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Adverse events should be reported. For UK: Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Santen UK Limited (email: medinfo@santen.co.uk or telephone: 0345 075 4863). For Ireland: Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Santen UK Limited (email: medinfo@santen.co.uk or telephone: +353 1 695 0008).

PRESERFLO

What do you expect from glaucoma surgery?

PRESERFLO™ MicroShunt is a state-of-the-art device, developed through a collaboration between surgeons and ophthalmologists.1,2  It is intended for reduction of intraocular pressure (IOP) in eyes of patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.3

PRESERFLO™ MicroShunt uses a subconjunctival surgical route to efficiently drain aqueous humour3

  • PRESERFLO™ MicroShunt drains aqueous humour from the anterior chamber to a fornix-based subconjunctival/ Tenon’s flap1,2
  • This drainage bypasses the conventional pathways such as the trabecular network, Schlemm’s canal, collector channels and the scleral venous plexus2-6

PRESERFLO™ MicroShunt: innovative design to control IOP1,2

  • PRESERFLO™ MicroShunt uses the unique SIBS material that offers several advantages for ocular surgery1-3,8-14

    SIBS: poly(styrene-block-isobutylene-block-styrene)

  • Training process and recommendations

    In order to ensure the best outcomes for your patients with PRESERFLO™ MicroShunt, it is important to adhere to a methodical training process:

    You can facilitate the training process by:

    • viewing the implantation steps and video before training
    • selecting the optimum patient to facilitate training:

    INCLUSION CRITERIA

    • Early to severe POAG
    • Pre-op IOP over 18 mmHg, with uncontrolled IOP on maximum tolerated medication
    • A free-moving conjunctiva in the area of implantation (preferably in superior temporal quadrant)

     

    EXCLUSION CRITERIA

    • Poor conjunctival quality at the PRESERFLO™ MicroShunt insertion quadrant:
      • Conjunctival inflammation
      • Previous incisional ophthalmic surgery involving the conjunctiva in the area of entry into the anterior chamber
      • Eyes subject to topical medication for extended periods of time
    • Neovascularisation, uveitic glaucoma or active uveitis
    • Choroidopathy/ choroidal detachment
    • Severe blepharitis
  • Securing funds to purchase PRESERFLO™ MicroShunt in the NHS

    The process for adopting medical devices at a hospital level is initially dependent upon the clinician requesting the medical device through completion of documentation (business case) in order to gain approval for use of this device from hospital management committees.

    Some of the key components of a business case include:

    • Clinical benefits of new technology versus existing procedures
    • Financial analysis and available funding flows
    • Alignment with hospital strategy
    • Risk Strategy
    • Patient care requirements

    A business case support dossier and budget impact/ cost analysis tool has been developed to support clinicians to complete business case documentation.

WHERE NEXT?

PRESERFLO™ instructions for use

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