Standalone
Sapphire Detachable Fibered Coil System
Indications for Use
Sapphire Detachable Coils (Non-Fiber): The Sapphire Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use. Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.
Key Specifications
- Manufactured from platinum alloy wire
- Wound into primary coil and formed into secondary helical shape
- Welded to positioning wire consisting of ground stainless steel core wire with stainless steel coil laser welded at distal end and Teflon outer jacket
- Detached by battery-operated power supply (Sapphire Detachment System, SDS) that dissolves a small detachment element
- Fibered with nylon fibers secured into the primary coil
- Available in two shapes: Helix and Cyclone
- Available in different sizes
- MRI compatible with 1.5 Tesla
Description
The Sapphire Detachable Coil (SDC) is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. The coil is welded to a positioning wire, which consist of ground stainless steel core wire with a stainless steel coil laser welded at the distal end and a Teflon outer jacket. The coil is detached by the battery operated power supply (Sapphire Detachment System, SDS), which dissolves a small detachment element between the embolization coil and the positioning wire. The fibered coil is manufactured with nylon fibers secured into the primary coil. The fibered coils are available in two shapes (Helix and Cyclone) and different sizes.