Portico™ Transfemoral/Alternative Access Loading System ("Loading System"); Indications; Contraindications - St.Jude Medical PRT-23 Mode D'emploi

The distal end of the delivery system includes the following features (Figure 2):
• An atraumatic radiopaque tip - Used to guide the delivery system and facilitate visualization.
• A protective sheath - Covers and maintains the valve in the collapsed position. The protective sheath features a protective sheath marker
band that provides a reference point used to determine the extent of the valve deployment. The protective sheath may be advanced or retracted
to facilitate valve loading and deployment. When the protective sheath is retracted the inner shaft is exposed.
• An inner shaft – The valve is loaded onto the inner shaft. Retainer tabs on the valve lock into a retainer receptacle that is mounted on the
inner shaft. The inner shaft also features a radiopaque inner shaft marker band that provides a reference point used to align the valve in the
native annulus.
protective
sheath
retainer receptacle
inner shaft
protective sheath
marker band
Figure 2: Distal end of the delivery system
A handle is located on the proximal end of the delivery system. The handle includes the following features (Figure 3):
(1) Two sliding mechanism buttons - Facilitate rapid travel of the protective sheath. The sliding mechanism is used to open the delivery system
for valve loading and may be used to re-sheath the delivery system prior to withdrawal from the descending aorta.
(2) A deployment/re-sheath wheel - Used to adjust the position of the protective sheath during valve loading and deployment.
(3) Two locking buttons - Control movement of the sliding mechanism.
(4) A release lever - Used to prevent full valve deployment before valve position is optimized.
(5) A sheath flush port - Facilitates de-airing of the delivery system sheath.
(6) A lumen flush port - Facilitates de-airing of the delivery system lumen.
3
2
6
4
3
Figure 3: Delivery system handle
Portico™ Transfemoral/alternative access Loading System ("Loading System")
The Portico™ transfemoral/alternative access loading system facilitates valve preparation/loading onto the Portico™ transfemoral delivery system.
The loading system includes a loading funnel, loading base, base insert, loading tube, and two leaflet testers (Figure 4).
loading
loading base
funnel
Figure 4: Loading system

INDICaTIONS

The Portico™ valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are considered high surgical
risk.
The Portico™ transfemoral delivery system is indicated for transfemoral delivery of the Portico™ valve.
The Portico™ transfemoral/alternative access loading system is indicated for loading the Portico™ valve in the Portico™ transfemoral delivery
system.

CONTRaINDICaTIONS

The valve is contraindicated for patients with:
• Any sepsis, including active endocarditis.
• Any evidence of left ventricular or atrial thrombus.
• Vascular conditions (i.e., stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve impossible.
• Non-calcified aortic annulus.
radiopaque tip
inner shaft
marker band
1
5
1
base insert
loading tube
leaflet testers
3