MRI Statement

   MR Conditional

Non-clinical testing demonstrated that the V-Wave Ventura® Interatrial Shunt is MR Conditional. A patient with this device can be safely scanned in an MR system under the following conditions:

• Static magnetic field of 1.5 Tesla or 3-Tesla
• Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤2 W/kg (Normal Operating Mode)

Under the scan conditions defined, the V-Wave Ventura Interatrial Shunt is expected to produce a maximum temperature rise of 2°C after 15-minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the V-Wave Ventura Interatrial Shunt extends approximately 7-mm from this implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.

MP0011 Rev. 00 DCO 670.