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Clinical Trials

UPDATE: The Freedom® portable driver was U.S. FDA Approved June 26, 2014.

The Freedom® Portable Driver

The Freedom portable driver is the world's first wearable power supply for the SynCardia temporary Total Artificial Heart. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

 

Background:

Prior to the development of the Freedom driver, Total Artificial Heart patients in the U.S. were confined to the hospital because the only FDA-approved driver for powering the Total Artificial Heart weighed 418 pounds and was the size of a washing machine.

Due to the shortage of donor hearts and increasing demand, patients listed for a heart transplant often wait months, sometimes years before a matching donor heart is found.

Life for a stable Total Artificial Heart patient confined to the hospital is emotionally, physically and financially draining for them, their family and the hospital. Recovery at home greatly improves the patient’s quality of life, which positively influences their physical, mental and emotional health. Discharge also eliminates most in-hospital costs for this portion of patient care.

Through the IDE clinical study, stable Total Artificial Heart patients who meet discharge criteria may leave the hospital to wait for their matching donor heart at home and in their communities using the Freedom portable driver.

 

IDE Clinical Study: click images on the right to enlarge ››

Primary Outcome Measures:

  • The Freedom driver is a suitable pneumatic driver for stable
    Total Artificial Heart patients.
  • The Freedom driver can be safely used at home.

Enrollment: The trial may enroll 60 patients at up to 40 institutions (site expansion from 30 to 40 approved by the FDA on April 5, 2012). A minimum of 30 of these patients must be discharged home (30th patient discharged on April 24, 2012).

Endpoints:

  • Heart transplant
  • 90 days of Freedom driver support, at home or in the hospital
  • Death

 

Criteria:

Inclusion Criteria:

  • The Total Artificial Heart with the Freedom driver is indicated for use as a bridge to cardiac transplant in clinically stable cardiac transplant-eligible candidates who are implanted with the Total Artificial Heart.

Exclusion Criteria:

  • Patients who are not cardiac transplant-eligible.
  • Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas <1.7m2, or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) <10cm.
  • Patients who cannot be adequately anticoagulated on the Total Artificial Heart.

 

Driver Features:

  • The Freedom driver weighs 13.5 pounds, including two onboard batteries and a power adaptor.
  • The batteries are designed to be charged using a standard electrical outlet or the cigarette lighter adaptor in a car.
  • The driver is designed to be carried by the patient in the Freedom Backpack or Shoulder Bag.
  • The Freedom driver uses a "dark cockpit" design, meaning the driver only flashes a light and sounds an alarm when something requires the user's attention.
  • The Freedom driver is intended to be serviced by replacement via express delivery.
  • No onsite repair or inventory of parts is required by the hospital.

 

Trial Update: Enrollment and Patient Discharges

  • As of Oct. 31, 2013, 86 Total Artificial Heart patients have been enrolled in the clinical study (including five under Compassionate Use). Of these patients, 62 have been discharged from the hospital using the Freedom portable driver. Thirty is the minimum number of discharges required by the clinical study.

 

Freedom Patients in the News:

 

Introduction to the
Freedom® Portable Driver

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bigblue-freedom_small

The 13.5-pound Freedom driver system and the 418-pound "Big Blue" hospital driver.

 

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The Freedom driver weighs 13.5 pounds including two onboard lithium-ion batteries and power adaptor.

 

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The Freedom Backpack

 

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The Freedom Shoulder Bag

 
 

NEXT ›› Powering the Total Artificial Heart

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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