Search Results

The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.

The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.

The Detachable Silicone Balloon (DSB) is intended for artificial embolization of the internal carotid artery in the presence of certain intracranial aneurysms in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.

The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.

The Retriever II is indicated for use in the retrieval of intravascular occlusion coils misplaced during interventional radiological procedures in peripheral and neurovasculature.

The Retriever II (R-II) is a single use, disposable endovascular Snare. The R-II consists of a flexible core wire, radiopaque coils at the distal end of the corewire facilitate fluoroscopic visualization. Fiber strands are attached to the distal tip of the core wire. A platinum tip marker is attached at the distal end of the fibers to facilitate fluoroscopic visualization. The fibers, when manipulated, work to ensnare the misplaced coil.

See table below | Device Name | Indications | |--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Guglielmi Detachable Coils (GDC®) | For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the<br>patient's general medical condition - are considered by the treating neurosurgical team to be a) very high<br>risk for management by traditional operative techniques, or b) inoperable; and for embolizing other<br>vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro<br>vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral<br>vasculature. | | Occlusion Coils: | | | Fibered Platinum Coil, .035" Type | For arterial and venous embolizations in the peripheral vasculature | | Berenstein Liquid Coil | For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature. | | Occlusion Coils (except Fibered<br>Platinum Coil .035" Type and<br>Berenstein Liquid Coil) | Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are<br>intended for use in the interventional radiologic management of arteriovenous malformations and<br>arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable. | | Guidewires | Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion<br>Catheters to selected vascular sites. | | Tracker® Infusion Catheter | Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast<br>media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and<br>neurovasculature. | | Stealth® Dilation Catheter | The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This<br>device is not intended for use in the coronary arteries. | | Coil Pusher | The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque gold<br>marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site. | | Guidewire Introducer | The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs<br>or hemostatic valves. | | Guidewire Torquer | The guidewire torquer was developed to enhance control of torqueable guidewires during intravascular<br>placement. | | Rotating Hemostatic Valve | To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the<br>placement of a therapeutic or diagnostic catheter. | | Shaping Mandrel | The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a<br>catheter tip to suit the requirements of a particular case. | | Valve Wire | The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the<br>balloon section enabling it to be inflated. |

Please refer to Table 1 (Page 10)

The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.

Spinnaker Infusion Catheter is a single lumen device with a graded shaft stiffness, ranging from a highly flexible tip to a semi-rigid proximal section that allows ease of advancement by the physician. A lure fitting located on the catherer hub is used for the attachment of accessories. Spinnaker is manufactured with HYDROLENE®, a hydrophilic surface coating that reduces friction during manipulation in the vessel. The Spinnaker Infusion Catheter will be made available as a system consisting of a Spinnaker Infusion Catheter, a stylet with a torque device attached, and a steam shaping mandrel. SPINNAKER with HYDROLENE Infusion Catheter (SPINNAKER) is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section allows ease of advancement by the physician. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip and body facilitate fluoroscopic visualization. SPINNAKER is manufactured with HYDROLENE, a hydrophilic surface that reduces friction during manipulation in the vessel. The stylet accompanying the SPINNAKER is used to increase rigidity of the distal section during introduction into the guiding catheter. The steam shaping mandrel packaged with the SPINNAKER is used when the physician desires to shape the catheter's distal end.

Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.

The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque. The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter. An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separately.

The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.

Target Therapeutics' Patient Return Electrode (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient's upper arm (deltoid). The PRE is being made available for patient comfort and has no effect on the safety or efficacy of the GDC system as functional testing indicates. A small Prep pad is included with the PRE to exfoliate the skin prior to applying the PRE.

The Guglielmi Detachable Coil (GDC) 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: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.

Berenstein Coils are intended for the embolization of vascular malformations of the neuro vasculature.

The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque. The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter. An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separatelv.

The Guglielmi Detachable Coil (GDC) 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: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovencus fistulae of the neuro vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.