19 Calculated in a similar way, our recurrence rate was 5.4% (8 of 148 patients). Coil embolization is an effective treatment for selected intracranial aneurysms. The HydroCoil Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. HydroCoilEmbolic System Key Benefits: Three softness grades for framing, filling and finishing Concentric filling with soft and extra soft implants HydroFrame18 6-20 / 19-48 HydroFrame10 4-10 / 5-36 HydroSoft3D 1-3 / 2-10 HydroSoftHelical 1.5-6 / 2-20 Platinum Coils We report our initial experience with the HES in the treatment of 11 . Histomorphology of thrombus organization, neointima formation, and foreign body response in retrieved human Summary: The HydroCoil Embolic System (HES; MicroVention, Aliso Viejo, CA) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. Dear customer, MicroVention is initiating a voluntary field safety corrective action (FSCA) for the HydroCoilEmbolic System (HES) and MicroPlex Coil System (MCS) Endovascular Embolization products. The hydrogel polymer is a biomaterial that does not swell until a period of contact with blood. 6. The HydroCoil embolic system is a unique non-bioactive endovascular embolization device combining the company's platinum microcoil technology with a proprietary hydrogel. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm. The HydroCoil Embolic System (HES; MicroVention, Aliso Viejo, CA, USA) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. About 600 subjects from multiple institutions will take part in this study. 2004; 25(1): 60-62. Hydrocoil; Has Expanded Access: No Condition Browse: Intracranial Aneurysm; Aneurysm; Number Of Arms: 2 Arm Group: Label: HydroCoil Embolic System Type: Other Description: Aneurysm treatment using the HydroCoil Embolization System (21 CFR 882.5950) Label: Control Type: Other Description: Aneurysm treatment using bare platinum coil(s) Acronym: HEAT The HydroCoil Embolic System is a unique non-bioactive endovascular embolization device combining MicroVention's platinum microcoil technology with a proprietary hydrogel. Initial animal studies of HC revealed an increased cellular response, thicker neointima, and better sealing at the neck of the aneurysm compared to bare platinum coils . A basic section introduces the major topics while a library full of hundreds of devices is available to search, filter, and explore to learn about the specifications that differentiate them. EMBOLIZATION IMPLANTS AND SYSTEMS. The hydrogel polymer is a biomaterial that begins to swell after a brief period of contact with blood, giving physicians the ability to precisely control delivery of the . Objective: To explore the treatment effects of HydroCoil Embolic System (HES) on large- and medium-sized intracranial aneurysms. 1 ). BACKGROUND AND PURPOSE: The HydroCoil Embolic System (HES) was developed reduce recurrences of aneurysms relative to platinum coils. DURABLE Multi-center HES Registry (Albany Medical . HydroCoil for Endovascular Aneurysm Occlusion (HEAL) Study: Periprocedural Results H.J. HydroCoil Embolic System Pak J Med Sci 2013 Vol. MicroVention Terumo: HydroCoil Embolic System - HYDROSOFT 3D. The older approach uses bare platinum coils (BPCs), and new devices use the HydroCoil Embolic System (HES), which uses platinum coils containing a hydrogel polymer that, once in contact with blood, expands to fill the coil lumen. 2004;25(1):60-62. DURABLE Multi-center HES Registry (Albany Medical Center, Beaumont Regional Medical Center, Loyola University Medical Center) of 260 aneurysms with 186 follow-ups treated with HydroCoil. We retrospec. 5 SUPERIOR FILLING VOLUME AND PACKING DENSITY COMPARED TO BARE PLATINUM COILS 4 The AZUR Peripheral HydroCoil Embolization System combines a platinum coil and an expandable hydrogel polymer. 07 . Coil System and the HydroCoil Embolic System, its next-generation endovascular coil system. HydroCoil features a nonbioactive, inert hydrogel core that absorbs water from the blood and surrounding tissue to create a stable, mechanical platform for natural tissue proliferation and long-term aneurysm occlusion. The Intelligel polymer is a responsive or "smart biomaterial" that does not swell until a period of contact with blood. The HydroCoil Embolic System (HES; MicroVention, Aliso Viejo, CA) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. The HydroCoil Embolic System (HES) was developed to reduce recurrences of aneurysms relative to platinum coils. The manufacturing facility is situated in Roorkee, Uttarakhand. . The purpose of this study is to collect information (data) on the use of a particular type of hydrogel coils known as the HydroCoil Embolic System (HES). According to the company, the detachable . MicroPlex Coil System (MCS) (Embolization Coil) The HydroCoil Embolic System (HES; MicroVention, Aliso Viejo, CA) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. Cloft, for the HEAL Investigators BACKGROUND AND PURPOSE: The HydroCoil Embolic System (HES) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V; 100204H2HS-V; 100206H2HS-V, 100208H2HS-V, 100254H2HS-V, 100256H2HS . HYDROGEL COILS HydroCoil Embolic System. : +32 16 39 25 80 Fax: +32 16 39 25 99 The Netherlands: Tel. Boulos AS, Shownkeen H, Thornton J. Deshaies EM, Brennan P, Fanning N Since the launch of their First Generation HydroCoil embolic system in 2003, MicroVention has expanded its portfolio to every corner of the neuroendovascular industrynow producing Best-in . MHRA reference: 2022/001/020/601/003. