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The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The Micrus Modified MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micros Modified MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are available in helical and spherical shapes and are available in various diameters/lengths: Coil lengths range from 1 to 30 centimeters. Coil diameters range from 2 to 10 millimeters. Micrus Modified MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The difference between the Micros Modified MicroColl and the Micros Stretch Resistant MicroCoil is that the Modified MicroCoil and the MicroCoil contains absorbable polyglycolic acid (PGA) suture whereas the Stretch Resistant MicroCoil contains non-absorbable polypropylene suture. The Modified MicroCoils are available in both stretch resistant and non-stretch resistant configurations with different stiffness characteristics and stretch resistant properties.

The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.

The current Micros Spherical MicroCoil System (510k # K002056) is available in 10 and 18 system sizes. The 10 System Spherical MicroCoils are available in diameters ranging from 2 mm to 10 mm and in lengths ranging from 2 cm to 20 cm. The 18 System Spherical MicroCoils are available in diameters ranging from 2 mm to 19 mm and in lengths ranging from 2 cm to 30 cm. The proposed longer Spherical MicroCoil, which is the focus of this submission, is designed to provide move aneurysm-framing loops to provide better aneurysm wall and aneurysm neck coverage in aneurysms ranging from 6 to 10 mm in size: The "Long 10 System Spherical" MicroCoils will be available in diameters ranging from 6 mm to 10 mm and in lengths ranging from 20 cm to 30 cm. These long Spherical MicroCoils are a line extension of the current regular length Micrus Spherical MicroCoils. Both the original length and long length Spherical MicroCoil Systems are "framing" coils, to be used interchangeably to frame the inner wall of the aneurysm prior to filling it with Helical MicroCoils. All Micrus MicroCoils are part of the complete Micrus MicroCoil Delivery System, which has three components (sold and provided individually): 1) Micrus Platinum MicroCoil Systems, Spherical, Straight, and Stretch Resistant configurations, consist of an embolic coil attached to a variable stiffness Device Positioning Unit (DPU). The DPU has a radiopaque marker band located three (3) centimeters from its distal end for compatibility with infusion microcatheters with 2 tip markers. 2) Detachment Control Boxes (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE. 3) Connecting Cable. The Connecting Cable is used to bring the energy from the DCB to the MicroCoil System, and is approximately 5-ft (1.5 m) long.

The MicroCatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

The Micrus Microcatheter consists of 4 major components: - A flexible shaft with a lubricious liner extruded from Teflon. The liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax, - An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils. - A standard luer hub insert, which is molded onto the flexible shaft. - A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.

Micrus MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

Micrus MicroCoil Systems are platinum embolic coils ("MicroCoils") attached to Device Positioning Units (DPUs (single use, sterile). The Micrus MicroCoil Systems are available in a 10-System size (compatible with 10 and 14 sized microcatheters) and 18-System size (compatible with 14 and 18 sized microcatheters). Both 10 and 18 sizes are available in various diameters/dimensions. Shapes can be spherical, helical, or straight. Lengths range from 1 to 30 centimeters and diameters range from 2 to 20 millimeters. Implant material for the non stretch resistant MicroCoils is a platinum alloy: implant material for the stretch resistant MicroCoils is a platinum alloy and a stretch resistant member (non-absorbable polypropylene suture). A MicroCoil is detached from its Device Positioning Unit through heat shearing of a highly oriented, high tensile strength polyethylene (PE) fiber upon the clinician's command. The Device Positioning Unit is then removed from the microcatheter and discarded. A Micrus MicroCoil System connects to a Micrus Connecting Cable (single use, sterile) which traverses the sterile field to connect to a Micrus Detachment Control Box (DCB) (reusable, non-sterile). The Connecting Cable and Detachment Control Box are sold separately. A MicroCoil System plus Connecting Cable and Detachment Control Box is referred to as a Micrus MicroCoil Delivery System.

The Micrus Stretch-Resistant MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms that – because of their morphology, their location or the patient's general medical condition -- are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques or b) inoperable.

The Micrus Stretch Resistant MicroCoil System consists of a platinum embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micrus Stretch Resistant MicroCoil System connects to a Micrus Connecting Cable (single use, sterile) which traverses the sterile field to connect to a Micrus Detachment Control Box (DCB) (reusable, non-sterile). The Connecting Cable and Detachment Control Box are sold separately. The Micrus Stretch-Resistant MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are helically shaped and are available in various diameters/dimensions. Coil lengths range from 1 to 15 centimeters and diameters range from 2 to 10 millimeters. The Stretch Resistant MicroCoils are available in two levels of softness: 1. The Micrus Soft, Stretch-Resistant MicroCoil (catalog # FSR) corresponds to the 10-System GDC Ultra Soft Stretch Resistant Coil, using a primary wind of 0.0015" to create softness. 2. The Standard Micrus Stretch-Resistant MicroCoil (catalog # HSR) corresponds to the 10-System GDC Soft, Stretch Resistant coil, using a primary wind of 0.00175". Micrus Stretch Resistant MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing a non absorbable polypropylene suture inside the wind) and then formed into a secondary helical shape. The Micrus Stretch-Resistant MicroCoil System is identical to the FDAcleared MicroCoil System with the 4 following exceptions: 1. The coil's primary wind wire diameter has been reduced from 0.00175" to 0.0015" to create softness in the Micrus Soft Stretch-Resistant MicroCoil. (The Standard Micrus Stretch-Resistant MicroCoil uses the same 0.00175" diameter primary wind as is used in the Micrus 10-System Helical MicroCoil.) 2. A non absorbable polypropylene suture has been inserted inside the primary wind coil to create stretch-resistance. 3. The polypropylene suture is connected to the distal coil end to make a non-traumatic distal ball tip. 4. A loop of polypropylene suture has been added to the socket/ring connection at the coil to Device Positioning Unit junction to secure the polypropylene suture to the Device Positioning Unit.