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Medical Devices / Submissions and Approvals

Alcyone Lifesciences Gains Breakthrough Device Designation for ThecaFlex

March 13, 2019
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Alcyone Lifesciences earned a breakthrough device designation from the FDA for its ThecaFlex DRx system, indicated for patients aged three or older who need chronic bolus intrathecal treatment.

The device, which is made up of a subcutaneous port and an intrathecal catheter used to access cerebrospinal fluid, helps treat patients with life-threatening, debilitating central nervous system disorders.

The device is designed for patients who cannot undergo lumbar punctures due to spinal anomalies or who are resistant to lumbar punctures needed for therapy administration.

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