untitled

GDC® Detachable Coils Neurovascular Aneurysm Occlusion

Boston Scientific Corporation 510.440.7700 www.bostonscientific.com/neuro

Comprehensive Solutions for Aneurysm Treatment Only Boston Scientific offers a full complement of products for neurovascular embolization of aneurysms. Our extensive selection of GDC Coil designs and sizes, available in 10 and 18 delivery platforms, provides a choice of over 200 treatment options.

The Gold Standard The pioneer in minimally invasive aneurysm treatment, GDC Coils were also the only coils that went through a clinical trial. Today, they continue to lead, with more physicians choosing to treat patients with GDC Coils than all other coils combined. Proven Performance Since its introduction over a decade ago, physicians have selected GDC Coils to treat more than 150,000 patients worldwide. This clinical record represents the deployment of more than 1 million coils. Complete Coiling With the broadest selection of softness and sizes available, the GDC family is the most complete set of solutions for aneurysm treatment. From framing to finishing, firm to flexible, there is a coil for every case. Motion-Free Detachment All GDC Coils utilize an exclusive electrolytic detachment process for coil deployment The process does not rely on mechanical motion, resulting in precise, motion-free detachment.



GDC–10 360° Standard SR

Product Big Loop Length in Number O.D. (mm) Introducer (cm) 346305-SR ............................................ 3..............................................................5 346308-SR ............................................ 3..............................................................8 346407-SR ............................................ 4..............................................................7 346509-SR ............................................ 5..............................................................9 346515-SR ............................................ 5.............................................................15 346611-SR ............................................ 6.............................................................11 346615-SR ............................................ 6.............................................................15 346715-SR ............................................ 7.............................................................15 346720-SR ............................................ 7.............................................................20 346815-SR ............................................ 8.............................................................15 346820-SR ............................................ 8.............................................................20 346920-SR ............................................ 9.............................................................20 346930-SR ............................................ 9.............................................................30 3461030-SR ......................................... 10............................................................30 3461130-SR ......................................... 11............................................................30 3461230-SR ......................................... 12............................................................30 3461330-SR ......................................... 13............................................................30 3461430-SR ......................................... 14............................................................30 3461530-SR ......................................... 15............................................................30 3461540-SR ......................................... 15............................................................40



GDC–10 360° Soft SR

Product Big Loop Length in Number O.D. (mm) Introducer (cm) 347306-SR ............................................ 3..............................................................6 347408-SR ............................................ 4..............................................................8 347509-SR ............................................ 5..............................................................9 347611-SR ............................................ 6.............................................................11 347715-SR ............................................ 7.............................................................15 347820-SR ............................................ 8.............................................................20 347920-SR ............................................ 9.............................................................20 3471020-SR ......................................... 10............................................................20 3471120-SR ......................................... 11............................................................20 3471220-SR ......................................... 12............................................................20 3471322-SR ......................................... 13............................................................22 3471423-SR ......................................... 14............................................................23

GDC–18 360° Standard

Product Big Loop Length in Number O.D. (mm) Introducer (cm) 348615 .................................................. 6.............................................................15 348715 .................................................. 7.............................................................15 348820 .................................................. 8.............................................................20 348920 .................................................. 9.............................................................20 3481030 ............................................... 10............................................................30 3481130 ............................................... 11............................................................30 3481230 ............................................... 12............................................................30 3481330 ............................................... 13............................................................30 3481430 ............................................... 14............................................................30 3481630 ............................................... 16............................................................30 3481640 ............................................... 16............................................................40 3481830 ............................................... 18............................................................30 3481840 ............................................... 18............................................................40 3482033 ............................................... 20............................................................33 3482240 ............................................... 22............................................................40 3482440 ............................................... 24............................................................40



GDC–10 3D Shape

Product Big Loop Length in Number O.D. (mm) Introducer (cm) 345304-4 ............................................... 3..............................................................4 345306-4 ............................................... 3..............................................................6 345406-4 ............................................... 4..............................................................6 345408-4 ............................................... 4..............................................................8 345508-4 ............................................... 5..............................................................8 345510-4 ............................................... 5.............................................................10 345610-4 ............................................... 6.............................................................10 345615-4 ............................................... 6.............................................................15 345712-4 ............................................... 7.............................................................12 345715-4 ............................................... 7.............................................................15 345820-4 ............................................... 8.............................................................20 345103-4 .............................................. 10............................................................30

GDC–18 3D Shape

Product Big Loop Length in Number O.D. (mm) Introducer (cm) 355615-4 ............................................... 6.............................................................15 355825-4 ............................................... 8.............................................................25 355103-4 .............................................. 10............................................................30 355123-4 .............................................. 12............................................................30 355143-4 .............................................. 14............................................................30 355163-4 .............................................. 16............................................................30 355183-4 .............................................. 18............................................................30 355203-4 .............................................. 20............................................................30



