• Confident anchoring segment in high-flow vessels
• Soft packing segment for mechanical occlusion
• 3-14 mm devices
• 20-60 cm lengths

For POD Coils with nominal sizes ≤ 6 mm

The POD System is indicated for the embolization of:

• Intracranial aneurysms.

• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

• Arterial and venous embolizations in the peripheral vasculature.

For POD Coils with nominal sizes > 6 mm

The POD System is indicated for arterial and venous embolizations in the peripheral vasculature.

Contraindications

There are no known contraindications.

Warnings

The POD System should only be used by physicians who have received appropriate training in interventional techniques.

Precautions

• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or reuse may compromise the structural integrity of the device or increase the risk of contamination or infection leading to device failure and/or cross-infection and potential patient injury, illness, or death.

• Do not use kinked or damaged devices. Do not use opened or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor.

• Use prior to the “Use By” date.

• Use device in conjunction with fluoroscopic guidance.

• Do not advance or retract the device against resistance without careful assessment of the cause using fluoroscopy. If POD cannot be advanced or retracted, withdraw the device as a unit with the microcatheter.

• Moving or torquing the device against resistance may result in damage to the vessel or device.

• Maintain a constant infusion of an appropriate flush solution.

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.