MRI Safety Information
Transcatheter Transseptal NeoChord NeXuS
Magnetic Resonance Safety Information for Clinical Research Patients
If you have been treated with the NeoChord System and you require Magnetic Resonance Imaging (MRI), the below MR Safety Information is important to share with your healthcare team. Your healthcare team will understand this information. You are not expected to understand this information.
MRI Safety Information
A person with an Anchor Subassembly device may be safely scanned anywhere in the body at 1.5 T or 3.0 T under the following conditions. Failure to follow these conditions may result in injury.
| Parameter | Condition |
|---|---|
| Device Name | Anchor Subassembly |
| Static Magnetic Field Strength (B0) | 1.5 T or 3.0 T |
| MR Scanner Type | Cylindrical |
| (B0) Field Orientation | Horizontal |
| Maximum Spatial Field Gradient | 40 T/m (4,000 G/cm) |
| RF Excitation | Circularly Polarized (CP) |
| RF Transmit Coil Type | Integrated Whole Body Transmit Coil |
| Operating Mode | Normal Operating Mode |
| RF Conditions | Maximum Whole-body SAR: 2 W/kg |
| Scan Duration | 1.5 T scanners: Up to 1 hour of continuous scanning without cooling period
3.0 T scanners: Up to 1 hour of continuous scanning without cooling period. |
| Scan Regions | All landmark locations are acceptable. |
| Image Artifact | The presence of an Anchor Subassembly device may produce an image artifact of 2.9 cm. Some manipulation of scan parameters may be needed to compensate for the artifact. |
NeoChord is a privately held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation.
NeoChord ConsultConnect and ConnectCARD is a medical consultation and service related to delivery of artificial chordae tendineae for treatment of mitral insufficiency. The NeoChord Artificial Chordae Delivery System, Model DS1000, meets the essential requirements referred to in Article 3 of the MDD 93/42/EEC and is labeled with the CE marking of conformity.
NEOCHORD, DS1000, RECHORD, NEOCHORD CONSULTCONNECT, CONNECTCARD, ACCHORD, ULTRACHORD, the stylized logos, and Transforming Mitral Valve Repair are registered trademarks or service marks of NeoChord, Inc.
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use.