Taewoong Medical Co., Ltd. - Niti-S SPAXUS™ Stent

MRI Safety information for:

Niti-S SPAXUS™ Stent

Conditional

Taewoong Medical Co., Ltd.

Polymer-metal oesophageal stent

Niti-S stent was determined to be MR-conditional. Non-clinical testing and MRI simulations were performed to evaluate the entire family of the Niti-S SPAXUS Stent. Non-clinical testing demonstrated that the entire family of the Niti-S SPAXUS™ Stent is MR Conditional. A patient with a device from this family can be scanned safely in an MR system under the following conditions: