Instructions For Use - Vascutek Thoraflex Hybrid Instrucciones De Uso

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Description

The Vascutek Thoraflex Hybrid™ Device is a woven polyester prosthesis, with the addition of nitinol ring stents

as shown in Figure 1. The device is specifically designed for the treatment of aneurysm and/or dissection in the

ascending thoracic aorta, aortic arch and descending thoracic aorta. Branches are provided to accommodate

reconstruction of the major aortic branch vessels and intra-operative attachment of a perfusion cannula during

cardio-pulmonary bypass where antegrade perfusion techniques are employed. The stented section of the graft

enables treatment of the diseased descending thoracic aorta in a single-stage procedure without the need to

anastamose a stented and unstented prostheses together.

The Vascutek Thoraflex Hybrid™ device has been impregnated with an absorbable protein. The aim of the

impregnation is to provide a polyester vascular prosthesis which does not require pre-clotting. The protein is a

bovine gelatin which has been cross-linked to a set level to control its rate of removal. It serves in place of fibrin,

which seals the polyester prosthesis during normal pre-clotting. The gelatin is hydrolyzed within approximately 14

days and is replaced by normal tissue incorporation. Gelatin has been chosen as it is a non-toxic protein, a fact

which is reflected by its extensive use as a safe plasma expander.

Figure 1 – Thoraflex Hybrid™ Device

Gelatin sealed,

Plexus* 4

prosthesis

Perfusion

Side Branch

*Gelweave graft material

Figure 2 – Thoraflex Hybrid™ System

Splittable

PTFE Sheath

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