Overview iTrack™ iTrack™ Advance Molteno3®

ADVANCING CANALOPLASTY TO THE NEXT LEVEL

For over a decade, Nova Eye’s proprietary iTrack™ canaloplasty microcatheter has been used across the globe to effectively treat more than 120,000 glaucoma patients.* Building on this proven track record we are proud to introduce the next generation of iTrack™ – iTrack™ Advance.

1. Khaimi, M. A., Dvorak, J. D., & Ding, K. (2017). An analysis of 3‑year outcomes following canaloplasty for the treatment of open-angle glaucoma. Journal of ophthalmology, 2017.

If we go back and look at our basic science series book and talk about outflow and resistance, we note that there’s disease throughout the entire continuum of the outflow system. It’s actually addressed when we viscodilate with the iTrack™ canaloplasty microcatheter.”

Mark J. Gallardo, MD

iTRACK™ ADVANCE IS DESIGNED TO TREAT ALL SITES OF OUTFLOW RESISTANCE IN THE CONVENTIONAL OUTFLOW SYSTEM — BOTH PROXIMAL AND DISTAL

Up to 75% of outflow resistance is localized within the trabecular meshwork.¹ The juxtacanalicular portion of the trabecular meshwork, which lies immediately adjacent to Schlemm’s canal, is thought to account for the majority of reduced outflow facility within the trabecular meshwork of POAG eyes. iTrack™ Advance is designed to separate the compressed trabecular plates within the trabecular meshwork.^3 – 5

1. Manik Goel, Renata G Picciani, Richard K Lee, and Sanjoy K Bhattacharya. Aqueous Humor Dynamics: A Review. Open Ophthalmol J. 2010; 4: 52 – 59.
2. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322.3. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504.4. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.

The dimensions of the lumen of Schlemm’s canal are smaller in POAG eyes¹ and can account for up to 50% of decreased outflow facility in POAG eyes.² iTrack™ Advance is designed to break adhesions within Schlemm’s canal, in addition to dilating the canal up to twice its size.^3 – 5

1. Johnstone MA, Grant WG. Pressure-dependent changes in structures of the aqueous outflow system of human and monkey eyes. Am J Ophthalmol. 1973;75:365 – 383 2. Allingham RR, de Kater AW, Ethier CR. Schlemm’s canal and primary open angle glaucoma: correlation between Schlemm’s canal dimensions and outflow facility. Exp Eye Res. 1996;62(1):101 – 109. 3. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322. 4. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504. 5. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.

Up to 90% of collector channels may be blocked by herniations of the trabecular meshwork in POAG eyes.^1,2 These herniations into the collector channels result in increased outflow resistance.^1,2 iTrack™ Advance works to push out herniations out of the collector channels and dilate the collector channels to reduce outflow resistance.^3 – 5

1. Gong H, et al. Reduction of the available area for Aqueous humor outflow and increase in meshwork herniations into collector channels following acute IOP elevation in bovine eyes. Invest. Ophthalmol Vis Sci 2008; 49:5346 – 5352. 2. Gong H and Francis A: Schlemm’s Canal and Collector Channels as Therapeutic Targets. In Innovations in Glaucoma Surgery, Samples JR and Ahmed I eds. Chapter 1, page 3 – 25, Springer New York, 2014.Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg. 1999;25(3):316 – 322. 3. Grieshaber MC, Pienaar A, Olivier J, Stegmann R. Clinical evaluation of the aqueous outflow system in primary open-angle glaucoma for canaloplasty. Invest Ophthalmol Vis Sci. 2010;51(3):1498 – 1504. 4. Smit BA, Johnstone MA. Effects of viscoelastic injection into Schlemm’s canal in primate and human eyes: potential relevance to viscocanalostomy. Ophthalmology. 2002;109(4):786 – 792.

Visit the iTrack™ Advance website
iTrack-Advance.com

Indications: The iTrack™ Advance has been cleared for the indication of fluid infusion and aspiration during surgery, and for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open-angle glaucoma. Contradictions: The iTrack™ Advance is not intended to be used for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in eyes of patients with the following conditions: neovascular glaucoma; angle closure glaucoma; and, previous surgery with resultant scarring of Schlemm’s canal.

Adverse events: Possible adverse events with the use of the iTrack™ canaloplasty microcatheter include, but are not limited to: hyphema, elevated IOP, Descemet’s membranedetachment, shallow or flat anterior chamber, hypotony, trabecular meshwork rupture, choroidal effusion, Peripheral Anterior Synechiae (PAS) and iris prolapse.

Warnings: Do not use the cannula to create an incision in the external tissues. Be careful when taking off the protective cap of the cannula to not break sterility by piercing the surgical drapes or gloves of the surgeon or technicians with the exposed cannula. The fiber optic line and infusion lines must not be pulled as these lines are attached to the back end of the iTrack™ Advance Handle when in use.

Precautions: Do not use product if the tamper proof seal has been broken. Do not use product if the pouch integrity has been broken. Do not remove the protective cover from the cannula until ready to use. Handle the iTrack™ Advance carefully to avoid damaging the device. Do not use product if the cannula cover is not attached to the handpiece. Do not use product if it appears to be damaged. Do not apply excessive force to the cannula cover or the actuator. Do not let the viscoelastic dry at the tip of the microcatheter, as this can cause the lumen to become occluded. Avoid touching the cannula with any surfaces as this may damage the precisely manufactured spatulated tip. Do not bend the cannula. Do not use excessive force when directing the Cannula and maintain visualization of the spatulated tip and microcatheter to avoid contacting and damaging unintended tissues. The microcatheter should be advanced and retracted slowly using the actuator, and the spatulated tip must be positioned correctly to prevent the microcatheter from being kinked or bent. Actuator withdrawal and of viscoelastic flow must be smooth, consistent, and continuous. Maintain visualization of the spatulated tip and microcatheter to avoid unintended tissue damage. When applicable, remove excess viscoelastic from the eye by irrigation and/or aspiration.

The iTrack™ Advance should be used only by physicians trained in ophthalmic surgery. Knowledge of surgical techniques, proper use of the surgical instruments, and post-operative patient management are considerations essential to a successful outcome.

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