Medical field. PH +33 (1) 39 21 77 46 Products. 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. The HydroCoil Embolic System (HES) provides superior occlusion efficacy and coil mass stability. The HydroCoil Embolic System treated aneurysms significantly decreases re-treatment rates and enhance long-term durability. According to the company, the detachable . This study will compare the study device to the standard bare platinum coil to see which is better at preventing future rupturing or leaking. The HydroCoil embolic system is a unique non-bioactive endovascular embolization device combining the company's platinum microcoil technology with a proprietary hydrogel. AJNR Am J Neuroradiol. Our Customer Name & Address . /PRNewswire/ -- MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, today announced that enrollment has begun in the Hydrogel Endovascular. BACKGROUND AND PURPOSE: The HydroCoil Embolic System (HES) was developed reduce recurrences of aneurysms relative to platinum coils. 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 . The Intelligel polymer is a responsive or "smart biomaterial" that does not swell until a period of contact with blood. This study was conducted to evaluate the recurrence rate of cerebral aneurysms 3-6 months after treatment with HES. 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. Device HydroFrame Model Number HydroFrame 18_9 The medical device MICROPLEX COIL SYSTEM (MCS) is realized by MICROVENTION INC. Trade name. AJNR Am J Neuroradiol. 19 Calculated in a similar way, our recurrence rate was 5.4% (8 of 148 patients). Table. 6. Cardiology. The HydroCoil Embolic System (HES) was developed to improve the packing efficacy of endovascular treatment of cerebral aneurysms. 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 study device is called the HydroCoil Embolization System and this study is a post-market clinical trial. 1 ). MHRA reference: 2022/001/020/601/003. 29 No. Yes, I am interested! Animal studies were conducted to evaluate the histological response elicited by the hydrogel coated coils. 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. 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). METHODS: We report the results in 135 cerebral aneurysms treated with HES in a prospective multicenter registry. 100203HS-V. 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. 20 January 2021. To further enhance ease of HES deployment, a new next generation embolic coil, the HydroFill coil, was developed. 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. 2004;25(1):60-62. Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. 2-5 These hydrogel coils occlude vessels mechanically as their gel coating expands in the bloodstream, thus decreasing reliance on clot formation. The purpose of this study is to study the 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. 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. : 0800 0220396 Fax: 0800 0220414 Laboratoires Terumo France . MicroPlex Coil System (MCS) (Embolization Coil) 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 . Coil embolization is an effective treatment for selected intracranial aneurysms. 1808. 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. Killer M, Arthur AS, Barr JD, Richling B, Cruise GM. But the HydroCoil Embolic System was characterized with many limitations. 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. This study was conducted to evaluate the recurrence rate of cerebral aneurysms 3-6 months after treatment with HES. 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. 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 . . We report our initial experience with the HES in the treatment of 11 . HydroCoil Embolic System (HES) and MicroPlex Coil System (MCS) Endovascular Embolization Coil . 1 In 2002, vascular coils coated with expandable hydrogel were introduced to embolize cerebral aneurysms. HydroCoil for Endovascular Aneurysm Occlusion (HEAL) Study: Periprocedural Results H.J. The HES may reduce recurrences of aneurysms by allowing for increased packing density as compared with platinum coils. Embolisation coils. 3. Clinical evidence. 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 . 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. A cerebral aneurysm is an abnormal, weakened . 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 HES may reduce recurrences of aneurysms by allowing for increased packing density as compared with platinum coils. 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 Coil swelling in vivo should theoretically result in greater aneurysm filling compared with inert . 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. 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: Angiographic results 3-6 . 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: MicroVention Terumo: HydroCoil Embolic System - HYDROSOFT 3D. A Prospective Multi-Center Study of the Effectiveness of the Hydrocoil Embolic System to Treat Intracranial Aneurysms. (HydroCoil Embolic System [MicroVention Inc., Tustin, Calif.]) have recently . Detailed Description: Alveoli on a Chip to Reveal Airflow Characteristics in Disease and Drug Delivery. HYDROGEL COILS HydroCoil Embolic System. Didn't find your product? 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 . Terumo Interventional Systems has announced the full commercial availability in the United States of the Azur Peripheral HydroCoil 35 platinum coil embolization system. 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. 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. The facility follows the Highest Quality Standards and is An ISO 9001:2008, ISO 14001:2004, ISO 13485:2003, WHO GMP & GPP Certified Company. MICROVENTION INC. Category Name. The manufacturing facility is situated in Roorkee, Uttarakhand. AZUR Peripheral Hydrocoil has superior mechanical stability 2-5 and offers the potential to use less coils which may provide cost saving per procedure. The Azur is a detachable hydrogel polymer embolic device with .035-inch coils and is compatible with .038-inch lumen catheters. About 600 subjects from multiple institutions will take part in this study. 07 . 2004;25(1):60-62. Consult our products in our . 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. HydroCoil for Endovascular Aneurysm Occlusion (HEAL) Study: Periprocedural Results H.J. Magnetic Steering System for Guidewires. Cloft HJ, Kallmes DF. 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. : +32 16 39 25 80 Fax: +32 16 39 25 99 The Netherlands: Tel. 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 . The HES may reduce recurrences of aneurysms . BACKGROUND . 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. 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. This coil is intended to give greater stability in challenging situations such as wide neck aneurysms or high-flow territories. Coils. Hydrocoil Embolic System (HES) consists of an implantable Hydrogel filled detachable coil attached to V Track delivery pusher. 6 www.pjms.com.pk 1335 intracranial aneurysms include absolute and relative ones, referring to the neck width 4mm and Embolization coils covered by the MRI Safety Information. 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 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 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. 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. Device HydroFrame Model Number HydroFrame 18_8 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. 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. Boulos AS, Shownkeen H, Thornton J. Deshaies EM, Brennan P, Fanning N 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 is a unique non-bioactive endovascular embolization device combining MicroVention's platinum microcoil technology with a proprietary hydrogel. 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 . The HydroCoil Embolic System (HES) was developed to reduce recurrences of aneurysms relative to platinum coils. GREAT was a prospective randomized controlled trial that enrolled 513 patients at 22 hospitals in France and Germany. Aneurysm packing with HydroCoil Embolic System versus platinum coils: initial clinical experience. 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