Middle ear reconstruction using the titanium Kurz Variac partial ossicular replacement prosthesis: functional results Please note that the full functionality of the website may no longer be available depending on the settings you choose. When used with middle ear cements, such as glass ionomer cement, endoskeletal ossicular reconstruction is possible. Clip Partial Prosthesis Titanium (Dresden type) 0.2 x 3.5-mm Kurz Medical, www.kurzmed.com/en/products/mri-safety/ Open zones help facilitate vascular supply to the mucosa. AnnuloFlo Mitral Annuloplasty Device Size 36 Model AR-736 Titanium Sulzer Carbomedics, Inc., www.sorin.com Most of the prostheses were then placed in a water-filled Petri dish and reintroduced into the MRI unit. As pointed out in the prior section on history, patients requiring a total ossiculoplasty generally have advanced disease. Common materials used to make the prostheses are platinum, a combination of platinum and PTFE and, increasingly, titanium. The Eclipse Titanium Nitinol Piston is the first Nitinol piston featuring a titanium shaft. Due to the CliP Design. The titanium Kurz TTP-Variac System PORP is an effective prosthesis to reconstruct the ossicular chain. 2.12 Information Bearing on the Safety and Effectiveness: [807.92 (b)(3)] Like some lengths of the K-Piston Titanium Stapedial Prosthesis, the CliP® Piston MVP is used for bridging the stapes and incus in cases of otosclerosis in malleovesti-bulopexy procedures. All patients with a metallic stapes prosthesis may be sent to the MRI scanner, with the exception of 1 specific defective prosthesis type. The Nitinol clip is made of superelastic Nitinol. Magnetic Resonance Imaging (MRI) Safety Information for Zimmer Implants. MRI scanners and the stapes prosthesis. Contact details +49 7072 91 79 - 0; info@kurzmed.com; Heinz Kurz GmbH Medizintechnik Tuebinger … REF Number Brand Name Material 1007103- 1007111; 1007153- 1007161 NiTiBOND Stapes Prosthesis Pure Titanium / Nitinol Metal: Many knee implants include metal and plastic. AccessGUDID - MNP Total Prosthesis Titanium (EHKM10044431)- Ossicular Prosthesis, total Common materials used to make the prostheses are platinum, a combination of platinum and PTFE and, increasingly, titanium. While MRI related artifacts are not a primary safety issue for implants, the presence of an artifact may affect the diagnostic imaging quality of an MRI examination if the area of interest is in the exact same position where the heart valve prosthesis is located. Authors Souheil M ... Methods: Each metallic prosthesis was placed in an empty Petri dish and introduced into a 1.5-tesla (T) magnetic resonance imaging (MRI) unit. Long-term hearing result using Kurz titanium ossicular implants Hess-Erga J., Møller P., Vassbotn F. S. In 2008, we began using a special combination of super-elastic nitinol with PTFE. Paul, M. Clip 250, double tantalum clip (tantalum)ocularMira Inc. Eclipse Titanium Nitinol Piston . Products for Rhinology, Laryngology and Ophthalmology complete our ENT program. The ENT assortment is rounded off by products for Rhinology, Laryngology and Ophtalmology. The titanium Kurz TTP-Variac System PORP is an effective prosthesis to reconstruct the ossicular chain. Well established anatomical understanding and latest results of scientific research as well as extensive test series are the basis for these developments. When applying heat to the ContactFree Zones, the shape memory features of Nitinol cause the loop to close. Retrospective chart reviews were performed fo … Short-term Results Using Kurz Titanium Ossicular Implants Eur Arch Otorhinolaryngol. already available with the predicate device CliP® Conclusion: All patients with a metallic stapes prosthesis may be sent to the MRI scanner, with the exception of 1 specific defective prosthesis type. Section 1.1 MRI Safety Information NiTiBOND Non-clinical testing has demonstrated the products listed below are MR Conditional. They can be scanned safely under the following conditions listed beneath the table. Clip 50, double tantalum clip (tantalum)ocularMira Inc. The manufacturing process of our prostheses requires highest precision and quality standards as well as utmost care. KURZ delivers a broad variety of Passive Middle Ear Implants, Ventilation Tubes and Precision Instruments. Safety of MRI with metallic middle ear implants J Med Liban. AccessGUDID - MNP Total Prosthesis Titanium (EHKM10044381)- Ossicular Prosthesis, total All titanium implants are MRI compatible. MR Conditional means that non-clinical testing has demonstrated that the implant can be scanned safely under specific conditions. TABLE 2: Stryker/Leibinger FISCH Titanium Incus Prosthesis Comparison to Karl Storz FISCH Titanium Incus Prosthesis DEVICE STRYKER/ LEIBINGER -FISCH KARL STORZ -FISCH TITANIUM TITANIUM INCUS PROSTHESIS INCUS PROSTHESIS (K993583) 1. This is a webpage for medical professionals. Offset ALTO Total Prosthesis MRI information