cat8 penumbra catheter

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. 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 . window.dataLayer = window.dataLayer || []; If the cause cannot be determined, withdraw the device or system as a unit. Indigo Separator 4 is intended to be used with Indigo CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. The penumbra cat8 indigo system (cat8) was kinked approximately 4. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. 2017;377:2240-2252. skin is red but turns white when pressed 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. 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. 8: Add BMK6F95M-NE . 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. 0, 26. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Chris Metzger, MD The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Vedantham S, Goldhaber SZ, Julian JA, et al. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. Figure 1. Learn more about Lightning. 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. Saxon RR, Benenati JF, Teigen C, et al. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). 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. Categories. Do not use kinked or damaged devices. 3. Distal posterior tibial artery emboli occlusion. Do not reuse. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). The means of mains disconnect is to remove the power cord. Otherwise, this could result in degradation of the performance of this equipment. The INDIGO Aspiration System 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. 5 and 94. These pages are not intended for patients or for members of the general public. Final angiogram with complete TIMI 3 flow after the use of CAT RX. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Catheters & Separators. 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 patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 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. Director of Cardiac & Peripheral Cath Lab Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Copyright 2022 Penumbra, Inc. All rights reserved. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Rethinking Thrombus Removal With the Indigo System: Introducing The CAT family of catheters is the foundation of Penumbra's Indigo System. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Prior to use, please consult device labeling and instructions for use. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Penumbra ENGINE Intended Use Do not re-infuse blood or fluid from the canister back into the patient. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Jolly SS, Cairns JA, Yusuf S, et al. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. 0 cm from the distal tip. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Figure 3. 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. INDIGO Aspiration Catheters and Separators: The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Indigo Aspiration System Intended Use To prevent fire or shock hazard, use a replacement power cord of equal rating. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. 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. Figure 2. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. Disclosures: None. UMassMemorial University Campus SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Otherwise, this could result in degradation of the performance of this equipment. Potential Adverse Events The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. Maintain a constant infusion of appropriate flush solution. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The CAT family of catheters is the foundation of Penumbra's Indigo system. QUICK VIEW. function gtag(){dataLayer.push(arguments);} 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Penumbra ENGINE Intended Use Indigo System Catheters & Separators | Penumbra Inc Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. kolskiwellness@gmail.com 2018;72:1589-1596. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. How Penumbra's smart-sucking algorithms and catheters speed up clot 2. The product-specific content of this website is intended for use by healthcare professionals only. Director of Cardiac Catheterization Lab, PERT & Structural Heart 0, 23. This content is not intended to offer professional medical advice. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. 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 . The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Do not resterilize or reuse. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Do not use open or damaged packages. Copyright 2022 Penumbra, Inc. All rights reserved. The CAT familyof catheters is the foundation of Penumbras Indigo System. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. These pages are not intended for patients or for members of the general public. Created with Sketch. Do not use kinked or damaged devices. St. Joseph Hospital Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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.