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The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

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The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows: Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.

The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.

The Cordis Neurovascular, Inc. HYPERTRANSIT™ Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.

The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils.

The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing certain intracranial ancurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be: very high-risk for management by traditional operative techniques l ) inoperable 2) and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulac of the neurovasculature. The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

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The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.

The Cordis Neurovascular, Inc. HYPERTRANSIT Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.

The TRUFILL® DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be: 1) very high-risk for management by traditional operative techniques 2) inoperable and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

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The TRUFILL DCS ORBIT™ Detachable Coil is intended for embolizing certain 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: very high risk for management by traditional operative techniques, or, 1. inoperable, 2. and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

The TRUFILL DCS ORBIT™ Detachable Coil System is comprised of the TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe. - The TRUFILL DCS ORBIT™ Detachable Coil consists of a delivery system . (delivery tube and coil introducer) and an embolic coil. The delivery tube segment comprises the body of the device and has the combined functionality of a guidewire and a mini infusion catheter. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the infusion catheter. The embolic coil is the implantable segment of the device. - The TRUFILL® DCS Syringe is used to generate a controlled pressure for . preparation and detachment of the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube. The gauge faceplate is calibrated for three settings for use with the TRUFILL® family of Detachable Coils.

The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .018" and smaller for PROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10 and 14, depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.