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial. Manufacturer of the medical device. PH +33 (1) 39 21 77 46 HydroCoil 45-450405 AZUR 35D System 4 mm x 5 cm 4 5 3.98 0.048 4.85 58.37 45-450410 AZUR 35D System 4 mm x 10 cm 4 10 7.96 0.048 9.71 116.75 45-450415 AZUR 35D System 4 mm x 15 cm 4 15 11.94 0.048 14.56 175.12 45-450610 AZUR 35D System 6 mm x 10 cm 6 10 5.31 0.048 6.47 116.75 45-450615 AZUR 35D System 6 mm x 15 cm 6 15 7.96 0.048 9.71 175.12 Description. This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS Evo and HydroCoil Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure Detailed Description: Coils. The purpose of this study is to study the The coil is detached using a V Grip Detachment System. 20 January 2021. Objective To report the rst clinical experience with the HydroFill coil, focusing on . Coil swelling in vivo should theoretically result in greater aneurysm filling compared with inert . Clinical evidence. AZUR Peripheral Hydrocoil has superior mechanical stability 2-5 and offers the potential to use less coils which may provide cost saving per procedure. Device HydroFrame Model Number HydroFrame 18_9 This study was conducted to evaluate the recurrence rate of cerebral aneurysms 3-6 months after treatment with HES. This coil is intended to give greater stability in challenging situations such as wide neck aneurysms or high-flow territories. Others, such as the Interlock-35 System and its derivatives (Boston Scientific), feature a mechanical connection between the coil and delivery wire that disengages when the detachment zone at the base of the coil passes beyond the tip of the delivery catheter. Our The HydroCoil Embolization System is a unique non-bioactive endovascular embolization device combining the Company's platinum microcoil technology with a proprietary, highly-expandable microporous hydrogel. Detailed Description: AJNR Am J Neuroradial. The HydroCoil Embolic System (HES; MicroVention, Aliso Viejo, CA) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. AZUR Peripheral HydroCoil Embolization System Superior Filling Volume and Packing Density AZUR Peripheral Hydrocoil Embolization System - The Technology of Expansion The AZUR Peripheral HydroCoil Embolization System combines a platinum coil and an expandable hydrogel polymer. This study will compare the study device to the standard bare platinum coil to see which is better at preventing future rupturing or leaking. Summary: The HydroCoil Embolic System (HES) comprises a platinum microcoil coated with an expansile polymer and is approved by the United States Food and Drug Administration for cerebral aneurysm occlusion. Alveoli on a Chip to Reveal Airflow Characteristics in Disease and Drug Delivery. Faith Innovations is a Manufacturing Company, focused on manufacturing world class products, adapted to Indian conditions. Cloft, for the HEAL Investigators BACKGROUND AND PURPOSE: The HydroCoil Embolic System (HES) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. The HydroCoil Embolic System (HES) provides superior occlusion efficacy and coil mass stability. 2-5 These hydrogel coils occlude vessels mechanically as their gel coating expands in the bloodstream, thus decreasing reliance on clot formation. HYDROCOIL EMBOLIC SYSTEM (HES) Product Code: 100204HES-V: Manufacturer of the medical device: MICROVENTION INC. Category Name: EMBOLIZATION IMPLANTS AND SYSTEMS: Category Code: C0104020203: Sign repertoire: Registered: Group of similar Medical devices: 17411: Medical device reference: 0: Type: DeviceAID covers many types of devices used in coronary diagnostic and interventional procedures. /PRNewswire/ -- MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, today announced that enrollment has begun in the Hydrogel Endovascular. In non-clinical testing, the image artifact caused by the MicroPlex Coil System (MCS), Cosmos 18 extends approximately 5-mm from this device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system. Animal studies were conducted to evaluate the histological response elicited by the hydrogel coated coils. The facility follows the Highest Quality Standards and is An ISO 9001:2008, ISO 14001:2004, ISO 13485:2003, WHO GMP & GPP Certified Company. The HydroCoil Embolic System (MicroVention) is a recently developed coil technology designed to improve packing density. Consult our products in our . Interventional Oncology (4) AZUR CX Peripheral Coil System AZUR Framing Coil Peripheral Coil System AZUR Peripheral Hydrocoil - Detachable Peripheral Coil System AZUR Peripheral Hydrocoil - Pushable Peripheral Coil System. The HES may reduce recurrences of aneurysms by allowing for increased packing density compared with platinum coils. HydroCoil Embolic System, helical shape, for filling and finishing V-Grip detachment controller, self-contained integrated power supply, rapid coil detachment: 0.75 seconds The HES may reduce recurrences of aneurysms by allowing for increased packing density as compared with platinum coils. Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The study device is called the HydroCoil Embolization System and this study is a post-market clinical trial. The Azur is a detachable hydrogel polymer embolic device with .035-inch coils and is compatible with .038-inch lumen catheters. 1808. MICROVENTION INC. Category Name. Methodology: Fifty cases of intracranial aneurysm patients were retrospectively analyzed, in which 27 and 23 cases were treated with HES (n=27) and ordinary coils (n=23), respectively. 2004;25(1):60-62. Cloft HJ, Kallmes DF. The HydroCoil Embolic System (HES; MicroVention, Aliso Viejo, CA) was developed to improve the efficacy of endovascular treatment of cerebral aneurysms. HydroCoils are platinum helical coils coated with a layer of hydrophilic acrylic polymer (hydrogel), which on contact with blood causes disentanglement of polymer chains and expansion. The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) published in The Lancet, showed that the HydroCoil Embolic System for treating cerebral aneurysms reduced recurrence and retreatment rates and provided improved outcomes in study patients when compared to bare platinum coils. Delivery System Compatible with 0.0165" inner diameter microcatheters HydroFrame Coils HydroCoil Embolic System MicroVention Worldwide Innovation Center PH +1.714.247.8000 35 Enterprise Aliso Viejo, CA 92656 USA MicroVention UK Limited PH +44 (0) 191 258 6777 MicroVention Europe, S.A.R.L. 1 ). In that study, 11 patients (4.4%) met this definition of the 251 patients in the HydroCoil embolic system arm with primary end point data. Hydrocoil Embolic System (HES) consists of an implantable Hydrogel filled detachable coil attached to V Track delivery pusher. HydroCoil Embolic System (HES) and MicroPlex Coil System (MCS) Endovascular Embolization Coil . Customer Name & Address . Percutaneous coil embolization of vascular lesions became possible after the Gianturco steel coil was introduced in 1975. The HydroCoil Embolic System (MicroVention, Aliso Viejo, Calif) was designed to improve volumetric filling with an expansile hydrogel that should fill more of the aneurysm lumen than standard platinum coilsthus aiming to improve aneurysm stability and durabilityand it might provide a better scaffold to initiate neointima formation and . hydroframe@advanced embolic coils hydrocoil@ embolic system highly versatile optimized for framing, concentric filling and finishing engineered for enhanced softness and conformability in complex morphologies i soft complex shape with variable diameter loops utilizes the v-trak@advanced delivery system for excellent softness and contro/2 The HES may reduce recurrences of aneurysms . METHODS: We report the results in 135 cerebral aneurysms treated with HES in a prospective multicenter registry. The HydroCoil Embolic System (HES) was developed to improve the packing efficacy of endovascular treatment of cerebral aneurysms. The HES may reduce recurrences of aneurysms by allowing for increased packing density as compared with platinum coils. Although hydrocoils compared to . The HydroCoil Embolization System (HES) was developed to increase volumetric lling within the aneurysm sac to maintain long term occlusion. But the HydroCoil Embolic System was characterized with many limitations. The 513-patient prospective, randomized, controlled trial aimed to explore the use of the HydroCoil embolic system for treating endovascular aneurysms compared to bare platinum coils, the company . The manufacturer had recognized the challenge and recently a new design of hydrogel-coated coil-HydroSoft has become available in the market as the new . BACKGROUND . HydroCoil for Endovascular Aneurysm Occlusion (HEAL) Study: Periprocedural Results H.J. MICROPLEX COIL SYSTEM (MCS) Product Code. HYDROGEL COILS HydroCoil Embolic System. The medical device MICROPLEX COIL SYSTEM (MCS) is realized by MICROVENTION INC. Trade name. Didn't find your product? Headquartered in Tustin, California . 3. Table. All the patients were followed up for two years. 