MR Safety

Heinz Kurz GmbH Medizintechnik manufactures implants for surgeons specializing in otorhinolaryngology. These are designed for permanent implantation in the patient.

Examinations with magnetic resonance imaging (MRI) tec niques are employed increasingly for all types of diagnostic purposes. Potential hazards that MRI imaging may have as a resul of the implant included magnetic field interactions, heating, induced electrical currents, and artifacts.

To ensure patient safety in accordance with regulatory requirements and, above all, with our concern for users of our products, KURZ™ has employed leading MRI safety-testing companies, such as Shellock1 to verify all aspects of MRI safety. This includes the d gree of magnetic field interaction that occurs with our implants throughout the relevant range of Tesla intensities as well as the maximum Tesla strength to which they may be safely exposed. The table below specifies the maximum Tesla strength for which each implant has been safety-tested.

In addition, many peer-reviewed clinical studies have evaluated the potential risks that might be caused by exposing ENT implants to MRI procedures. Most of these have included KURZ™ implants in their testing (see list of publications below).

• Behavior of metal implants used in ENT surgery in 7 Tesla magnetic resonance imaging

  Thelen A; Bauknecht HC; Asbach P; Schrom T
  Eur Arch Otorhinolaryngol. 2006 Oct; 263(10):900-5
  Epub 2006 Jul 12.

• How do Metallic Middle Ear Implants behave on MRI?

  Kwok P; Waldeck A; Strutz J
  Laryngorhinootologie. 2003 Jan; 82(1):13-8.

• Safety Evaluation of Titanium Middle Ear Prostheses at 3.0 Tesla

  Martin AD; Driscoll CL; Wood CP; Felmlee JP
  Otolaryngol Head and Neck Surg. 2005 Apr;132(4):537-42

• Safety of Magnetic Resonance Imaging of Stapes Prostheses

  Mark JS
  Laryngoscope 115: March 2005

• Ferromagnetic movements of middle ear implants and stapes prostheses in a 3-T magnetic resonance field

  Fritsch MH; Gutt JJ
  Otol Neurotol. 2005 Mar; 26(2):225-30