Parachute Heart Failure Treatment

Heart Failure Treatment Procedure

MRI

MR Conditional
Non-clinical testing has demonstrated that the PARACHUTE Implant is MR conditional. A patient with this device can be scanned immediately after placement under the following conditions:

 

Static Magnetic Field
Static magnetic field strength of 3-Tesla or less
Maximum spatial gradient magnetic field of 720 Gauss/cm


MRI-Related Heating

In non-clinical testing, CardioKinetix PARACHUTE produces temperature rises during MRI performed for 15 minutes of scanning (i.e., per pulse sequence) in 1.5-Tesla/64-MHz and 3-Tesla/128-MHz MR systems:

 

MR System reported whole body averaged SAR: 2.9-W/kg 1.5-Tesla & 3-Tesla
Calorimetry values for whole body averaged SAR: 2.1-W/kg (1.5-Tesla)/2.7-W/kg (3-Tesla)
Highest temperature change: +1.9o C (1.5-Tesla)/+2.1o C (3-Tesla)


Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of PARACHUTE Implant. Optimization of MR imaging parameters to compensate for the presence of this device may be necessary. The maximum artifact size extends approximately 5-mm relative to size and shape of the implant.

 

  • Pulse SequenceT1-SET1-SEGREGRE
  • Signal Void Size1,898-mm2339-mm25045-mm21,123-mm2
  • Plane OrientationParallelPerpendicularParallelPerpendicular