In Stock! US Toll Free: 1-855-331-2436 INTL: +1-727-803-0716 Indigo System Catheter CAT8, CATD, CAT6, CAT5, and CAT3 8 (CAT8, CATD) 6 (CAT6, CAT5) 5 (CAT3) 0.014-0.038: 50-150: Separator-assisted mechanical extraction of thrombus/embolus with Penumbra ENGINE continuous aspiration: Intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and . The pulmonary capillary wedge pressure is 10 mmHg. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 2 to 1. CAT8 was connected to the Penumbra ENGINE, and mechanical aspiration was performed by gently advancing the CAT8 in the P3-TPT, with thrombectomy facilitated by the "back and forth" movement of the Separator 8. Subsequently, a 115 cm, 8F CDT catheter (Indigo CAT8 XTORQ; Penumbra, Alameda, California) was advanced through a 90 cm, 8F Flexor sheath (Cook; Bloomington, Indiana) to perform procedure. 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. 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. System CAT8 TORQ85 catheter (Penumbra, Inc.) and SEP8 separator (Penumbra, Inc.) were then introduced into the venous outflow. This press release features multimedia. We performed over-the-wire thrombectomy of the superficial femoral artery and popliteal artery. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Model #: CAT8TORQ115 CAT8 INDIGO System - Aspiration Catheter - TORQ - 8Fr x 115cm . The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. After just two UPC: Current Stock: 1. Mechanical thrombectomy was performed. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . UPC: Current Stock: This item is out of stock. A 260-cm stiff guidewire was inserted into the pigtail catheter and exchanged for the Indigo System's Aspiration Catheter CAT8 XTORQ. Penumbra System. Model #: IST3 Penumbra Indigo System Aspiration Tubing-285cm . The Separator was used to facilitate clearing of the thrombus from the catheter tip (Figure3). Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Penumbra's Pump MAX™ and patented Separator™ technol-ogy, maintains continuous aspiration and limits clogging of the catheter's tip. Ships Today! SEP8 Separator 8 .072 150 CAT8 SEP6 Separator 6 .055 175 CAT6 SEP5 Separator 5 .045 175 CAT5 SEP3 Separator 3 .028 190 CAT3 SEPD Separator D .072 90 CATD Accessories . 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. The four catheters—CAT3, 5, 6, & 8—are robust, durable, trackable, and suited for the peripheral anatomy. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . We believe this is the first case reporting the use of the Indigo Penumbra CAT8 catheter for removing lead-associated vegetations prior to TLE. Sponsored by Penumbra, Inc. continuous aspiration throughout the system without clogging the catheter's tip. Penumbra Aspiration Pump - Indication For Use Procedures were performed under moderate sedation with intracardiac echo and a steerable guide with a CAT8 Penumbra aspiration catheter. Our gross profit for the year was 60.3% of revenues compared to . Lightning 12 and Separator 12 Now Indicated for Treatment of PE Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo ® Aspiration System, Lightning™ 12. There was partial improvement of flow, but total occlusion remained. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. b Indigo system CAT8 mechanical thrombectomy catheters. Pinterest; CAT8 KIT - Indigo System - Aspiration Catheter 8 and Aspiration Tubing - 8Fr x 85cm Penumbra System) Model #: CAT8STR85KIT OEM: Penumbra System Expiration Date: 2021 Size: 8Fr x 85cm . Any product information appearing below, including the product indication statement, pertains to an in date item only. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. CAT8 INDIGO System - Aspiration Catheter - XTORQ - 8Fr x 115cm Penumbra System. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Suction thrombectomy was performed using the Penumbra CAT8 aspiration catheter via brachial artery access, with multiple passes through the existing SMA stent. $350.00. neurovascular access catheter, used to track the penumbra select catheter and keep it stable while ascending into aortas. Indigo System Catheters. Penumbra, Inc. USA One Penumbra Place Alameda, CA 94502 USA 1.888.272.4606 T 1.510.748.3200 F 1.510.748.3232 order@penumbrainc.com info@penumbrainc.com Penumbra Europe GmbH Am Borsigturm 44 13507 Berlin Germany T +49 30 2005 676-0 F +49 30 2005 676-10 de-order@penumbrainc.com info@penumbrainc.de Penumbra Neuro Australia Pty Ltd The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT . Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Photos are for illustration purposes only and may not depict the exact item. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems A direct-aspiration first-pass technique was performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through . Catheters to the Penumbra Aspiration Pump. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Images provided courtesy of Penumbra Inc. ©2020 . 18th March 2021. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). $350.00) Model #: CAT8XTORQ115 OEM: Penumbra System Expiration Date: 2021 Size: 8Fr x 115cm . PENUMBRA CAT8 INDIGO ASPIRATION CATHETER, TORQ TIP 85CM - EXPIRED 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. Distal OD. