Australia - English - Department of Health (Therapeutic Goods Administration)

life systems medical pty ltd - 45452 - cardiac tissue ablation system - the easac system is intended to be used to direct light energy in the antrum of the pulmonary veins to create conduction block as a treatment for atrial fibrillation in patients aged 18 or older. the easac system consists of the easac catheter, and the easac laser ablation console. the easac console assists in compliant balloon adjustment, endoscopic image management using the light track software, the selection of energy delivery parameters and the issuance of a final procedure report.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 36035 - prosthesis, internal, stent, vascular - the carotid wallstent consists of a metal stent pre-mounted on the inner shaft of a monorail delivery system covered by an outer sheath. a guiding catheter with wire is inserted percutaneously & tracked through the vasculature. the device is then back-loaded over the guidewire & positioned at the site of the stenosis with the aid of 2 radiopaque markers. the stent is deployed by sliding back the t connector & pulling back the outer sheath, allowing the stent to expand & appose the vessel walls. treatment of stenoses of the common carotid artery (cca), internal carotid artery (ica) and carotid bifurcation.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 17541 - catheter balloon inflation system, single-use - indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 35094 - catheter guide wire - the guide wire facilitates placement of a catheter during diagnostic or interventional procedures.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 35094 - catheter guide wire - this steerable guidewire family is intended for general intravascular use in the peripheral vasculature. it can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 45623 - non-vascular guidewire - used in the selective cannulation of the biliary ducts and to aid in the placement of diagnostic and therapeutic devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 45623 - non-vascular guidewire - used to facilitate the placement of endourological instruments during diagnostic or interventional procedures

Australia - English - Department of Health (Therapeutic Goods Administration)

life systems medical pty ltd - 36079 - catheter introducer, haemostasis valve - the cardiofocus deflectable sheath is intended for use when introducing and navigating the cardiofocus endoscopic ablation system in the left atrium.

Australia - English - Department of Health (Therapeutic Goods Administration)

medline international two australia pty ltd - 10678 - catheter introducing sheath - the guidewire introducer is used to facilitate the introduction of a guidewire which is used in intravascular procedures to feed a catheter over the top. it indirectly facilities the introduction of a catheter into the patient's vein or artery.

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 45608 - catheter slitter - universal cutter is a handheld device intended to facilitate guide catheter removal after the boston scientific or guidant coronary venous lead is positioned.