The Kapsus is stored unsheathed. Prior to starting the procedure, the distal part of the handle is extended to sheath the housing. The device is now ready for introduction.
Once the tip is located in the right atrium with the available imaging equipment (e.g. fluoroscopy), the device is rotated to a 5 o’clock position by using the orientation indicator as a reference. Subsequently, the SVC anchor can be unsheathed and anchored in the superior vena cava. This is accomplished by sliding back the distal portion of the handle until the SVC anchor can be seen with the imaging equipment.
After rotating to a 5 o'clock position and anchoring the device in the superior vena cava, the rest of the housing can be deployed in the right atrium by sliding back the distal part of the handle into its initial position.
Once the device is completely anchored, the physician uses their thumb to prime the needle with the priming wheel. This action may be used for tenting the fossa ovalis and finding the desired angle of attack for puncture.
While maintaining the position of the priming wheel, the safety lock is removed with the right hand. The blue section is then held in place for safety reasons; the device is now ready and the physician can perform the puncture.
To engage the needle, the blue section is pushed until the grey stop. This is a safety measure preventing the needle from traveling too far into the left atrium.
Subsequently, the guide wire is inserted through the luer connector at the proximal end of the device.
Finally, the device is retrieved. The physician holds the distal section of the handle in place while pulling the blue part backwards until the housing is completely sheathed. While continuing to pull the blue section, the physician may release the distal section and pull the remainder of the device out of the patient’s body.
The Kapsus device for transseptal puncture is an investigational device not available for sale at this time.
Bavaria Medizin Technologie GmbH (BMT) is part of the Lubrizol Life Science business group.