Device Dossier

CONCERTO™ Detachable Coils (PGLA Helix) - Non-neurovascular embolization coil

Device Dossier for CONCERTO™ Detachable Coils (PGLA Helix) - Non-neurovascular embolization coil (Non-neurovascular embolization coil, Class III, sponsor…

Intended purpose

The device is indicated for arterial and venous embolisms in the peripheral vasculature.

Functional description

The CONCERTO™ Detachable Coil consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (Instant Detacher) which when activated detaches the coil from the delivery pusher tip. This CONCERTO Detachable Coils are enlaced with PGLA fibers.

TGA Public Summary