GDC–10 2-Diameter*

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 342308-4 ............................................... 3..............................................................8 342410-4 ............................................... 4.............................................................10 342515-4 ............................................... 5.............................................................15 342620-4 ............................................... 6.............................................................20 342725-4 ............................................... 7.............................................................25 342830-4 ............................................... 8.............................................................30 342930-4 ............................................... 9.............................................................30 342103-4 .............................................. 10............................................................30

GDC–18 2-Diameter

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 352520-4 ............................................... 5.............................................................20 352620-4 ............................................... 6.............................................................20 352730-4 ............................................... 7.............................................................30 352830-4 ............................................... 8.............................................................30 352930-4 ............................................... 9.............................................................30 352103-4 .............................................. 10............................................................30 352123-4 .............................................. 12............................................................30 352143-4 .............................................. 14............................................................30 352163-4 .............................................. 16............................................................30 352183-4 .............................................. 18............................................................30 352203-4 .............................................. 20............................................................30

* First 1.5 loops are 75% of the stated Helical Coil Diameter (mm)



GDC–10 Standard

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 340204-4 ............................................... 2..............................................................4 340208-4 ............................................... 2..............................................................8 340304-4 ............................................... 3..............................................................4 340306-4 ............................................... 3..............................................................6 340308-4 ............................................... 3..............................................................8 340312-4 ............................................... 3.............................................................12 340406-4 ............................................... 4..............................................................6 340410-4 ............................................... 4.............................................................10 340510-4 ............................................... 5.............................................................10 340515-4 ............................................... 5.............................................................15 340610-4 ............................................... 6.............................................................10 340620-4 ............................................... 6.............................................................20 340710-4 ............................................... 7.............................................................10 340730-4 ............................................... 7.............................................................30 340810-4 ............................................... 8.............................................................10 340820-4 ............................................... 8.............................................................20 340830-4 ............................................... 8.............................................................30 340915-4 ............................................... 9.............................................................15 340930-4 ............................................... 9.............................................................30 340103-4 .............................................. 10............................................................30

GDC–18 Standard

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 350515-4 ............................................... 5.............................................................15 350520-4 ............................................... 5.............................................................20 350620-4 ............................................... 6.............................................................20 350730-4 ............................................... 7.............................................................30 350820-4 ............................................... 8.............................................................20 350830-4 ............................................... 8.............................................................30 350915-4 ............................................... 9.............................................................15 350930-4 ............................................... 9.............................................................30 350103-4 .............................................. 10............................................................30 350123-4 .............................................. 12............................................................30 350143-4 .............................................. 14............................................................30 350163-4 .............................................. 16............................................................30 350183-4 .............................................. 18............................................................30 350203-4 .............................................. 20............................................................30



GDC–10 Soft

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 341202-4 ............................................... 2..............................................................2 341203-4 ............................................... 2..............................................................3 341204-4 ............................................... 2..............................................................4 341206-4 ............................................... 2..............................................................6 341208-4 ............................................... 2..............................................................8 341303-4 ............................................... 3..............................................................3 341304-4 ............................................... 3..............................................................4 341306-4 ............................................... 3..............................................................6 341308-4 ............................................... 3..............................................................8 341310-4 ............................................... 3.............................................................10 341404-4 ............................................... 4..............................................................4 341406-4 ............................................... 4..............................................................6 341408-4 ............................................... 4..............................................................8 341410-4 ............................................... 4.............................................................10

GDC–18 Soft

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 351204-4 ............................................... 2..............................................................4 351208-4 ............................................... 2..............................................................8 351304-4 ............................................... 3..............................................................4 351308-4 ............................................... 3..............................................................8 351406-4 ............................................... 4..............................................................6 351410-4 ............................................... 4.............................................................10 351508-4 ............................................... 5..............................................................8 351512-4 ............................................... 5.............................................................12 351610-4 ............................................... 6.............................................................10 351615-4 ............................................... 6.............................................................15



GDC–10 Soft SR 2D*

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 344302-SR4 .......................................... 3..............................................................2 344303-SR4 .......................................... 3..............................................................3 344304-SR4 .......................................... 3..............................................................4 344306-SR4 .......................................... 3..............................................................6 344308-SR4 .......................................... 3..............................................................8 344403-SR4 .......................................... 4..............................................................3 344404-SR4 .......................................... 4..............................................................4 344406-SR4 .......................................... 4..............................................................6 344408-SR4 .......................................... 4..............................................................8 344504-SR4 .......................................... 5..............................................................4 344506-SR4 .......................................... 5..............................................................6 344508-SR4 .......................................... 5..............................................................8 344510-SR4 .......................................... 5.............................................................10 344606-SR4 .......................................... 6..............................................................6 344608-SR4 .......................................... 6..............................................................8 344610-SR4 .......................................... 6.............................................................10 344710-SR4 .......................................... 7.............................................................10 344715-SR4 .......................................... 7.............................................................15

