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Intended for the endovascular embolization of: - Intracranial aneurysms. . - Other neurovascular abnormalities such as arteriovenous . malformations and arteriovenous fistulae. - Arterial and venous embolizations in the peripheral vasculature. .

The Boston Scientific Neurovascular Guglielmi Detachable Coil (GDCTM) is a device which facilitates endovascular embolization of intracranial aneurysms and other vascular abnormalities. The GDCTM Detachable Coil is a platinum/tungsten alloy coil attached to a stainless steel delivery wire. The GDCTM Detachable Coil is detached (using the GDCTM Power Supply) by electrolytically dissolving a small portion of the delivery wire upon its desired placement within an aneurysm or other vascular site via a microcatheter. Multiple coils can be delivered into an aneurysm or other vascular site through the same microcatheter until the aneurysm or other vascular site is densely packed.

Matrix Detachable 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 o) inoperable. Matrix Detachable Coils are also intended for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix Detachable Coils are also intended for arterial and venous ambolizations in the perioheral vasculature.

Matrix Stretch Resistant Detachable Coils are comprised of a platinum-tungsten alloy coil which is coated with a biocompatible absorbable polymer. Packaging of the device is identical to that of the predicate Matrix Detachable Coils: the finished device is loaded into an introducer sheath and is then placed in a dispenser coil contained within a foil pouch. The foil pouch is then placed into a cardboard display box with a copy of the instructions for use. Matrix Stretch Resistant Detachable Coils are detached using Boston Scientific's GDC® Power Supply. The system consists of the power supply, powered by two 9 volt batteries, an occlusion coil attached to a delivery wire, a set of connecting cables and a patient return electrode. A positive cable (red) supplies current to the delivery wire while a negative cable (black) completes the circuit by connecting to the patient return electrode (either an adhesive patch attached to the patient's skin or a hypodermic needle inserted subcutaneously through the patient's skin). After placement of the coil in the anatomy, detachment occurs through the clectrolytic dissolving of a small portion of the delivery wire.

GDC Coils (All Versions except GDC 18-Fibered VortX™ Shape): The Guglielmi Detachable Coil is 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. The GDC is also intended for embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. GDC 18-Fibered VortX Shape: This product is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. GDC-18 Fibered VortX Shape is also intended for arterial and venous embolizations in the peripheral vasculature.

Guglielmi Detachable Coils (GDC®) are used as part of a system indicated for endovascular occlusion in patients with high surgical risk intracranial aneurysms and other neurovascular abnormalities. The GDC system consists of the following items, each of which is sold separately - · GDC Power Supply - · GDC SynerG TM occlusion coil attached to a delivery wire - · set of GDC connecting cables - · patient return electrode - · two 9-volt batteries GDC SynerG coils are available in regular (secondary helical), 2D (secondary helical with distal helix) and 3D (tertiary) shapes, in a range of sizes, and in Standard, Soft and Stretch Resistant versions, all of which are compatible with Boston Scientific Target Infusion Catheters with two tip markers. GDC is also available as an UltraSoft™ Coil, developed to address physicians' requests for a softer Stretch Resistant coil and a wider range of coil sizes to treat intracranial aneurysms. Boston Scientific Target also offers a Fibered GDC device, GDC 18-Fibered VortX Shape, incorporating synthetic fibers through the main coil for a more rigid coil. All of the coils are manufactured from a platinum-tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, a coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC). The distal tip of the coil is welded to form a smooth tip (with the exception of Stretch Resistant GDC). The coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. Using fluoroscopic guidance and a guiding catheter to access the lesion, the physician delivers the GDC coil to the targeted site through an infusion catheter. Upon desired placement in the anatomy, the coil is detached by use of a battery-operated power supply designed specifically for use with the GDC system. The GDC SynerG Power Supply used to initiate and control detachment is a self-contained unit that applies a constant current through the GDC system until detachment is detected. Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting. After selecting a current setting and initiating detachment, the current flowing through the delivery wire begins to dissolve, by electrolysis, the exposed stainless steel at the junction with the platinum-tungsten coil. Over a period of several minutes, the exposed steel completely dissolves and the platinum-tungsten coil detaches. When coil detachment is detected, the GDC SynerG Power Supply immediately halts current flow, freezes the displays and emits an audible signal that coil detachment has occurred. Using fluoroscopy, the physician then verifies that the delivery wire can be withdrawn without disturbing the newly placed coil, and can resume electrolysis if necessary. Multiple GDC coils may be placed within a single aneurysm, at the discretion of the interventional team, to achieve optimum occlusion of the lesion.