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Vascular Thrombectomy. The Swan-Ganz catheter was exchanged over a long V18 wire. Model #: 90183 Trevo XP Provue Retriever - 3mm x 20mm . 3MAX Reperfusion Catheter + Penumbra Hi-Flow Aspiration Tubing + 4.7Fr x .035" x 160cm. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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, durable, and trackable for use in the peripheral anatomy. The patient underwent a thrombectomy procedure at the end of (b)(6) 2016 (exact date unknown) to treat a bilateral deep vein thrombosis (dvt) using an indigo system aspiration catheter 8 (cat8). Distal OD. 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. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Ships Today! Penumbra System. The catheters (CAT3, CAT5, CAT6, CAT8, and CATD) vary in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. About 36% had . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Peripheral Thrombectomy Indigo ® System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo® Aspiration System for aspiration mechanical thrombectomy in patients with . A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Afterwards, an 8F curved sheath (Indigo 8 Torq Tip, ranges 85 to 115 cm) with CAT8 penumbra device will be used to aspirate the thrombus. This range of sizes allows for smaller-diameter catheters to work 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. The proximal and distal venous segments were adequately declotted without the need for further intervention (Figure4). We performed mechanical thrombectomy with a Penumbra CAT8 catheter of the popliteal artery . Add to Cart The item has been added. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Download scientific diagram | Penumbra system—a Penumbra ENGINE™ aspiration source. Penumbra (PEN) to initiate commercialization of RED 62 Reperfusion Catheter post FDA clearance. Model #: CAT8XTORQ115 CAT8 INDIGO System - Aspiration Catheter - XTORQ - 8Fr x 115cm . . The catheter was then retracted in the P2 segment, and the procedure repeated a total of five times. During the procedure, the physician aspirated approximately 1. 4 This single-arm study in 119 patients with submassive PE showed significantly reduced right ventricular-to-left ventricular ratios at 48 hours (0.43 ratio reduction; 95% . 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. This percutaneous system is avail-able in four diameter options (CAT3, CAT5, CAT6, and CAT8) ranging from 3.4 to 8 F and lengths ranging from 85 to 150 cm. OEM: Penumbra System Expiration Date: 2021-2022 Size: 150cm . CAT8 INDIGO System - Aspiration Catheter - XTORQ - 8Fr x 115cm. Add to Cart The item has been added. 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. . The CAT family of catheters is the foundation of Penumbra's Indigo System. $350.00. A 6-F angled-pigtail catheter (Cordis, a Cardinal Health company) was introduced in the main PA, and PAP was measured at 43/16 mmHg (mean, 27 mm Hg). We removed a lot of thrombus. The CAT™8 (size: 8-French/2.67 mm diameter, 85 cm length) is the suction catheter used to remove . This is potentially more effective than diminished syringe-based aspiration. Penumbra's Pump MAX™ and patented Separator™ tech-nology help to maintain continuous aspiration, limiting clogging of the catheter's tip. The CAT8 catheter was delivered into the highest thrombus bur- An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels . 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. A follow up mdr will be submitted upon completion of the device investigation. 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 . o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is . Healthcare company Penumbra announced that its Indigo system CAT RX catheter has achieved the primary endpoint in the Cheetah clinical study. Stryker Neurovascular. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo® System. If the operating physician deems necessary, they will have the option at that point to balloon plasty, stent, or use catheter-directed thrombolysis at this point. number of bacteria on a surface that has not been sterilized. Images provided courtesy of Penumbra Inc. ©2020 . Sign in to add this product to your favorites! CAT8STR85: Penumbra CAT8 Indigo Aspiration Catheter, Straight Tip 85cm. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels . Using the CAT8 and the XTRACT technique, we were able to completely remove all clot from the popliteal artery, but the tibioperoneal trunk was still occluded, so we tele-scoped using the CAT6 (135 cm) coaxially through the CAT8 catheter (Figures 3 and 4). UPC: Current Stock: . reperfusion catheters used for the revascularization of patients with acute ischemic stroke (ex: ACE 60, ACE 64, ACE 68) . Penumbra System. The CAT family of catheters is the foundation of Penumbra's Indigo system. Thrombus was retrieved and a new 7 × 29 VBX stent was placed with good angiographic result. 