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.

Translations available:

MR Safety Information: Non-clinical testing has demonstrated that the NeoChord System is MR Conditional. A patient implanted with the device may be safely scanned under the conditions as outlined below.

Failure to follow these conditions may result in injury to the patient. If information about a specific parameter is not included, there are no conditions associated with that parameter.

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.

CONTACT

(952) 698-7800

info@neochord.com

NeoChord, Inc
5402 Parkdale Drive,
Suite 160 St. Louis Park,
MN 55416