Aspiration thrombectomy for acute iliofemoral or central deep venous thrombosis. Abbott Laboratories ABT recently announced the acquisition of Walk Vascular, LLC -- a commercial-stage medical device company with a minimally-invasive mechanical aspiration thrombectomy system. Coronary, pulmonary, and neurovasculature. The JETi AIO Peripheral Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. According to Walk Vascular, the Jeti thrombectomy system employs an internal jet and is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. The innovative JETi systems are designed to break-up and remove clots from the peripheral vascular system while reducing the risk of dislodged clots. Contraindications The JETi AIO Peripheral Thrombectomy System is contraindicated for use in: Patients treated with JETi in a single-session required less TPA and shorter ICU stays compared to those treated with overnight CDT. Inagaki E, Farber A, Kalish JA, et al. The JETi8 system may be a safe and effective option for thrombectomy of acute DVT. The power socket-outlet must be located near the device and must be easily accessible. Jeti thrombectomy system. Additional Endpoints Walk Vascular's JETi Peripheral Thrombectomy System and next-generation JETi AIO (All In One) Peripheral Thrombectomy System are unique aspiration systems for the removal of intravascular clots . The JETi AIO Peripheral Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. The systems are backed by real-world clinical experiences, and Walk is currently enrolling up to 250 patients in the USA and Europe in the Jeti Registry. It was recently announced that Veryan Medical will support Walk Vascular in the commercialisation of the Jeti peripheral thrombectomy system in Germany. official website and that any information you provide is encrypted JETi is the best of both worlds - the simplicity of manual aspiration with the clot busting power of a high-pressure saline jet; The jet is positioned within the catheter mouth to ensure thrombus is first held securely, before it is engaged by the jet, resulting in minimal risk of hemolysis or embolic showering JETi Masters value its speed and versatility Prolonged ischemia in the periphery can threaten tissue viability, meaning fast Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. All data met the acceptance criteria and fell within pre-determined product The JETi AIO Peripheral Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. The study will register approximately 250 subjects at up to 30 centers in the US and EU. Patients were treated endovascularly or through a hybrid surgical approach. Indications, limb salvage, and major adverse events were reviewed. Eur J Vasc Endovasc Surg. The innovative JETi systems are designed to break-up and . Please Enter the Pop Up text to be displayed in Pop Up here. *Angioplasty, stenting, open thrombectomy. Restoration of inline flow was successfully achieved in 77% of patients in a single session. The JETi Peripheral Catheter, JETi AIO Suction Tubing, JETi AIO Non-Sterile Kit, and JETi Pump Set contents are for single patient use only. Read our collection of Pounce Thrombectomy System case reports to discover how this innovative device can help overcome some of the real-world challenges experienced by physicians. The JETi Registry is a prospective, multi-center, observational study to collect real-world data on the safety, performance, and clinical benefits of the JETi Peripheral Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. The JETi AIO Peripheral Thrombectomy System is not approved for use with defibrillation. Both the JETi Peripheral Thrombectomy Systems have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the aspiration and breaking up of soft emboli and thrombus . See how the new dual-action technology in the JETi Hydrodynamic Thrombectomy System aspirates and fragments clot within the catheter tip. The system's name comes from the company's radiation-enhanced thrombectomy intervention technology. Catheter-directed thrombectomy with the JETi8 in the treatment of acute superior vena cava syndrome. Lopez R, DeMartino R, Fleming M, Bjarnason H, Neisen M. J Vasc Surg Venous Lymphat Disord. [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, Single-session treatment of lower extremity venous thrombosis using a novel thrombectomy device, Single-session treatment of patients with symptomatic venous thrombosis, Single-center experience for acute and subacute lower extremity ischemia, Percutaneous thrombectomy for the treatment of venous thromboembolism, Coronary, pulmonary, and neurovasculature. Contamination of the device may lead to injury, illness, or death of the patient. For deep vein thrombosis cases, the PEARL Registry data demonstrated 34% of patients were treated in a single session 75% of procedures were completed in < 24 hours This study evaluated the safety and efficacy of the JETi8 peripheral thrombectomy system in treating acute deep vein thrombosis (DVT). Precautions When the catheter is exposed to the arterial system, it should be manipulated