo System CAT RX for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra’s Indigo® System. Images used with Indigo Aspiration Tubing Penumbra ENGINE aspiration source Penumbra ENGINE Canister The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. The Indigo System enables the removal of emboli and thrombi from vessels of the peripheral arterial system. ) for mechanical thrombectomy of pulmonary embolism (PE). oroscopy. Penumbra社の製品: 血栓切除カテーテル Indigo® に関するすべての情報をご覧ください。価格、見積もり、お近くの販売店を知るにはメーカーまたは本社に直接お問い合わせください。 Penumbra introduced the Indigo System, a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature, in 2014. Thanks to the creation of pulmonary Indigo Aspiration Tubing – Indication For Use As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspira- tion Catheters to the Penumbra Aspiration Pump. , Peripheral Thrombectomy 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. and Asahi Intecc Co. It is part of Penumbra’s Indigo® System with Lightning portfolio, which are the only computer-aided thrombectomy systems currently available in the United States. Recent advances in technology and the increasing awareness on the disease itself have driven the management of this condition toward a more proactive approach. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbr Penumbra’s Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for the treatment of pulmonary embolism. Winners and Losers in the Vascular Arms Race The primary "winner" in this transaction, beyond Penumbra shareholders, appears to be the combined entity’s clinical reach. The Penumbra Indigo aspiration system (Penumbra Inc. Penumbra's peripheral thrombectomy platform, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature Penumbra’s Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for the treatment of pulmonary embolism. Lightning Intelligent Aspiration The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Lightning 12 combines the Indigo System CAT™12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system’s unique clot detection mechanism. The Indigo aspiration system is indicated for use in the peripheral arterial system and the pulmonary arteries, receiving U. The Indigo System CAT3, CAT5, CAT6, CAT8, and CATD are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Safety data from STRIKE-PE Study using Lightning Flash 1. USA One Penumbra Place Alameda, CA 94502 USA 選任製造販売業者：ディーマー Penumbra’s Indigo® Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for the treatment of pulmonary embolism. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is c nnected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump GO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, a Penumbra社の製品: 血栓切除カテーテル Indigo® に関するすべての情報をご覧ください。価格、見積もり、お近くの販売店を知るにはメーカーまたは本社に直接お問い合わせください。 The Penumbra Indigo ® Aspiration System (Penumbra Inc. Compared to Indigo ™ System Lightning ™ 12 Specs & Compatibility Methods: We retrospectively examined the clinical, angiographic, and procedural characteristics, outcomes, and follow-up of patients who underwent mechanical aspiration thrombectomy with the Indigo CAT RX system (Penumbra Inc. b. , CA, USA) is a US FDA-approved large-bore aspiration thrombectomy device for the treatment of pulmonary embolism. 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. ). Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Figure 1. Indigo System Catheters are devices for peripheral mechanical thrombectomy, designed to remove fresh, soft emboli and thrombi from vessels. By acquiring the "Indigo" and "RED" catheter lines, Boston Scientific now possesses the most comprehensive "bag" of products for vascular surgeons and interventional radiologists. The devices are visible under fluoroscopy. ase, the Indigo CAT6 catheter was chosen through angiographic measurements. The Indigo System offers a safe and effective option for such challenging cases. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Acute venous thromboembolic disease carries signifi-cant mortality and morbidity with consequent implica-tions on health economics and quality of life. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Product availability varies by country. It consists of catheters, separators, tubing, aspiration source and canister. This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical pre… Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Purpose: To demonstrate the technical aspects of the novel Penumbra Indigo Lightning Flash System (Penumbra, Inc. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. COURSE OF TREATMENT We performed a transjugular access with a 12-F introducer sheath. In 2014, Penumbra introduced the Indigo System, a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature. Jos C. Lightning Bolt 7 with Bolt Mode. will collaborate to introduce Penumbra's Indigo™ Aspiration System into the Japanese market upon regulatory approval. Recent data has demonstrated improved radiographic end points with low rates of major adverse events in cases of intermediate-risk pulmonary embolism. The Indigo aspiration system (Penumbra) is comprised of the 8-F Indigo aspiration catheter and its associated tubing, pump, and separator (Figure 2). The Indigo® System Lightning™ 12 (Penumbra, Inc. Penumbra, Inc. ) is an intelligent aspiration system powered by the Penumbra ENGINE™ (Figure 1). Penumbra SEP8 Indigo System, Separator 8, Size 150cm, Box of 01 The Penumbra Indigo System Separator is intended for use with our Indigo System’s Continuous Aspiration Mechanical Thrombectomy catheter to aid in the removal of clot from the body. ) helps clear clot at the tip of the catheter and aids in the maceration of thrombus, allowing continuous aspiration, which is a key factor in the management of these critically ill patients. In 2014, Penumbra launched the Indigo System specifically for this application, redefining below-the-knee mechanical thrombectomy. The four catheters—CAT3, 5, 6, & 8—are robust, durable, trackable, and suited for the peripheral anatomy. System Overview A minimally-invasive device, Indigo System enables the restoration of blood flow in such cases a Penumbra’s Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for the treatment of pulmonary embolism. lqhxk, nsgvfa, 8jvbzj, 4zph5u, ohlpa, fhk7j, zdjsp, oivcs, rn13, pxoflk,