Section 1 Instructions For Use; Components And Description - Vascutek Thoraflex THP2224X100B Instrucciones De Uso

SECTION 1 INSTRUCTIONS FOR USE

This booklet provides instructions for the use of the Thoraflex™ Hybrid System.
SECTION 1.1 COMPONENTS AND DESCRIPTION
The Vascutek Ltd. Thoraflex™ Hybrid System consists of the Thoraflex™ Hybrid Device contained within
a delivery system as shown in Figure 1. The Thoraflex™ Hybrid Device is made from gelatin sealed woven
polyester, a section of which has the addition of nitinol ring stents as shown in Figures 2 and 3. The device is
specifically designed to repair or replace damaged or diseased vessels of the aortic arch and descending aorta
with or without involvement of the ascending aorta in cases of aneurysm and/or dissection by open surgical repair.
The branches of the Plexus 4 version (Figure 2) are provided to accommodate reconstruction of the major aortic
branch vessels and the intra-operative attachment of a perfusion cannula during cardio-pulmonary bypass where
antegrade perfusion techniques are used. The stented section of the device enables treatment of the diseased
descending thoracic aorta without the need to anastomose a stented and unstented device together.
The Thoraflex™ Hybrid Device has been impregnated with an absorbable protein. The aim of the impregnation is
to provide a polyester vascular device that does not require pre-clotting. The protein is a bovine gelatin which has
been cross-linked to a set level in order to control its rate of removal. It serves in place of fibrin, which seals the
polyester device during normal pre-clotting. The gelatin is hydrolysed within 30 days and is replaced by normal
tissue incorporation. Gelatin was chosen as it is a non-toxic protein, a fact which is reflected by its extensive use
as a safe plasma expander.
Thoraflex™ Hybrid Device
Plexus 4 graft section
Red release
clip
Handle
Figure 1 – Thoraflex™ Hybrid Delivery System (Plexus 4 Version)
Splitter
Strap
Splittable
sheath
Thoraflex™ Hybrid Device
stented section inside the sheath
Malleable shaft
Collar
position
Tip
5