TearScience LipiFlow Thermal Pulsation System

TearScience™ LipiFlow™ Thermal Pulsation System
The TearScience LipiFlow Thermal Pulsation System is a medical device used  by physicians in addressing Meibomian Gland Dysfunction (MGD).
TearScience™ LipiFlow™ Thermal Pulsation System
The TearScience LipiFlow Thermal Pulsation System is a medical device used  by physicians in addressing Meibomian Gland Dysfunction (MGD).

Key Features

Built for efficiency

A translucent design for proper positioning of TearScience Activator Clear.

Built with environment in mind

Redesigned TearScience Activator Clear, with fewer raw materials than its predecessor

Built for performance

Precise, automated, bilateral application of heat and pressure across entire lid.
Woman with pulsation system cups on her eyes

Designed to Improve Gland Function

The TearScience LipiFlow Thermal Pulsation System 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 TearScience LipiFlow System to treat MGD patients in-office with confidence and efficiency.

The Science Behind TearScience LipiFlow

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

Vectored

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.

Thermal

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

Pulsation

Intelligent pressure feedback loop sends pulsation 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.

Animated visual representation of pulsating therapy on the eye.

Process to Improve Gland Function

The TearScience LipiFlow 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.

Patient Messaging

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
  • TearScience LipiFlow 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
  • TearScience LipiFlow installations are evenly divided between ophthalmology and optometry clinics
  • TearScience LipiFlow is available in more than 1500 practice locations in the United States and Canada as of January 2023

Learn More

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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://tearcare.com
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 LipiFlow, 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 TEARSCIENCE LIPIFLOW THERMAL PULSATION SYSTEM

INDICATIONS FOR USE
The TearScience LipiFlow 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 TearScience LipiFlow 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 TearScience Activator (Disposable) may not fit all eyes, such as eyes with small palpebral fornices. Use of the TearScience LipiFlow 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 (Accutane®) 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

PP2023OTH5148

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