澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 60910 - coronary venous pacing lead - implantable, steroid eluting, quadripolar, coronary sinus lead, is4 connector. the lead body consists of a coil made up of several parallel wires. the insulation is composed of silicone and is covered by a polyurethane tube which improves gliding properties. atraumatic fixation with a silicone thread between the tip electrode and the ring electrode, which wedges itself directly between the vessel walls. suitable for coronary vessels with small internal diameters. mr conditional. in combination with a compatible implantable triple-chamber pacemaker or icd,this lead is indicated for the following: ? permanent, transvenous implantation in the coronary venous system via the coronary sinus of the left side of the heart ? permanent sensing and pacing of the left ventricle

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

bio-excel australia pty ltd - 56285 - drug-eluting coronary artery stent, carbon-coated - the cre8 evo device consists of a sirolimus eluting coronary stent firmly held on the distal end of semi-compliant balloon catheter. two radio-opaque platinum markers at either end of the stent enable accurate positioning on the lesion to be treated. the rapid-exchange type balloon catheter provides a safe means for delivering the coronary stent to the lesion to be treated. the coronary stent is indicated for the treatment of stenotic lesions in coronary arteries and coronary artery bypasses to maintain vessel patency. this device is mr conditional.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

bio-excel australia pty ltd - 56285 - drug-eluting coronary artery stent, carbon-coated - the cre8 evo device consists of a sirolimus eluting coronary stent firmly held on the distal end of a semi -compliant balloon. two radio-opaque platinum markers at either end of the stent enable accurate positioning on the lesion to be treated. the rapid exchange type balloon catheter provides a safe means for delivering the coronary stent to the lesion to be treated. the coronary stent is indicated for the treatment of stenotic lesions in coronary arteries and coronary artery bypasses to maintain vessel patency. this device is mr conditional.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

bio-excel australia pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - raiden 3 is a rapid exchange percutaneous transluminal coronary angioplasty balloon dilatation catheter. the distal side of the catheter is equipped with a balloon inflation to a specific diameter and length at recommended pressures. radiopaque marker (s) allows for confirmation of balloon's position in patient vessel under high resolution fluoroscopy. the inner lumen of the catheter is used to facilitate passage of 0.014" guide-wire and the other lumen for inflation/deflation of the balloon. this product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (ptca).

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

bio-excel australia pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - ikazuchi zero is a rapid exchange percutaneous transluminal coronary angioplasty balloon dilatation catheter. the distal side of the catheter is equipped with a balloon inflatable to a specific diameter and length at recommended pressures. radiopague marker(s) allows for confirmation of balloon's position in the patient vessel under high resolution fluoroscopy. the inner lumen is used to facilitate passage of a 0.014" guide wire while the other lumen is used for inflation/deflation of balloon. this product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (ptca).

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

orbusneich medical pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - sapphire ii nc coronary dilatation catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. ?1.75 mm to 4.0 mm balloons have a rated burst pressure of 20 atmospheres and ?4.5 mm to 5.0 mm balloons have a rated burst pressure of 18 atmospheres.the guidewire enters the catheter tip and advances coaxially out the distal rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. sapphire ii nc is indicated for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 62218 - coronary angioplasty balloon catheter, drug-eluting - the agent monorail ptca balloon catheter has a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient that is designed to inhibit restenosis by delivering drug to diseased arterial tissue. the outer lumen is used for inflation of the balloon, and the inner lumen permits the use of guidewires to facilitate advancement of the catheter. the balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. the agent balloon catheter is indicated for percutaneous transluminal coronary angioplasty (ptca) in the coronary arteries to treat in-stent restenosis (isr) and de novo / small vessel disease.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

orbusneich medical pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - scoreflex nc is a scoring balloon catheter designed for easy guidewire exchange. the lumen tip section of the catheter is compatible with a 0.014 inch guidewire. the guide wire enters the catheter tip and advances coaxially out the tip rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. when the balloon inflates it expands the lesion and generates focal forces at the location of the wires external to the balloon. scoreflex nc is indicated for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

orbusneich medical pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - sapphire ii pro coronary dilatation catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. 1.0mm to 1.5mm balloons have a rated burst pressure of 16 atmospheres and 1.75mm to 4.0mm balloons have a rated burst pressure of 14 atmospheres. the guidewire enters the catheter tip and advances coaxially out the distal rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. sapphire ii pro is indicated for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 61205 - mechanical atherectomy system, coronary, line-powered - the device (oad) is a hand-held, over the wire device that includes a sheath covered drive shaft and a diamond coated crown. the diamond coating on the crown provides an abrasive surface with which to reduce coronary plaque within coronary arteries. the oad is designed to track and spin only over the csi viperwire advance coronary guide wire. the glideassist feature allows users to spin the oad at a slow rotational speed (5,000 rpm) to reduce friction during insertion and removal of the crown. the diamondback 360 coronary orbital atherectomy device classic (oad)is a component of the diamondback 360 coronary orbital atherectomy system (oas), a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (cad) who are acceptable candidates for ptca or stenting due to de novo, severely calcified coronary artery lesions. oad consists of the diamond-coated crown, drive shaft, saline shealth, physician-operated handle, power supply cable that connects to the oas pump and saline port connector for the saline line.