while under high-quality fluoroscopic observation. The power socket-outlet must be located near the device and must be easily accessible. Mike Matson, an analyst with Needham . Contraindications The JETi AIO Peripheral Thrombectomy System is contraindicated for use in: To study the efficacy of the JETi Peripheral Thrombectomy System in treating acute venous thrombosis. Only use the JETi Peripheral Catheter and JETi AIO Suction Tubing with the JETi AIO Peripheral SDU. Indicates a trademark of the Abbott group of companies. The company has begun a limited commercial release of the 8-F catheter in North America and Western Europe, with plans for additional . Do not reuse, reprocess, modify, or resterilize. Mean aspirated volume was 531 mL (range, 250-1,230 mL). Potential adverse events include, but are not limited to: JETi is a trademark of Walk Vascular. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . JETi Therapy Manager at Abbott Vascular 2mo Dr Michael Lichtenberg -- 2mo Mechanical thrombectomy has supersede thrombolysis in the venous and arterial field. Walk's offerings include the JETi Peripheral Thrombectomy System and a complete version of the system, which includes an internal vacuum pump to remove blood clots instead of a separate suction system. Walk Vascular is a subsidiary of the Abbott Group of Companies. AngioJet Peripheral Thrombectomy System Boston Scientific. Methods Brand Name: JETi Thrombectomy System, Sterile Disposable Components Kit, 8 Fr Version or Model: WV8803-1 Commercial Distribution Status: Not in Commercial Distribution Catalog Number: Company Name: WALK VASCULAR L.L.C. Acute lower extremity ischemia (ALEI) is a vascular emergency with a mortality rate of 15-20%2. In this. #proudtobeabbott #abbottcardio #thrombectomy #JETi. Read our privacy policy to learn more. Mean aspirated volume was 531 mL (range, 250-1,230 mL). Acute Limb Ischemia: An Update on Diagnosis and Management. Expand 82 PDF Save Alert *Data includes 7 patients requiring overnight CDT. Copyright 2019 SIR. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Walk Vascular's JETi Peripheral Thrombectomy System and next-generation JETi AIO Peripheral Thrombectomy System are aspiration systems for the removal of intravascular clots. Recurrent thrombosis was observed in 5 patients (24%), of whom 3 were successfully treated with the JETi8 system. In the event shock must be delivered to the patient, remove the catheter and clear all connected system components from the patient before delivering shock. The https:// ensures that you are connecting to the Both JETi systems have garnered FDA 510(k) clearance and CE mark and the company is currently enrolling up to 250 patients in the U.S. and Europe in the JETi Registry. Mechanical thrombectomy has supersede thrombolysis in the venous and arterial field. 7905 Golden Triangle DriveSuite 190Eden Prairie, MN 55344USAToll Free: 888-626-8501Phone: 952-500-7400Fax: 952-500-7001, IDA Business ParkBallinasloe, Co. GalwayIrelandPhone +353 90 9646300Fax +353 90 9646309. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. This site needs JavaScript to work properly. Allowing JETi Masters best potential for: The JETi Registry is a prospective, multi-center, observational study to collect real-world data on the safety, performance, and clinical benefits of the JETi Peripheral Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. The JETi AIO Peripheral Thrombectomy System is contraindicated for use in: The JETi Peripheral Catheter, JETi AIO Suction Tubing, and JETi Pump Set contents are supplied sterile using EO. product JETi Thrombectomy System Mechanical Thrombectomy Catheter Manufacturer Info Walk Vascular, LLC 17171 Daimler St 92614 Irvine, CA USA dave JETi.tv Home to the JETi Thrombectomy System LinkedIn Twitter Instagram Facebook Why to use it Because it WORKS! To avoid risk of electric shock, the SDU must only be connected to mains power with a protective earth. The JETi systems helps to break-up and remove clots from the peripheral vascular system while minimising the risk of dislodged clots, said the company. Background Do not step or stand on the base of the device. The JETi AIO Peripheral Thrombectomy System is intended to: - remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and - subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. Vascular Study Group of New England. Its a grab and go percutaneous mechanical thrombectomy solution that empowers physicians to strike quickly, capturing and removing clot simply from the peripheral arterial vasculature The innovative JETi systems are designed to break-up . Do not step or stand on the base of the device. This site uses cookies. Detailed Description: Statement of Equivalence: The device is connected to a suction generator which can be either a Penumbra pump or a . Published by Elsevier Inc. All rights reserved. eCollection 2022 Sep. Percutaneous manual aspiration thrombectomy followed by stenting for iliac vein compression syndrome with secondary acute isolated iliofemoral deep vein thrombosis: a