Coils
Numen Coil Embolization System
Indications for Use
Numen Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen Coil Embolization System is indicated for endovascular embolization of: Intracranial aneurysms; Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae; Arterial and venous embolizations in the peripheral vasculature. NumenFR Detachment System is intended for use with MicroPort NeuroTech Numen Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
Key Specifications
- Introducer sheath material: HDPE
- Coil system composed of pusher and coil implant
- Coil is a permanent implant to occlude blood flow
- Secondary shape: 3D, Helical
- Stretch resistance: Yes
- Coil secondary diameter: 1-24 mm
- Coil length: 1-70 cm
- Pusher length: 183.5 cm
- Coil material: Pt (92%) / W (8%)
- Stretch resistant thread: Polypropylene
- Pusher body hypotube: SS 304
- Detachment mechanism: Electrolytic
- Sterile, for single use only
- Sterilization method: Ethylene Oxide
- Used with NumenFR Detachment System (separate): handheld, dimensions 140.0 mm × 45.0 mm × 28.0 mm, weight 65.0g - 75.0g, power source two 1.5 V AAAA DC alkaline batteries in series, max voltage 28 V DC, max current 1.8 mA, max time per cycle 10 seconds, minimum 20 detachments
Description
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts: An introducer sheath to facilitate introduction of the coil into the microcatheter, and the coil system composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.