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. OTOLOGY. Titanium is thought to provide excellent sound conduction even at higher frequencies because of its small mass. 3 Cobalt chrome is the most common type of knee implant, though titanium is available for people with a nickel allergy. Find the responsible partner for your country or contact us directly. Details on the MR conditions for each Implant are given on the Metal: Many knee implants include metal and plastic. The titanium piston body provides superior imaging qualities compared to fluoroplastic. Prosthesis materials. Safety of MRI with metallic middle ear implants J Med Liban. Complications are rare, illustrating the safety of the prosthesis. Indications, Safety, and Warnings Indications. This way, we can offer ingenious solutions for a broad variety of reconstruction demands. Study Design: Survey and animal model. Clip Partial Prosthesis Titanium (Dresden type) 0.2 x 3.5-mm Kurz Medical, www.kurzmed.com/en/products/mri-safety/ Information concerning the MRI-Safety is stored in PDF-format here >> In ossicular chain reconstruction, maximal rehabilitation of conductive hearing loss is the ultimate goal. Objective: Physicians and patients alike have concerns regarding exposing in vivo implanted metal stapes prostheses to magnetic resonance imaging (MRI) scanners. This places high demands on the development of implants. AccessGUDID - MNP Total Prosthesis Titanium (EHKM10044381)- Ossicular Prosthesis, total Safety of MRI with metallic middle ear implants J Med Liban. 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. … In 2008, we began using a special combination of super-elastic nitinol with PTFE. Please find further information in our. Totally implantable active middle ear implants. The exception is a 1987 accidental mismanufacture of several lots of McGee pistons with a magnetic alloy. All titanium implants are MRI compatible. Information concerning the MRI-Safety is stored in PDF-format here >> This is a webpage for medical professionals. The flat loop band diffuses the impact of pressure on the incus. When applying heat to the ContactFree Zones, the shape memory features of Nitinol cause the loop to close. 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. Complications are rare, illustrating the safety of the prosthesis. Section 1.1 MRI Safety Information NiTiBOND Non-clinical testing has demonstrated the products listed below are MR Conditional. Please note that the full functionality of the website may no longer be available depending on the settings you choose. Included in this study was a Kurz partial titanium prosthesis, which was found to have a low but present magnetic dipole moment. Taking the proven benefits of their CliP technology KURZ® has made the CliP from superelastic nitinol that greatly reduces the attachment force on the incus. Especially in the case of extensive eardrum reconstructions this stability is a major advantage. Study design: Retrospective chart review. We are proud that leading national and international scientists, medical experts and engineers have scrutinized our products in independent studies for the past twenty years. 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. Common materials used to make the prostheses are platinum, a combination of platinum and PTFE and, increasingly, titanium. The focus of our review is to demonstrate the value of the two-point stabilization in total ossiculoplasty. There were few complications (1 prosthesis extrusion, 2 prosthesis dislocations, 2 reperforations, 3 cases of residual cholesteatoma, and 3 of light sensorineural hearing loss). The Nitinol clip is made of superelastic Nitinol. Artifacts were characterized for the 32 different heart valve prostheses using a previously published grading scheme. Middle Ear Reconstruction Using the Titanium Kurz Variac Partial Ossicular Replacement Prosthesis. 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). Patients with these specifically identified lots of McG … MRI scanners and the stapes prosthesis Otol Neurotol. CliP and Ball-joint designs VARIAC System & MR conditional PLEASE CONTACT US. Well established anatomical understanding and latest results of scientific research as well as extensive test series are the basis for these developments. Clip 50, double tantalum clip (tantalum)ocularMira Inc. Objective: Assess the safety of performing magnetic resonance imaging (MRI) on patients with stapes prostheses. 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. Study Design: Survey and animal model. INTENDED USE Incus replacement to connect malleus Same and head of stapes. Clip 51, single tantalum clip (tantalum)ocularMira Inc. Paul, M. Clip 250, double tantalum clip (tantalum)ocularMira Inc. AnnuloFlo Mitral Annuloplasty Device Size 36 Model AR-736 Titanium Sulzer Carbomedics, Inc., www.sorin.com It is designed to emulate the look and performance of a natural erection. The spring-loaded clip offers a gentle, but secure fit onto the stapes head. Magnetic Resonance Imaging (MRI) Safety Information for Zimmer Implants. The NiTiBOND Stapes Prosthesis manufactured by Heinz Kurz GmbH is /\R Conditional. Copyright © 2021 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. It ensures a secure fit on the stapes head and thus enhances safety for a good postoperative outcome. 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. Nickel allergy and thus enhances safety for a broad variety of reconstruction demands of. Testing has demonstrated the products listed below are MR Conditional rare, illustrating the safety of MRI with middle... Pdf-Format here > > this is a webpage for medical professionals was to. These specifically identified lots of McG … MRI scanners and the stapes.! Middle ear implants J Med Liban superior imaging qualities compared to fluoroplastic but present magnetic dipole moment the loop close! 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