applies to Buckets Titanium, CP2 & CP4 P/N 420-XXX through 430-XXX OCRs, Middle Ear Implants Titanium CP2, other materials HA and silicone ALTO 600 Series Titanium . Heinz Kurz GmbH MedizintechnikTuebinger Straße 372144 DusslingenGermany, We use cookies (including third party cookies) to offer you the best possible online experience and to be able to further enhance our website. The Coloplast® Titan® inflatable penile prosthesis is a self-contained, fluid-filled system made from Bioflex and silicone. This is particularly important during cases where more extensive eardrum reconstruction is required. The superiority of these new implants compared to previous middle ear prostheses with respect to biocompatibility, hearing improvement and intraoperative manipulation became evident even in the testing phase. The superiority of these new implants compared to previous middle ear prostheses with respect to biocompatibility, hearing improvement and intraoperative manipulation became evident even in the testing phase. A solid, implantable device used for vocal cord medialization thyroplasty (removal of a "window" of cartilage from the outside of the voice box and replacing it with a prosthesis to push a paralyzed vocal cord toward the middle of the voice box) to treat patients with unilateral vocal cord paralysis to improve voice quality. Meulemans J., Wuyts F. L., Forton G. E. J. Study Design: Survey and animal model. INTENDED USE Incus replacement to connect malleus Same and head of stapes. Objective: Assess the safety of performing magnetic resonance imaging (MRI) on patients with stapes prostheses. The objective of the study was to determine whether a titanium piston stapes prosthesis would be audiometrically and surgically equivalent to a Robinson stainless steel piston for stapedectomy. The titanium piston body provides superior imaging qualities compared to fluoroplastic. USED MOST OFTEN WORLDWIDE. 2.12 Information Bearing on the Safety and Effectiveness: [807.92 (b)(3)] Like some lengths of the K-Piston Titanium Stapedial Prosthesis, the CliP® Piston MVP is used for bridging the stapes and incus in cases of otosclerosis in malleovesti-bulopexy procedures. This is not by chance! It is often safe to perform MRI on an individual that has an orthopaedic implant device. Titanium is thought to provide excellent sound conduction even at higher frequencies because of its small mass. From a long-term perspective, the prostheses have proven … A revision stapedectomy with an MRI-safe implant is recommended in patients with the mis-manufactured 1987 stapes prosthesis who absolutely need an MRI. TYMPANOPLASTY; … Jul-Sep 2003;51(3):127-31. Clip 51, single tantalum clip (tantalum)ocularMira Inc. When used with middle ear cements, such as glass ionomer cement, endoskeletal ossicular reconstruction is possible. Magnetic Resonance Imaging (MRI) is a commonly accepted and widely used diagnostic medical procedure. Conclusion and Relevance: The titanium Kurz TTP-Variac System PORP is an effective prosthesis to reconstruct the ossicular chain. The prosthesis serves as “rebar” for the cement. The development of the KURZ® NiTiFLEX has been an important milestone in the evolution of stapes prostheses. The exception is a 1987 accidental mismanufacture of several lots of McGee pistons with a magnetic alloy. Innovative KURZ product designs and materials have set new standards in middle ear prosthetics throughout the world. This places high demands on the development of implants. Methods: A survey regarding implant usage, MRI procedures, and adverse outcomes after MRI in patients previously undergoing stapes procedures. KURZ is one of the world's leading manufacturers of passive middle ear implants, ventilation tubes and specialized precision instruments. adverse tissue effects attributable to MRI-generated heating. Home; Products. Objective: Assess the safety of performing magnetic resonance imaging (MRI) on patients with stapes prostheses. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. A small number of metallic tubes made of titanium, gold-platinum, or gilt silver exist; these are considered "MR Conditional." Clip BoardNewmatic Medical, www.newmaticmedical.com, Clip Partial Prosthesis Titanium(Dresden type)0.2 x 3.5-mmKurz Medical, www.kurzmed.com/en/products/mri-safety/, Clip Partial ProsthesisKurz Medical, www.kurzmed.com/en/products/mri-safety/, Clip Piston aWengen TitaniumKurz Medical, www.kurzmed.com/en/products/mri-safety/, Closed-back halo (titanium)halo and cervical fixationDePuy ACE Medical Co.El Segundo, CA, CLYDESDALE PEEK (polyetheretherketone)Vertebral Body SpacerMEDTRONICSpinal and BiologicsMemphis, TN - Please refer to the labeling documents available at www.medtronic.com/mri, CO-Set Room Temperature Injectate KitEdwards Lifesciences, www.edwards.com, Coaxial Needle Set Chiba-type22 G, 5-7/8 inch biopsy needle(304 SS)InradGrand Rapids, MI, Coaxial Needle Set Introducer19G, 2-15/16 inch biopsy needle(304 SS)InradGrand Rapids, MI. Objective: Assess the safety of performing magnetic resonance imaging (MRI) on patients with stapes prostheses. Long-term hearing result using Kurz titanium ossicular implants Hess-Erga J., Møller P., Vassbotn F. S. Prosthesis materials. Patients with these specifically identified lots of McG … MRI scanners and the stapes prosthesis Otol Neurotol. AnnuloFlo Mitral Annuloplasty Device Size 36 Model AR-736 Titanium Sulzer Carbomedics, Inc., www.sorin.com Complications are rare, illustrating the safety of the prosthesis. Study Design: Survey and animal model. 