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    TearScienceTM LipiFlowTM Thermal Pulsation System

    TearScienceTM LipiFlowTM Thermal Pulsation System

    LipiFlow® Thermal Pulsation System

    Instructional Guides

    Instructional Guides

    Instructional Guides

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    Designed to Improve Gland Function

    The TearScienceTM LipiFlowTM Thermal Pulsation System, is a medical device used by physicians in addressing Meibomian Gland Dysfunction (MGD). It consists of a Console and a single-use sterile device, known as the Activator, and has a drug-free mechanism of action. Eye care professionals use the TearScienceTM LipiFlowTM System to treat MGD patients in-office with confidence and efficiency.

    The TearScienceTM LipiFlowTM System represents more than 14 years of dedicated research and is protected by more than 30 patents. A phased pressure profile with adaptive force equalization and proximal-to-distal peristaltic motion evacuates gland contents as the inner lid is gently heated.

     

    How the TearScienceTM LipiFlowTM System Works

    • The procedure centers around the breakthrough Vectored Thermal Pulsation (VTP) Technology 
      After an initial anesthetic drop, no drugs are required for the procedure
      As the only automated treatment for MGD, TearScienceTM LipiFlowTM applies precise heat from the inner lid and pressure to remove gland obstructions while protecting delicate  structures of the eye2
      As a result, the obstructed meibum is liquefied and pushed up and out of the gland orifices
      Contoured design vaults the cornea and protects the eye
      Heat and pressure are regulated with redundant sensors

    •  

    Did You Know?

    • In one study, up to 86% of dry eye patients had signs of MGD3
      Approximately 1 in 5 patients with MGD are asymptomatic4
      TearScienceTM LipiFlowTM has been shown to increase gland secretion threefold, on average, with just one treatment2
      Safety and long-term effectiveness have been demonstrated in peer-reviewed studies5,6,7
      TearScienceTM LipiFlowTM installations are evenly divided between ophthalmology and optometry clinics
      TearScienceTM LipiFlowTM is available in more than 1500 practice locations in the United States and Canada as of January 2023

     

     

    The Science Behind TearScience® LipiFlow®

    Vectored Thermal Pulse (VTP) uniquely applies heat and peristaltic motion to the eyelid to remove gland obstructions and stagnant gland content.

    A vaulted design protects the cornea while multi-point sensors monitor and regulate heat and pressure throughout the treatment. This maximizes results and minimizes discomfort. Along with force equalization, the eye is protected from heat and pressure while a nominal therapeutic temperature of 42.5 degrees Celsius is applied directly to the inner eyelid where the glands are located, while protecting the eyelid or delicate structures of the globe.
     

    Proprietary heating technology ensures precise temperature regulation with continuous feedback and consistent heat application to the meibomian glands. The insulated and vaulted design of the Activator protects the cornea from unsafe temperatures.

     

    Intelligent pressure feedback loop sends pulsed sequences to expel blockages and stagnant material from the gland. The custom pressure sequence maximizes gland clearing while device design protects the eye from unnecessary intraocular pressure.

     

    The TearScienceTM Activator Clear

    Built for Efficiency 

    A translucent design for total confidence in the proper positioning of the Activator during placement.8

    Built with the Environment in Mind

    An innovative eye cup using a redesigned manufacturing process and fewer raw materials than its predecessor.8

    Built for Performance

    Precise, automated, bilateral application of heat and pressure across the entire lid every single time.8

    References

    1. M. A. Lemp, L. Bardfield, C.A. Blackie, H. P. Saras, S. Grenon, J Hutchinson, B Gravely,T. Douglass, D. R. Korb; Evaluation of a Novel Method of Treatment of Dry Eye. Invest.

    2. "Information based on internal competitive data and patent analysis as of June 2018 against TearScience and iLux Systems in the US. See iLux website http://www.tearfilm.com/ilux-device/ and TearCare website https://sightsciences.com/us/products/tear-care/reference 

    3. Lemp MA, et al. Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Patient Cohort. Cornea. 2012; 31(5): 472-478. doi:10.1097/ co.0b013e318225415a. 

    4. Viso E, et al. Prevalence of asymptomatic and symptomatic Meibomian Gland Dysfunction in the general population of Spain. Invest Ophthalmol Vis Sci. 2012; 53(6):  2601–2606. doi: 10.1167/ iovs.11-9228

    5. Blackie CA, Coleman CA, Holland EJ. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clin Ophthalmol. 2016; 10: 1385-1396.

    6. Lane SS et al. A New System, the LipiFlowTM, for the Treatment of Meibomian Gland Dysfunction (MGD). Cornea. 2012;31(4):396-404.

    7. Blackie C, Carlson AN, Korb DR. Treatment for meibomian gland dysfunction and dry eye symptoms with a single-dose vectored thermal pulsation: a review. Current Opinion in Ophthalmology. 2015; 26(4):306 13.

     

    SUMMARY OF IMPORTANT SAFETY INFORMATION

    Rx Only

    FOR THE TEARSCIENCETM LIPIFLOWTM THERMAL PULSATION SYSTEM

    INDICATIONS FOR USE

    The TearScienceTM LipiFlowTM System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including Meibomian Gland Dysfunction (MGD), also known as Evaporative Dry Eye or Lipid Deficiency Dry Eye.

    CONTRAINDICATIONS

    Do not use the TearScienceTM LipiFlowTM System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.

    • Ocular surgery within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
    • Ocular injury within prior 3 months
    • Ocular herpes of eye or eyelid within prior 3 months
    • Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
    • Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
    • Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
    • Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)

    PRECAUTIONS

    The TearScienceTM Activator (Disposable) may not fit all eyes, such as eyes with small palpebral fornices. Use of the TearScienceTM LipiFlowTM System in patients with the following conditions may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.

    • Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
    • Severe (Grade 3 or 4) eyelid inflammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid inflammation should be treated medically prior to device use
    • Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjögren's syndrome)
    • Taking medications known to cause dryness (e.g., isotretinoin (AccutaneTM) and systemic antihistamines)
    • Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing)

    In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.

    ADVERSE EFFECTS

    Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in

    • Eyelid/eye pain requiring discontinuation of the treatment procedure
    • Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion)
    • Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)
    • Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light)

    Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical intervention to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include:

    • Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens
    • Physical pressure-induced injury to the eyelid
    • Ocular surface (corneal) infection

    PP2023TS4026