Singapore - English - HSA (Health Sciences Authority)

somnotec (s) pte. ltd. - cardiovascular - the occlutech® pda occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of patent ductus arteriosus (pda).

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

life systems medical pty ltd - 45419 - cardiac occluder delivery kit - includes delivery sheath, y-hemostasis valve, dilator and loader. the dilator is inserted into the delivery sheath and both passed over a previously positioned guide wire into position through the vasculature. the dilator is removed and a separately supplied cardiac occluder and pusher are threaded into the combined y-hemostasis valve/loader which is then connected to the delivery sheath. after positioning and release of the occluder, the delivery system is withdrawn from the vascular system. the occlutech delivery set is intended for carrying out percutaneous, catheter-based interventions to deploy occlutech implants into the heart or the vasculature. with the aid of the occlutech delivery set, a compatible occlutech implant can be passed through the vascular system to its intended site of implantation.

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

life systems medical pty ltd - 44889 - catheter, intravascular, morphological measurement - the balloon contains three x-ray compatible marker bands which function as radiographic measurement reference. the balloon is introduced transcutaneously over a guidewire to the defect and inflated until either a slight constriction is identified or blood flow stopped. two different methods can be used to carry out a measurement with the sizing balloon: radiography or echocardiography. the occlutech sizing balloon is intended to assist determining the size of a cardiac septal defect. used in combination with radiographic or echocardiographic imaging, the occlutech sizing balloon is intended to aid in selecting an appropriate size for a cardiac implant for the closure of a septal defect. the occlutech sizing balloon is intended for venous access, used without a guide catheter and introduced directly via a guide wire.

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

life systems medical pty ltd - 45418 - cardiac occluder - the occluder and supplied pusher are connected by a threaded coupling and loaded via an appropriate loader into an introducing sheath, which has previously been positioned over a guidewire into the descending aorta. the pda occluder and connected pusher are advanced through to the tip of the introducing sheath and slowly released. once the position of the implant is confirmed by multiple angiograms, the introducing sheath is retracted so the shank of the implant unfolds inside the pda. the occlutech pda occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of patent ductus arteriosus (pda).

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

life systems medical pty ltd - 45418 - cardiac occluder - the occluder and supplied pusher are connected by a threaded coupling and loaded via an appropriate loader into an introducing sheath, which has previously been positioned over a guidewire into the descending aorta. the pda occluder and connected pusher are advanced through to the tip of the introducing sheath and slowly released. once the position of the implant is confirmed by multiple angiograms, the introducing sheath is retracted so the shank of the implant unfolds inside the pda. the occlutech pda occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of patent ductus arteriosus (pda).

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

occlutech australia - 45418 - cardiac occluder - the occluder and supplied pusher are loaded into an appropriate loader/introducer or occlutech delivery set, which has previously been positioned over a guidewire up to the right atrium of the heart, and pushed through to the tip of the introducer/delivery sheath. the left atrial (la) disc as well as the waist of the device is opened though careful further advance of the pusher and the implant pulled against the septum before slowly opening the right atrial (ra) disc until completely deployed. the figulla flex ii asd is an implant for closure of an asd ii (atrial septum defect of the secundum type) and is deployed via a minimally invasive catheter delivery system. the figulla flex ii asd is intended for patients with substantiated left-right-shunt and a clear indication for closure of the defect.

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

occlutech australia - 45418 - cardiac occluder - the occluder and supplied pusher are loaded into an appropriate loader/introducer or occlutech delivery set, which has previously been positioned over a guidewire up to the right atrium of the heart, and pushed through to the tip of the introducer/delivery sheath.the left atrial (la) disc as well as the waist of the device is opened though careful further advance of the pusher and the implant pulled against the septum before slowly opening the right atrial (ra) disc until completely deployed. the figulla flex ii pfo is an implant for closure of a patent foramen ovale (pfo). the implant is deployed via a minimally invasive catheter delivery system. the figulla flex ii pfo is intended for patients with substantiated right-left-shunt in the contrast agent echocardiography under valsalva maneuver and presence of a ?cryptogenic?, paradoxical thromboembolism.

Singapore - English - HSA (Health Sciences Authority)

somnotec (s) pte. ltd. - cardiovascular - the flex ii asd is a permanent cardiac implant intended to be delivered by a percutaneous, transcatheter procedure and to close atrial septal defects of type ostium secundum. the figulla flex ii asd occluder is a medical device intended for transcatheter closure of ostium secundum type asd. patients indicated for asd closure have: • echocardiographic evidence of ostium secundum- type asd • clinical evidence of right ventricular (rv) volume overload (hemodynamically significant left-to-right shunt with qp / qs ≥ 1.5 or rv enlargement)

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

life systems medical pty ltd - 17846 - catheter, intravascular, guiding - the delivery set consists of a braided sheath with a side port with a three-way stopcock, hemostatic valve, dilator and loader. the distal tip of the sheath is radiopaque and contains side flush portholes. the dilator can be locked on to the hub of the sheath.contents of package: 1. delivery sheath, 2. dilator, 3. loader, 4. ifu the delivery set is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other placements.

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

life systems medical pty ltd - 45418 - cardiac occluder - the occluder is a percutaneous transcatheter closure device consisting of two nitinol wire mesh discs connected by a flexible waist. the design allows the device to be pulled into a delivery sheath and reshaped once it is released. when correctly positioned and firmly attached on both sides of the septum, it conforms to the septal wall and closes a present atrial septal defect (asd). it is deployed using the included pusher via a minimally invasive catheter delivery system. a system including an occluder (figulla flex ii asd) and a pusher (flex pusher-ii). the occluder is an implant for closure of an asd ii (atrial septum defect of the secundum type) and is deployed using the pusher via a minimally invasive catheter delivery system. the system is intended for patients with substantiated left-right-shunt and a clear indication for closure of the defect.