PFCL ARCALINE and ARCOTANE are perioperative liquids used to help the surgeon in the treatment of retinal tears.
Their purity and chemical stability reduce possible interactions with the different intraocular tissues. Elimination of C-H groups and fluorides is particularly important.
- Arcaline perfluorodecalin is guaranteed to 97% purity
- Arcotane perfluorooctane is guaranteed to 99% purity
With superior guaranty
AÂ final validation of the non-toxicity using biological tests.
All products release is depending on the certification of their non-toxicity on Human ARPE retinal cellsÂ and Porcine retinal explants carried out by IOBA Institute * following their protocol.
*ACUTE RETINAL DAMAGE AFTER USING A TOXIC PERFLUORO-OCTANE FOR VITREO-RETINAL SURGERY-<RETINA 37: 1140-1151, 2017
Multi-use tool for vitreoretinal surgery
PFCLs are perioperative liquids used to help surgeons to peel membranes, remove sub-retinal liquids, reapply the retina and fix it for endophotocoagulation.
For more than fifteen years, Arcaline perfluorodecalin has been my first choice of PFCL. Its low viscosity enables an easy injection and aspiration even when using vitrectomy instruments with a small diameter. Its high density makes it an essential tool in the treatment of complex retinal detachments and some retinal detachments with posterior dehiscence. It has always been perfectly tolerated and has become a faithful ally in the fight against retinal detachments.
Arcotane perfluorooctane is a choice tool in complex vitreoretinal surgery, particularly in the treatment of retinal detachment.
Better visualisation of the interface as well as its easier removal are its dominant properties. This significantly facilitates tamponade / air exchange.
Perioperative instruments for retinal surgery, in particular in the case of giant tears, retinal detachment, vitreoretinal proliferation, including proliferative diabetic retinopathies, drainage of sub-retinal liquids, recovery of foreign bodies, natural or artificial crystalline lens dislocated in the vitreous body, stopping bleeding, stabilisation of the membranes, etc…
Instruction for use
ARCALINE/ARCOTANE – INSTRUCTIONS FOR USE
ARCALINE: Perfluorodecalin aid for retinal surgery
ARCOTANE: Perfluorooctane aid for retinal surgery
ARCALINE: Purified perfluorodecalin, sterile and apyrogenic
ARCOTANE: Purified perfluorooctane, sterile and apyrogenic
ARCALINE/ARCOTANE are presented in a glass vial sealed with a polymer stopper and a metal crimp cap. A pouchÂ bag guarantees the external sterility; the product is presented with single use 20G needle and syringe (10ml).
Three volumes are available for ARCALINE (5ml; 7ml), two volumes for ARCOTANE (5ml; 7ml) depending on theÂ surgical procedure. This product contains neither latex nor phtalates.
Per-operative devices for retinal surgery; in particular, retinal detachment (RD), RD with giant tear, RD withÂ proliferative vitreal retinopathy (PVR) including diabetic proliferative retinopathy, flushing out of the subretinalÂ liquids, retrieval of foreign bodies, luxated crystalline lens or artificial lens in the vitreous.
ARCALINE/ARCOTANE should not be allowed to infiltrate into the sub-retinal space since there are no specificÂ studies on tolerance. Retina too fibrotic to enable reattachment. Posterior dehiscence.
Sub-retinal passage, scotoma, especially if present in foveal area. Corneal toxicity. Cataract. Emulsification,Â retinal deposits of the residuals in presence of silicone oil.
Side effects linked to retinal surgery
Transitory hypotony during the exchange of PFCL with the tamponade productÂ Dehiscence, enlargement of the tear during the peeling maneuver.
In very rare cases, unexplained visual loss including â€śmacula onâ€ť retinal surgery.
ARCALINE and ARCOTANE are per-operative devices for vitreo-retinal surgery. They are exclusively intended toÂ be used by ophthalmologists trained to this technique.
The volume to inject should be adapted to the procedure.
ARCALINE and ARCOTANE are designed to be removed at the end of the procedure; patients should be informedÂ of possible residual droplets and their eventual side effects that they should bring to the caretakerâ€™s attention.
It is strongly recommended to use the accessories provided in the packaging. It is strongly recommended notÂ to use a glass syringe.
Compatibility with MRI imaging: ARCALINE and ARCOTANE are perfluorinated compounds and are characterizedÂ by the lack of hydrogen. PFCL do not contain any hydrogen atoms and therefore do not give any signal.
PFCL significantly decrease ultrasound speed.