The Atlantis TM PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ PV Imaging Catheter consists of two main assemblies: an over-the-wire (OTW) exchange style sheath assembly and an imaging core assembly. The sheath is comprised of the following three sections: Radiopaque soft tip, Proximal dual lumen, and Telescoping section. The imaging core is composed of a hi-torque flexible, rotating drive cable with a radially looking 15 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the MotorDrive Unit (MDU) / Instrument. A flush port with a one-way valve is used to displace air near the transducer. The catheter is for use with the BSS ClearView Ultra™ and Galaxy™ IVUS Imaging Systems.

The Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires.

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The 300cm length allows exchange of therapeutic devices without the use of other exchange devices, i.e. extension wires. The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire have a nominal diameter of 0.014". All device materials, manufacturing processes and product dimensions are identical to the Boston Scientific Scimed ChoICE™ ES 300cm exchange guidewire and the ChoICE™ 300cm Floppy exchange guidewire.

Boston Scientific Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific Target's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The GDC system consists of the following items, each of which is sold separately - · GDC Power Supply - · GDC occlusion coil attached to a delivery wire - · set of GDC connecting cables - · patient return electrode - two 9-volt batteries The GDC is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. GDC coils are manufactured from a platinum / tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, the coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC). GDC coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K991139. GDC coils are available in a range of sizes for use with either Boston Scientific Target's -10 or -18 Infusion Catheters with two tip markers. The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm. Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting. The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by: - 1) sensing the amount of resistance to current flow through the GDC System, and - 2) adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment. Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.

The In-Time™ Retrieval Device is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

The In-Time™ Retrieval Device consists of a braided catheter shaft, with a radiopaque basket attached to the distal tip of the catheter. The inner lumen of the catheter contains a flexible, guiding corewire, which is tapered from the proximal to distal end. The corewire extends distally 3 cm from the basket and is not removable from the catheter. The corewire can be rotated freely as well as moved distally and proximally within the catheter approximately 1.5 cm. The 3 cm radiopaque distal coil extending from the basket facilitates fluoroscopic visualization. A luer fitting is located on the catheter hub and is used for the attachment of accessories and to facilitate the continuous flush of solution. The catheter shaft is coated with HYDROLENE™, a hydrophilic coating that reduces friction during manipulation in a guide catheter and in blood vessels. The In-Time™ Retrieval Device is designed to be used with a guide catheter. The In-Time™ Retrieval Device can be used in vessel diameters ranging from 2 mm to 4 mm.

The Matrix™ Detachable Coils have the same indications for use as the predicate GDC" coils. Matrix™ Detachable 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, and for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

The Matrix™ Detachable Coil system consists of the following, each of which is sold seperately: - · GDCTM SynerGTM Power Supply - · Matrix™ Detachable Coil attached to a delivery wire - · Set of GDCTM SynerGTM connecting cables - Patient return electrode - · Two 9-volt batteries The coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. Matrix™ Detachable Coils are manufactured from platinum wire, which is first wound into a primary coil and then formed into a secondary helical shape. Coating the platinum coil is a proprietary biocompatible absorbable polymer mixture. Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is identical to that employed for the predicate GDCTM Coils cleared under K001083. The GDCTM SynerGTM power supply is a battery-operated, selfcontained unit designed to initiate and control the electrolytic detachment of a GDC™ Coil or Matrix™ Detachable Coil inside an aneurysm. The GDC™ SynerG™ Power Supply is designed to apply a constant current through the GDC™ System and to detect when coil detachment has occurred. It maintains a constant current by: 1) sensing the amount of resistance to current flow through the Matrix™ Detachable Coil, and 2) adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the Matrix™ Detachable Coil and to recognize those changes, which indicate detachment. Once those patterns are identified, the GDCTM SynerGTM power supply signals detachment and stops the flow of current through the Matrix™ Detachable Coil.

The Excelsior SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

The Excelsior SL-10 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and guidewire. The device shaft is comprised of graded materials of varying durometers, from a flexible tip to a semirigid proximal end. Stainless steel wire reinforcement provides for strength during torque transmission while the inner liner provides for lubricity. The hub / strain reliefs provide for kink resistance from the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The radiopaque tip with one or two markers allows for visualization under fluoroscopy. The outer surface is coated with a hydrophilic coating which reduces friction during navigation in the vasculature. A steam shaping mandrel accessory is packaged with the catheter.