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 Delivery Microcatheters – Intended Use
The Penumbra Delivery Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.
Potential Adverse Events
Possible complications include, but are not limited to, the following: acute occlusion; hematoma or hemorrhage at access site; death; intracranial hemorrhage; hemorrhage; infection (at access site); distal embolization; ischemia (cardiac and/or cerebral); embolus (air, foreign body, thrombus, plaque); aneurysm perforation; false aneurysm formation; neurological deficits including stroke; vessel spasm, thrombosis, dissection, perforation or rupture; air embolism; emboli.
Penumbra System – Intended Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease using continuous aspiration.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; 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