XVIVO Lung Cannula Set™ Leaflet
Single-use, sterile disposable product
XVIVO Lung Cannula Set™ is a sterile, single-use set to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment. The cannulas are made of PVC and medical-grade TPE, both of which are FDA Class VI biocompatible, DEHP and latex-free.
Built-in pressure lines facilitate reliable readings to avoid any hydrostatic pressure to the lungs. The luer lock connections enable easy connection to monitoring equipment.
PVC and medical-grade TPE material selected for safety and easy handling. The material gives stability yet is soft enough for running sutures.
The XVIVO Lung Cannula Set™ is designed to work with the XVIVO Organ Chamber™. Cannula positions should be checked and especially a gentle traction on the LA cannula is applied to assure good patency of pulmonary veins.
The cannula set contains three color-coded cannulas in sterile packaging. Straight cannula with yellow cap to be used for the pulmonary artery (PA), cone cannula with green cap to be used for the left atrial (LA) cuff and a cone cannula with white luer-capped end to be used as a back-up cannula either to the pulmonary atrium or atrial cuff.
Straight cannula with yellow cap to be used for the pulmonary artery.
Cone cannula with green luer-capped end to be used for the left atrial cuff.
Cone cannula with white luer-capped end to be used as a back-up cannula either to the pulmonary artery or left atrial cuff.
Several descriptions of clinical usage of the cannula are available in the literature1,2,3. The directions for use is only provided as a suggested procedure. The user must on the basis of her or his medical training and experience evaluate the suitability of this procedure.
The LA appendage is trimmed off and the specially designed funnel-shaped cannula with built-in pressure line is sutured to the inside of the LA cuff with a 4-0 monofilament suture to create a closed circuit. The cannula splints the LA open to create a reliable and consistent outflow drainage. Connect the pressure line to sensor via green-capped luer end.
The straight cannula is placed into the pulmonary artery up to the point of bifurcation and tied into place with umbilical tape tied across the pulmonary artery around the cannula´s grooved radius. When enough cuff for PA is available the cannula is secured with 0 silk ties, or if the cuff is too short the same funnel-shaped cannula used for LA (green capped) cannulation can be used.
The PVC and medical-grade TPE material was selected to facilitate trimming of funnel to fit either left atrial cuff radius or the pulmonary artery.
If cuffs are too short, additional donor tissue such as aorta, pericardium, or vena cava can be used to construct neo-cuffs4.
To order: REF 19022; 1 set (1 x 3 pcs)
Content: 1 XVIVO Lung Cannula Set™ – straight cannula (yellow cap), cone cannula (green cap) and cone cannula (white cap)
Packaging: Sterile Chevron pouch.
Storage: Store at room temperature. Use only unopened and undamaged packages.
Shelf life: At least three months from date of shipment.
Intended Use: The XVIVO Lung Cannula Set™ is a sterile single use device intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex vivo assessment.
Properties: Sterility assurance level 10-6
Bacterial Endotoxins (LAL assay) EU/device <20
*In the US, the XPS™ with STEEN™ Solution is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for transplantation.