• “Liquid metal” coil designed to conform to a variety of vessel sizes.
• Packs densely behind a POD or Ruby Coil backstop.
• Large Volume System.
• High-flow microcatheter compatible (.025 – .027″ ID).
• 5 – 60 cm lengths.
• LP System lengths.
• Low-profile microcatheter compatible (.0165 – .021″ ID).
• 3 – 60 cm lengths.

The Penumbra LP Coil 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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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.

Contraindications

There are no known contraindications.

Warnings

• The Penumbra LP Coil System should only be used by physicians who have received appropriate training in interventional techniques.

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

• Do not advance or withdraw the device against resistance without careful assessment of the cause using fluoroscopy.

• If resistance is encountered when withdrawing the coil, withdraw the microcatheter until the resistance subsides.

• Do not rotate the delivery pusher during use. Rotating the delivery pusher may result in premature detachment, which could lead to coil damage, incorrect positioning, or vessel damage.

• Verify repeatedly that the microcatheter is not under stress before coil detachment. Stored forces in the microcatheter could cause the tip to move during detachment, which could lead to lesion rupture.

• Advancing the delivery pusher beyond the microcatheter tip could lead to lesion rupture.

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.

• Use prior to the “Use By” date.

• Use device in conjunction with fluoroscopic guidance.

• As in all fluoroscopy procedures, consider all necessary precautions to limit patient radiation exposure by using sufficient shielding, reducing fluoroscopy times and modifying radiation technical factors whenever possible.

• 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.

• The device may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective lesion treatment.

Potential complications include but are not limited to:

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; radiation exposure that may lead to cataracts, skin reddening, burns, alopecia, or neoplasia from x-ray exposure; recanalization; renal failure; respiratory failure; revascularization; thromboembolic episodes; vessel spasm, thrombosis, dissection, or perforation.