Important Safety Information
MRI INFORMATION & PATIENT INFORMATION GUIDE
Caution: In the United States, the Corvia® Atrial Shunt System is an investigational device, limited by United States law to investigational use.
MAGNETIC RESONANCE (MR) IMAGING INFORMATION
Non-clinical testing demonstrated that the Corvia Atrial Shunt is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:
- Static magnetic field of 1.5-Tesla and 3-Tesla, only
- Maximum spatial gradient magnetic field of 4,000-Gauss/cm (40-T/m) or less
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of <2 W/kg (Normal Operating Mode)
Under the scan conditions defined, the Corvia Atrial Shunt is expected to produce a maximum temperature rise of 2.4°C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the Corvia Atrial Shunt extends approximately 5mm from this device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system. The device shunt lumen cannot be visualized on T1-weighted, spin echo and gradient echo pulse sequences.
PATIENT INFORMATION GUIDE
If you have already received the Corvia Atrial Shunt and want more information about your implant, you may download the Patient Information Guide.