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 . Penumbra System. A, B: Pulmonary angiography and CT angiography, of a 37-year-old male patient diagnosed with a massive pulmonary embolism, 24-year-old female patient diagnosed with massive pulmonary embolism; C-F: Treated with CAT8 and SEP8 Indigo System ® by PENUMBRA and catheter directed therapy with Pig-tail catheter with an infusion of 1200000.00 UI . $499.00 box of 1 - Penumbra # CAT8TORQ85 - Penumbra CAT8 Indigo Aspiration Catheter, Torq Tip 85cm At her one-month follow-up appointment, the patient reported good overall health and complete . This percutaneous system is available in four diameter options (CAT3, CAT5, CAT6, and CAT8), with lengths ranging from 85 to 150 cm, allowing smaller-diameter catheters to work coaxially through larger- Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Download scientific diagram | Penumbra system—a Penumbra ENGINE™ aspiration source. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. UPC: Current Stock: . Indigo System Catheters. Aspiration Catheters to the Penumbra Aspiration Pump. US Toll Free: 1-855-331-2436 INTL: +1-727-803-0716 Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . CAT8STR85: Penumbra CAT8 Indigo Aspiration Catheter, Straight Tip 85cmIn-Date » Penumbra » Thrombectomy. In Stock! $500.00. • The Indigo CAT8 catheter was connected to the Penumbra ENGINE. Catheters; CAT8 KIT - Indigo System - Aspiration Catheter 8 and Aspiration Tubing - 8Fr x 85cm; Facebook; . . The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. • The Indigo CAT8 catheter was connected to the Penumbra ENGINE. $350.00. b Indigo system CAT8 mechanical thrombectomy catheters. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm. It should be noted that the patient had a steep iliac bifurcation. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. $350.00) Model #: CATD OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 50cm x 4cm . Indigo system Lightning 7. Event Description. Penumbra today announced US commercial availability of the Indigo system Lightning 7. In Stock! Revenue from our neuro business for the full year 2020 was $292.6 million, a decline of 11.8% reported and 12% in constant currency. $499.00 box of 1 - Penumbra # CAT8TORQ85 - Penumbra CAT8 Indigo Aspiration Catheter, Torq Tip 85cm bioburden. Separator 8, 150 cm Length, 0.072 in. The trial has shown the safety and performance of continuous aspiration thrombectomy with Indigo system CAT RX catheter in high-risk patients with acute coronary syndrome. Penumbra introduced the Indigo ® System CAT RX for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. This press release features multimedia. Picture of the Penumbra Indigo® Aspiration System showing the CAT™8, SEP™8, and ENGINE™. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . This allows smaller-diameter catheters to work coaxially through larger-diameter cath- . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. Patients were all deemed high risk for surgical debridement by a CT surgeon and evaluated by an infectious disease consultant. Price: $1,099.00 EACH. Distal OD. In the study, Penumbra's . 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. $599.00 box of 1 - Penumbra # CAT3 - Penumbra Indigo CAT3 Aspiration Catheter 150cm Using the CAT8 and the XTRACT technique, we were able to completely remove all clot from the popliteal artery, but the tibioperoneal trunk was still occluded, so we telescoped using the CAT6 (135 cm) coaxially through the CAT8 catheter (Figure 3 and Figure 4). Quantity: Decrease . The low-profile catheter and Penumbra . Control angiography immediately after thrombectomy demonstrated restored patency . Results: There were no intraprocedural deaths or complications. The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8), a non-penumbra sheath, and a guidewire. K142870 K192981 Materials Materials Biocompatible, commonly utilized for interventional devices SAME plus additional material compositions Coating Hydrophilic SAME The proposed benefits of the newly described technique are the lack of systemic anticoagulation requirement, single and smaller venous access requirement, and greater flexibility in positioning the . 5 liters of blood. 3053. Photo: Courtesy of Business Wire. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm. CAT8XTORQ115: Penumbra CAT8 Indigo Aspiration Catheter, XTorq Tip 115cm. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Repeat angiogram demonstrated patency of flow in the popliteal artery with irregularity and debris in the tibioperoneal trunk. The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Early success with use of the 8F Indigo CAT 8 system (Penumbra, Inc.) for pulmonary thrombectomy prompted the EXTRACT-PE (Evaluating the Safety and Efficacy of the Indigo Aspiration System in Acute Pulmonary Embolism) trial. The Indigo System CAT8 catheter comes in three different tip designs—straight, 45°, 90°—which allows a wide range of rotation. Ships Today! Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. The CAT family of catheters is the foundation of Penumbra's Indigo system. K192981 Page 3 of 9 Catheter CAT8 [Predicate] CAT12 [Subject] 510(k) No.
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