1 In 2002, vascular coils coated with expandable hydrogel were introduced to embolize cerebral aneurysms. The HES may reduce recurrences of aneurysms by allowing for increased packing density as compared with platinum coils. Cardiology. The HES may reduce recurrences of aneurysms by allowing for increased packing density as compared with platinum coils. : 0800 0220396 Fax: 0800 0220414 Laboratoires Terumo France . Embolisation coils. Sleep Monitoring at Home: Interview with Ziv Peremen, CEO of . Products. The HES is available in 18, 14 & 10 compatible systems that are compatible with various microcatheters. The first-generation HydroCoil embolic system (MicroVention, Tustin, CA, USA) is composed of a platinum core surrounded by a sleeve of expandable hydrogel and an outer wire with gaps that allows expansion to occur (Fig. In order to address these shortcomings, the HydroCoil Embolic System (HC) (MicroVention, Tustin, California, USA) was developed by adding a hydrogel coating to a platinum core. The HydroCoil Embolic system (MicroVention, CA, USA) was designed to improve volumetric filling with an expansile hydrogel that should fill more of the aneurysm lumen than standard platinum coils. Oscor Inc.: Destino Twist / Brand Name: Guidestar. If the denominator is adjusted for the smaller number of patients with an 18-month follow-up angiogram, this would be 8.2%. A cerebral aneurysm is an abnormal, weakened . Aneurysm packing with HydroCoil Embolic System versus platinum coils: initial clinical experience. 6 www.pjms.com.pk 1335 intracranial aneurysms include absolute and relative ones, referring to the neck width 4mm and The purpose of this study is to study the 100203HS-V. (HydroCoil Embolic System [MicroVention Inc., Tustin, Calif.]) have recently . Recently launched in early 2004 were the MicroPlex XT, a unique stretch-resistant and conformal platinum coil, and the HydroCoil 10 Embolic System, a stretch-resistant and highly flexible coil for small aneurysms. The HydroCoil Embolic System (HES; MicroVention, Aliso Viejo, CA) was designed as a platinum coil coated with a polymeric hydrogel that expands when it contacts aqueous pH balance solution such as blood, to increase filling volumes, improve mesh stability and elicit a healing response within the aneurysm . Yes, I am interested! Aneurysm packing with HydroCoil Embolic System versus platinum coils: initial clinical experience. Killer M, Arthur AS, Barr JD, Richling B, Cruise GM. Angiographic results 3-6 . In this study, we evaluate the packing efficacy of HES using a silicone model of ruptured cerebral aneurysm. Clear Choice HydroCoil by Microvention to fill Aneurysms very effectively and efficiently. AJNR Am J Neuroradiol. Terumo Interventional Systems has announced the full commercial availability in the United States of the Azur Peripheral HydroCoil 35 platinum coil embolization system. This study was conducted to evaluate the recurrence rate of cerebral aneurysms 3-6 months after treatment with HES. A registry is a place where medical information and other related information from patients is collected and stored for medical research. The HydroCoil Embolic System treated aneurysms significantly decreases re-treatment rates and enhance long-term durability. GREAT was a prospective randomized controlled trial that enrolled 513 patients at 22 hospitals in France and Germany. The hydrogel polymer is a biomaterial that begins to swell after a brief period of contact with blood, giving physicians the ability to precisely control delivery of the device. AZUR Framing coil is a platinum coil that offers a three-dimensional shape to cover the wall of an aneurysm or the inner lumen of an artery. To further enhance ease of HES deployment, a new next generation embolic coil, the HydroFill coil, was developed. 5,6 Hydrogel-coated coils (HydroCoils) consist of platinum coils covered with a hydrophilic polymer that swells in blood. Magnetic Steering System for Guidewires. A Prospective Multi-Center Study of the Effectiveness of the Hydrocoil Embolic System to Treat Intracranial Aneurysms. To improve coil packing density, hydrogel covered platinum coils were introduced relative to platinum coils (HydroCoil Embolic system; Fig. Aneurysm packing with HydroCoil Embolic System versus platinum coils: Initial clinical experience. Embolization coils covered by the MRI Safety Information. Medical field. The HydroCoil Embolic System is a unique endovascular embolization device combining the Company's platinum microcoil technology with a proprietary, highly-expandable microporous hydrogel called Intelligel. BACKGROUND AND PURPOSE:The HydroCoil Embolic System (HES) was developed reduce recurrences of aneurysms relative to platinum coils. AJNR Am J Neuroradiol. Detachable 18 System/Pack of 1 coil Peripheral HydroCoil Embolization System IS157GB0109MDVI(1212)E www.terumo-europe.com European Offices Terumo Europe N.V. Benelux Sales Division Interleuvenlaan 40 3001 Leuven, Belgium Tel. Device HydroFrame Model Number HydroFrame 18_8 There are 3 basic configurations. (in-vivo study) 7. 29 No. Terumo Corp. (TYO: 4543) subsidiary MicroVention today released results from a study of its HydroCoil embolic system, touting that the trial met its primary and secondary endpoints and showed low . 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