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FDA Clears SynCardia to Study Smaller Version of Total Artificial Heart.

M2 PHARMA-March 31, 2015-FDA Clears SynCardia to Study Smaller Version of Total Artificial Heart

(C)2015 M2 COMMUNICATIONS

US-based medical device maker SynCardia Systems, Inc. has received FDA approval to conduct an Investigational Device Exemption clinical study on the effective use of its 50cc SynCardia temporary Total Artificial Heart, the company said on Tuesday.

The FDA approval will allow SynCardia to launch the study with as many as 30 heart failure patients.

Patients enrolled in this study will receive the 50cc SynCardia Total Artificial Heart as a bridge to a donor heart transplant.

Under the study, the 50cc SynCardia Total Artificial Heart initially will be available for implantation in ten pediatric patients 10-18 years old, ten adult patients 19-75 years old and ten patients who would not otherwise qualify under the study criteria.

This secondary arm is expected to further characterize the use of the 50cc SynCardia Heart. All patients in the study must be eligible for donor heart transplant.

As part of the study and to better understand the patient populations that can benefit from the 50cc SynCardia Heart, images of the patients' chest cavities will undergo 3D modeling.

SynCardia said that its Total Artificial Heart is the only approved device that eliminates the source of end-stage biventricular heart failure in which the native heart's two ventricles can no longer pump enough blood for the patient to survive.

Study data through the first six months of patient use will be provided to the FDA as part of its review and approval process. Patients will be followed for up to two years to report on their experiences.

In Europe, both sizes of the SynCardia Total Artificial Heart have CE mark approvals for use as a bridge to donor heart transplant or as destination therapy, also known as permanent use. Use of the SynCardia Heart for destination therapy varies by country.

SynCardia Systems' Total Artificial Heart is used as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.

More than 1,400 implants of the SynCardia Total Artificial Heart account for over 400 patient years of life on the device. SinceJanuary 2010more than 550 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant.

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Publication:M2 Pharma
Date:Mar 31, 2015
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