prospective study of single-session endovascular protocol. Walk Vascular - Home of the JETi Peripheral Thrombectomy System View more company details, employee count and revenue data on Kona Equity. Do not use if the expiration date has passed or the sterile barrier is damaged. JETi@ Thrombectomy System Description Sterile Disposables JETi 8Fr Procedure Kit (.035-.038) JETi 8Fr Sterile Kit (.035-.038) The JETi AIO Peripheral Thrombectomy System is contraindicated for use in: The JETi Peripheral Catheter, JETi AIO Suction Tubing, and JETi Pump Set contents are supplied sterile using EO. Physicians must read and understand the Instructions for Use (IFU) prior to using the device. In this. Olinic et al. Do not use a pump set if it does not prime. Technical success was achieved in93% of patients treatedwith the JETi Thrombectomy System. Procedural success rate was 100% (20 of 20 procedures). Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. The systems are backed by real-world clinical experiences, and Walk is currently enrolling up to 250 patients in the United States and Europe in the JETi Registry. The 6-to 8-Fr JETi device (Walk Vascular, Irvine, CA) is an aspiration catheter system that employs a focused high-pulse saline jet along the inner catheter lumen tip that fragments and lubricates clot during aspiration ( Fig. Prolonged ischemia in the periphery can threaten tissue viability, meaning fast and effective treatment is key to preserving both life and limb. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Learn more about the performance of the Pounce Thrombectomy System from those who have used it! The next Pounce & Pinot will be scheduled soon. Despite a challenging patient population, target thrombus was successfully removed in 85% of JETi cases with zero patient deaths at 30 days. Walk Vascular's JETi Peripheral Thrombectomy System and next-generation JETi AIO (All In One) Peripheral Thrombectomy System are unique aspiration systems for the removal of intravascular clots, known as thrombus, that can reduce blood flow and lead to serious complications for patients. The device must be used by physicians skilled in percutaneous, intravascular techniques in a fully equipped catheterization laboratory. In the event shock must be delivered to the patient, remove the catheter and clear all connected system components from the patient before delivering shock. Do not use if the expiration date has passed or the sterile barrier is damaged. 2022 Aug 5;8(3):545-548. doi: 10.1016/j.jvscit.2022.07.009. 2017;906:195-213. doi: 10.1007/5584_2016_116. Baril et al. Indicated to aspirate fluids from the body and the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature. Single-session restoration of flow was associated with shorter ICU stays and a60% lower dose of TPA when compared with overnight CDT. 2022 Surmodics, Inc. All Rights Reserved. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Walk Vascular's Jeti thrombectomy system employs an internal jet, located safely just inside its catheter mouth, capable of engaging large thrombus volumes through a miniature lumen, rapidly clearing peripheral . Technical success using the JETi8 system alone was 76% (16 of 21 procedures), whereas 5 procedures (24%) required subsequent overnight CDT in the intensive care unit. Peripheral Thrombectomy System. In the event that the catheter becomes blocked or clogged with thrombus, remove and replace the device with a new device. Treatment of acute iliofemoral deep vein thrombosis. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Are you a healthcare professional? No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Acquisition builds upon Abbott's leading vascular portfolio, adding mechanical thrombectomy devices for treating patients with peripheral blood clots Abbott (NYSE: ABT) announced today that it has acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots. Registration Number: 05797879. Indicates a third party trademark, which is property of its respective owner. Reuse, reprocessing, modification, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, may result in patient injury, illness or death. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Please be sure to read it. Unable to load your collection due to an error, Unable to load your delegates due to an error. Percutaneous mechanical thrombectomy is effective in the treatment of acute DVT in the upper and lower extremity to restore venous patency and valvular function and will be necessary to determine whether valVular function is maintained long-term. Do not use a catheter that has been kinked or damaged. 89% of patients met criteria for Rutherford IIa or IIb classification. [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, Single-center experience for acute and subacute lower extremity ischemia, Single-session treatment of patients with symptomatic venous thrombosis, Single-session treatment of lower extremity venous thrombosis using a novel thrombectomy device, Percutaneous thrombectomy for the treatment of venous thromboembolism.