Single use only. The sterility and purity of ARCALINE and ARCOTANE are only guaranteed for a single use. Do notÂ re-sterilize. Do not use after the expiration date. Do not use the needle for intra-ocular injection. Do not use ifÂ the sterility protecting packaging is damaged.
Instructions for use
Fit the needle onto the syringe, remove the plastic part of the metal cap of the vial and pierce the stopper.
Transfer ARCALINE/ARCOTANE from the vial into the syringe. Replace the needle with a blunt cannula for intravitreousÂ injection.
Giant tear, retinal detachment (RD)
Inject ARCALINE/ARCOTANE slowly and progressively, just in front of the tear, after total pars plana vitrectomy.
Maintain the tip of the cannula inside of the bubble during the injection to prevent the product dispersion. IfÂ despite this precaution, dispersion occurs, the droplets will spontaneously regroup into the principal ARCALINE/ARCOTANE bubble, or can be removed thanks to an extrusion cannula. Thanks to their high density ARCALINE/ARCOTANE reattach the retinal flap from the posterior pole towards the periphery, flushing ahead the subretinalÂ liquid, the removal of which is then passively performed through the sclerotomy incisions.
The progressive retina re-attachment should be controlled to avoid sub-retinal passage: any residual tractionÂ should be cancelled in order to get a soft re-attachable retina. Always keep ARCALINE/ARCOTANE in front of theÂ edge of the tear to prevent sub-retinal passage.
RD with vitreo-retinal proliferation (PVR)
After vitrectomy, proceed with the dissection of the posterior epiretinal membranes. Then, inject ARCALINE/ARCOTANE slowly and gradually, restrain to completely fill the vitreous cavity. The posterior retina is stabilizedÂ and allows the treatment of the anterior epiretinal membranes. Always proceed ahead of the bubble to avoidÂ the sub-retinal passage in case of iatrogenic tear occurrence.
In the case of tight retinal funnel, with strong anterior pull, open the funnel with an injection of a small volumeÂ of ARCALINE/ARCOTANE: the surface of the retina is stabilized and enables the anterior epiretinal membranesÂ dissection.
Then, after removal of the product, proceed with the posterior membranes dissection. When the retina isÂ completely released, a second injection to totally fill the cavity enables the re-attachment and the sub-retinalÂ fluids drainage as in the giant tear case.
Retinopexy using endophotocoagulation can be performed
The contact of the product with the retina should be limited as much as possible. It should not be left in placeÂ in the eye at the end of the procedure. The total quantity injected shall be removed at the end of the surgery.
The removal is carried out, either passively through the downwards fluid, air, perfluorinated gas or siliconeÂ oil injection: ARCALINE/ARCOTANE is thus pushed downwards and passively removed through an extrusionÂ cannula, or by aspiration.
A meniscus may occur at the end of the ARCALINE/ARCOTANE-air or perfluorinated gas exchange: the reinjectionÂ of a small volume of Ringer or BSS disperses the residual quantity and enables the complete removal.
ARCALINE/ARCOTANE-air or perfluorinated gas exchange duration should not be extended; high intraocularÂ pressure should be maintained during the exchange.
The risk of sub-retinal passage is increased in the case of wide peripheral retinotomy, especially when it reachesÂ 360 degrees. Rinsing with a saline solution during the exchange seems to be useful to reduce the sub-retinalÂ passage.
Foreign bodies and subluxated natural crystalline or artificial lens can be removed thanks to ARCALINE/
ARCOTANE once they are completely released from surrounding vitreous after performing a complete pars planaÂ vitrectomy. The ARCALINE/ARCOTANE is directly injected underneath the material to be removed, which then will float on ARCALINE/ARCOTANE surface and can then be safely extracted.
Strictly reserved for surgeons trained in retinal surgery.
No particular storage requirement. Store at room temperature and in a dry place.
Waste disposal :
With household waste or recycle With hospital waste
Paper box, Instructions For Use leaflet,Â traceability labels, peelable pouches Needle
Syringe and glass vial
Sterilizing filtration and autoclave.
ARCALINE 1.31 141Â°C 13.5mmHg/37Â°C 1.94
ARCOTANE 1.27 102Â°C 57mmHg/37Â°C 1.76
CE marked from May 6, 2002
Arcadophta – CE0459 (Arcaline/Arcotane vial) – 11 rue Antoine Ricord – 31100 Toulouse – France
Tel.: 33(0)5 61 40 52 35. Fax: 33(0)5 61 40 84 66 – E-mail: email@example.com
Henke-Sass, Wolf GmbH – C0086 (accessories syringe/needle)
KeltenstraĂźe 1, 78532 Tuttlingen – Germany