Frequently Asked Questions
Do I need to disconnect the C-Pulse® System in a Code scenario?
No. The C-Pulse System can safely remain connected during defibrillation. This will not affect the efficacy of the defibrillation nor will it damage the C-Pulse. In a Code scenario, the C-Pulse alarm will most likely have sounded and stopped counter-pulsating. In this state, it will not affect CPR. With successful resuscitation turn off then back on to resume normal function.
How does having a C-Pulse implanted affect a patient’s status on the transplant list
Having a C-Pulse implant does not affect a patient’s status on the transplant list. It will not raise their priority on the list, nor will it disqualify them from the list.
Will the patient need to take anti-coagulants with the C-Pulse implanted?
No. The C-Pulse is a non-blood contacting system, therefore, anti-coagulants are not required. They are not contra-indicated and many patients do continue such therapy to address other conditions such as AF at the discretion of their cardiologist.
Is the C-Pulse a destination therapy or a bridge therapy?
The C-Pulse is not specifically identified as either a destination therapy or a bridge therapy. The device is currently in a FDA approved IDE feasibility trial. Part of this trial is to better understand the potential outcomes for the patients. The C-Pulse is a Heart Assist Device
What is the expected operational life of the C-Pulse device?
The implanted components of the C-Pulse are specified for at least 4 years continuous operation. The external components are specified for at least 1 year’s continuous operation. We are continuing to collect data and plan to have the cuff at a 5 year life expectancy when the pivotal trial starts.
Can the patient take a commercial airline flight with the C-Pulse System?
C-Pulse is designed to operate in a commercial aircraft. The C-Pulse can be left on during flight (while ascending, in flight or descending). In the event you turn off the device during flight, you must disconnect the PIL from the Driver. Please note, experience is limited.
Will a cell phone interfere with the C-Pulse System?
Some patients have reported brief instances of interference when some brands of cell phones are kept close to the C-Pulse Driver. This interference may set off the driver alarm and may stop the system from performing. You may reset the driver by turning the Driver off and then back on. You should keep cell phones as far away from the Driver as possible.
Is there a car charger available for the C-Pulse System?
There is not a car charger currently available for the C-Pulse System. However, the patient will have 4 battery packs. If they are planning an extended car trip they should fully charge all battery packs before departure and carry them in the car.
Is the C-Pulse MRI compatible?
The C-Pulse is not MRI compatible.
How can I tell the C-Pulse System is working?
The C-Pulse System is working when the green light is on. If you hold the gas line you can feel the pulsation. Correct C-Pulse function can be detected by a double pulse at the wrist or by using arterial line or plethysmography wave form augmentation.
Can I assess the C-Pulse timing without the Programmer?
Yes. Timing can be assessed by using plethysmography, arterial line, ECHO, doppler ultrasound or tonometry. If changes are needed, the programmer must be connected.
How do I get real-time assistance with the Programmer and timing?
The 24-hour clinical support number is +1-877-742-7857 (North America) and +61 2 8424 7730 (Australia)
Can the patient have a CABG after C-Pulse implantation?
Yes. They can also have other surgeries such as a transplant, VAD or valve replacement.
Can the patient have a LIMA prior to C-Pulse implantation?
Yes. Intact aortocoronary artery grafts are a contraindication.
Can I implant a patient that has an ICD or CRT?
Yes. However, an ICD needs to be implanted for a minimum of 30 days prior to enrollment and a CRT needs to be implanted for a minimum of 90 days prior to enrollment.
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