2. This includes cookies which are necessary for the operation of the website and cookies which are used solely for anonymous statistical purposes. Study design: Retrospective chart review. Study design: Survey and animal model. Pure titanium; Low mass and high rigidity; Rounded distal end of the prosthesis; Rounded between the piston segment and the loop area ; Fixed length availability; Distal end diameter 0.4 and 0.6 mm; Piston surgical technique; MR conditional for the future: 7.0 Tesla; Product Information. The Kraus K-Helix Prosthesis (endohelix prostheses) is a novel, titanium middle ear prostheses that has been designed specifically for reconstruction of the ossicular chain. Most of the prostheses were then placed in a water-filled Petri dish and reintroduced into the MRI unit. adverse tissue effects attributable to MRI-generated heating. The stapes prosthesis consists of a Nitinol loop and the standard KURZ shaft made of pure titanium (ASTM F67). In 2008, we began using a special combination of super-elastic nitinol with PTFE. 3 Cobalt chrome is the most common type of knee implant, though titanium is available for people with a nickel allergy. Mandatory field Please enter search term * Search Library Clinical Evidence Certificates. As MRI scanners become more powerful, the possibility for stapes prosthesis displacement due to ferromagnetic forces increases. INTENDED USE Incus replacement to connect malleus Same and head of stapes. ALTO Partial and Total Prosthesis Device Family, ALTO Partial and Total Prosthesis; Family Product Number(s), 6XX; Device Material(s), Titanium, HA (hydroxyapatite), Silicone The focus of our review is to demonstrate the value of the two-point stabilization in total ossiculoplasty. Thorough understanding of middle ear mechanics and clinical evidence makes KURZ® one of the most advanced Middle Ear reconstruction systems worldwide. We call this our most challenging quality control and use it as an incentive to prove to ourselves that we can live up to the standards of our best critics. The NiTiFLEX is a stapes prosthesis for partial replacement of the ossicular chain, It consists of a Nitinol clip and the standard KURZ shaft (piston) made of pure titanium with a diameter of 0.4 and 0.6 mm (ASTM F67). KURZ medical technology, an ENT company focused on Passive Middle Ear Implants and Prostheses in Titanium and Nitinol. Setting: Private otology practice. Information concerning the MRI-Safety is stored in PDF-format here >> KURZ once again pioneered this kind of safety feature and for over a decade it has remained the market leader. AccessGUDID - MNP Total Prosthesis Titanium (EHKM10044381)- Ossicular Prosthesis, total Conclusions and Relevance The titanium Kurz TTP-Variac System PORP is an effective prosthesis to reconstruct the ossicular chain. Prosthesis materials. Objective: Physicians and patients alike have concerns regarding exposing in vivo implanted metal stapes prostheses to magnetic resonance imaging (MRI) scanners. +49 7072 91 79 - 0; info@kurzmed.com; NEXT Skip navigation. 5 The most recent study in the literature, by Williams et al, 6 found that all prostheses made from nonferromagnetic metals (316L stainless steel [SS]), which had been found in prior studies to be safe at 1.5 T, did move in the presence of higher magnetic fields at 4.7 T. … 2013 Oct 139(10):1017-25. read more . It is often safe to perform MRI on an individual that has an orthopaedic implant device. The first KURZ® Titanium Prosthesis was designed in 1994 in conjunction with doctors of the Dominikus Hospital in Duesseldorf. Clip Partial Prosthesis Titanium (Dresden type) 0.2 x 3.5-mm Kurz Medical, www.kurzmed.com/en/products/mri-safety/ Hess-Erga J., Møller P., Vassbotn F. S. Published: European Archives of Oto-Rhino-Laryngology, May … Complications are rare, illustrating the safety of the prosthesis. The Kraus K-Helix Prosthesis (endohelix prostheses) is a novel, titanium middle ear prostheses that has been designed specifically for reconstruction of the ossicular chain. These specifically identified lots of McG … MRI scanners and the stapes head and thus enhances safety for good! Tubes and specialized precision Instruments is recommended in patients with stapes prostheses to magnetic resonance imaging ( )! 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