* First 1.5 loops are 75% of the stated Helical Coil Diameter (mm)

GDC–10 Soft SR

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 341201-SR4 .......................................... 2..............................................................1 341202-SR4 .......................................... 2..............................................................2 341203-SR4 .......................................... 2..............................................................3 341204-SR4 .......................................... 2..............................................................4 341206-SR4 .......................................... 2..............................................................6 341208-SR4 .......................................... 2..............................................................8



GDC–10 UltraSoft®

Product Helical Coil Length in Number Diameter (mm) Introducer (cm) 343201 .................................................. 2..............................................................1 343202 .................................................. 2..............................................................2 343203 .................................................. 2..............................................................3 343204 .................................................. 2..............................................................4 343206 .................................................. 2..............................................................6 343252 .................................................2.5 ............................................................2 343253 .................................................2.5 ............................................................3 343254 .................................................2.5 ............................................................4 343256 .................................................2.5 ............................................................6 343304 .................................................. 3..............................................................4 343306 .................................................. 3..............................................................6 343308 .................................................. 3..............................................................8 343404 .................................................. 4..............................................................4 343406 .................................................. 4..............................................................6 343408 .................................................. 4..............................................................8

GDC Accessories Description Product Number Boston Scientific Detachable Coil Power Supply, 1 Each............................................................................................. 451007-4 Boston Scientific Detachable Coil Power Supply Connecting Cables, 1 Set Each ....................................................... 451102-4 GDC Batteries, 1 Box of 12 .......................................................................................................................................... 450003



See package insert for complete indications, contraindications, warnings, and instructions for use.

GDC Detachable Coils Indications for Use GDC Coils are intended for embolization of those 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. GDC Coils are also intended for embolization or other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. GDC Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

Contraindications None known.

Potential Adverse Effects Potential complications include, but are not limited to: post embolization syndrome, hematoma, hemorrhage, vessel perforation, emboli (foreign, thromboembolic), ischemia, vasospasm, revascularization, inadequate occlusion, and neurological deficits including stroke and possibly death. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions/Precautions • Federal law (USA) restricts this device to sale by or on the order of a physician. • This device should be used by physicians trained in interventional neuroradiology or interventional radiology and who have undergone preclinical training in

all aspects of GDC procedures as prescribed by Boston Scientific. • Only GDC-18 Coils should be delivered through Boston Scientific "-18" 2-tip Infusion Catheter. Only GDC-10 Coils and GDC-10 Soft Coils should be

delivered through Boston Scientific "-10" Infusion Catheters. If advanced through a Boston Scientific "-18" catheter, the GDC-10 coil could fold back upon itself resulting in jamming, stretching or breaking.

• The GDC is designed to be delivered through a Boston Scientific 2-tip Infusion Catheter. The compatibility of the GDC system with other catheters and with other coil delivery devices has not been established.

• In order to achieve optimal performance of the GDC Coils and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip infusion and guiding catheters, and c) the 2-tip infusion catheter and Boston Scientific guidewires and GDC delivery wire. Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the GDC detachment zone.

• Advance and retract the coil slowly and smoothly, especially in tortuous anatomy. Remove the coil if unusual friction or "scratching" is noted. If friction is noted in a second coil, carefully examine both coil and the catheter for possible damage such as catheter shaft buckling or kinking, or improperly fused joint.

• Do not advance the coil with force if the coil becomes lodged within or outside the 2-tip infusion catheter. Determine the cause of resistance and remove the system when necessary.

• If resistance is encountered when withdrawing the delivery wire, draw back on the infusion catheter simultaneously until the delivery wire can be removed without resistance.

• If resistance is noted during coil delivery, remove the catheter/coil system and check for possible damage to the catheter. • Do not use power sources other than the Boston Scientific battery operated power supply specifically built for Boston Scientific. • Do not sterilize the power supply. • Verify that the power supply leads have not been inverted at the patient site. If polarity is reversed, GDC will not detach. • Incorrect placement of batteries could result in unit malfunction. • Do not use if sterile packaging has been breached or damaged. • Once the detachment of the coil has been signaled, verify under fluoroscopy that the coil has detached: slowly pull back on the delivery wire while watching

fluoroscopy to make sure the coil does not move. In the unlikely event the coil moves, allow more time for detachment. • Multiple embolization procedures may be required to achieve the desired occlusion of some aneurysms or vessels • If resistance is encountered while withdrawing a GDC coil which is at an acute angle relative to the catheter tip, it is possible to avoid coil stretching or

breaking by carefully repositioning the distal tip of the catheter at the ostium of the aneurysm, or just slightly inside the parent artery. By doing so, the aneurysm and artery act to "funnel" the coil back into the catheter.

