The Penumbra SMART COIL System is comprised of COMPLEX and WAVE ™ coils designed for framing, filling, and finishing intracranial aneurysms and embolising vascular malformations. SMART coils have varying levels of softness, Standard, Soft, and Extra Soft. All coils within the Penumbra SMART COIL System feature an Ultra HD Fiber designed to provide stretch resistance, durability, and flexibility at the coil/pusher interface. Penumbra SMART COIL also features an instant, single-click mechanical detachment system for ease of use.
Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use.
PENUMBRA SMART COIL System – Intended Use
The PENUMBRA SMART COIL System is intended for the embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature
Potential Adverse Events
Possible complications include, but are not limited to, the following:
acute occlusion; air embolism; allergic reaction and anaphylaxis from contrast media; aneurysm rupture; arteriovenous fistula; coagulopathy; coil herniation into parent vessel; death; device malfunction; distal embolization; emboli; embolic stroke and other cerebral ischemic events; false aneurysm formation; hematoma or hemorrhage at access site of entry; incomplete aneurysm occlusion; infection; intima dissection; intracranial hemorrhage; ischemia; myocardial infarction; neurological deficits including stroke; parent artery occlusion; peripheral thromboembolic events; post-embolization syndrome; premature device detachment; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation.
- Multiple softness levels: Standard, Soft, Extra Soft
- Instant, single-click mechanical detachment
- Compatible with .0165″ (.42 mm) and .017″ (.43 mm) inner diameter microcatheters
- Coil sizes range from 1 mm to 18 mm in diameter and 1 cm to 60 cm in length