• The safety and performance characteristics of the GDC System (GDC Detachable Coils, Boston Scientific Detachable Coils power supply, delivery systems, and accessories), when used with another manufacturer's devices (whether coils, coil delivery devices, catheters, guidewires, and/or other accessories) has NOT been established. Due to the potential incompatibility of non-Boston Scientific components with the GDC System, the use of another manufacturer's devices(s) with the GDC System is not recommended.



Warnings • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston

Scientific representative. • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device

and/or lead to device failure which, in turn, may result in patient injury, illness or death; Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. Increased detachment times may occur when: • Tungsten and/or other non-platinum coils are already present within the aneurysm. It is therefore recommended that the GDC Coils not be used in the presence

of non-platinum coils. • Other embolic agents are present. • Delivery wire/catheter markers are not properly aligned. • GDC connecting cables have been resterilized. The GDC connecting cables are supplied for one use only and should be discarded after each procedure. • Damaged delivery wires may cause vessel injury or unpredictable distal tip response during coil deployment. • Utilization of damaged coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration and/or stretching. • Do not rotate delivery wire during or after delivery of the coil into the aneurysm. Rotating the GDC delivery wire may result in stretched coil or premature

detachment of the coil from the delivery wire which could result in coil migration. • Verify repeatedly that the distal shaft of the catheter is not under stress before detaching the GDC coil. Axial compression or tension forces could be stored in

the 2-tip infusion catheter causing the tip to move during the coil delivery. Catheter tip movement could cause the aneurysm or vessel to rupture. • Advancing the delivery wire beyond the catheter tip once the coil has been detached involves risk of aneurysm or vessel perforation. • If undesirable movement of the coil can be seen under fluoroscopy following coil placement and prior to detachment, remove the coil and replace with another

more appropriately sized coil. Movement of the coil may indicate the coil could migrate once it is detached. Angiographic controls should also be performed prior to detachment to ensure that the coil mass is not protruding into the parent vessel.

• Connecting cables are intended for one use only. Do not resterilize and/or reuse. Resterilization could corrode the connecting cables, resulting in increased detachment times.

• Dispose of used connecting cables and coil devices in accordance with hospital administrative and/or local government policy. • High quality, digital subtraction fluoroscopic road mapping is mandatory to achieve safe catheterization of the aneurysm or vessel and correct placement of the

first coil. With smaller aneurysms this is particularly important. • If coil repositioning is necessary, take special care to retract coil under fluoroscopy in a one-to-one motion with the delivery wire. If the coil does not move

with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break. Gently remove and discard both the catheter and coil.

• Due to the delicate nature of the coils, the tortuous vascular pathways which lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential malfunctions, such as coil breakage and migration.

• Take care not to puncture gloves or sterile drape while handling the delivery wire. • The long term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.



See package insert for complete indications, contraindications, warnings, and instructions for use.

Boston Scientific Detachable Coil Power Supply Indications for Use The Boston Scientific Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature. Refer to GDC Package Insert for use in the clinical setting.

Contraindications None known.

Warnings None known.

Potential Adverse Effects No Potential Adverse Effects are described in the Package Insert. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated. Refer to the GDC Package Insert for Potential Adverse Effects for the GDC. Cautions/Precautions • Federal law (USA) restricts this device to sale by or on the order of a physician. • A second, back-up Power Supply and two fresh batteries are required for all procedures. • Incorrect placement of batteries will prevent unit from operating. • Store in a cool, dry place. • Do not sterilize Power Supply. • Do not submerge Power Supply. Damage to the system could result. • Use only a cloth dampened with alcohol to clean the plastic surface of the Power Supply. Avoid all types of detergents, cleaners, or solvents which might

contain chemicals that could seriously damage the plastic or leave contaminating residues. • Do not remove cover (or back) from Power Supply. Service, if necessary, must be performed by qualified personnel at Boston Scientific. Preventive

Maintenance should be performed twice per year if otherwise not in use. • The safety and performance characteristics of the GDC System (GDC coils, Power Supply, delivery systems and accessories), when used with another

manufacturer's devices (whether coils, coil delivery devices, catheters, guidewires, and/or other accessories) has NOT been established. Due to the potential incompatibility of non-Boston Scientific components with the GDC System, the use of another manufacturer's devices(s) with the GDC System is not recommended.

Trademark GDC and GDC–10 Ultrasoft are trademarks of Boston Scientific Corporation or its affiliates.

Documents

untitled