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® G o in with c onfidence Choose the game-changing performance of ALCON ® MIVS for every challenge.

Transcript of Go in with confidence - Eyetube.net MIVS... · ALCON® MIVS procedure – 3 days post-op 20-gauge...

Page 1: Go in with confidence - Eyetube.net MIVS... · ALCON® MIVS procedure – 3 days post-op 20-gauge procedure – 3 days post-op Reduced Discomfort, Faster Recovery The micro-incision

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Go in with confidence

Choose the game-changing performance of ALCON® MIVS for every challenge.

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Essential Components of the CONSTELLATION® Vision System

The ALCON® MIVS (Micro-Incision Vitrectomy Surgery) product suite provides unparalleled versatility, stability and control to handle most surgical challenges with ease:

• Faster visual recovery and reduced discomfort1, 5, 6

• Improved stiffness, flow and versatility2

• Linear incisions and optimized wound closure with the EDGEPLUS® blade3

• True IOP control via new valved cannulas4

• A complete micro-incision portfolio for every step of the procedure

Why I Choose Small Gauge…“Small-gauge technology is the most important advancement in vitreoretinal surgery in 20 years. Improvements in the probe design reduce pulsatile traction on the retina without fluidic compromise. I use 25+® for all my cases, including the most complex. For the patient, MIVS surgery means faster healing,5 reduced discomfort 6 and expedited visual recovery.1”

— Steve Charles, MD* Memphis, TN

*Steve Charles, MD, is a paid consultant for Alcon. Please refer to the back cover for important safety information about these products.

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ALCON® MIVS procedure – 3 days post-op 20-gauge procedure – 3 days post-op

Reduced Discomfort, Faster Recovery The micro-incision advantage of the ALCON® MIVS platform is also highly beneficial to your patients, with enhanced postoperative comfort and faster visual recovery.1 Compared to a typical 20-gauge procedure, a smaller incision size can have a big impact:

• More beneficial for your patients because of reduced discomfort6

• Helps patients heal faster and more comfortably because of small-gauge incisions5, 6

• Allows for reduced corneal astigmatism, less inflammation and less disruption to the conjunctiva7

Leaking sclerotomy may lead to postoperative hypotony. Vitreous traction has been known to create retinal tears and retinal detachments.

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High Performance ULTRAVIT® Probes

Precision when and where you need it most at speeds up to 7500 cpm – that’s the ULTRAVIT® promise. With the fastest cutting speeds available and proven fluidic efficiency, the innovative ULTRAVIT® probes are the primary component of any MIVS procedure. Available in 23, 25+® and 27+® gauges, they can significantly improve your surgical capabilities:

• Reduces iatrogenic tears and post-op complications8

• Dual pneumatic probe delivers efficient cutting and fluidics up to 7500 cpm and beyond

• Higher cut speeds create smaller bites and reduced resistance to flow, which result in less pulsatile traction on the retina9,10

• Allows surgeons to work closer to the retina with confidence

• Features improved stiffness, flow and versatility

• Micro-incision tools provide better access within the eye for complex cases

*Comparison of 5000 cpm to 7500 duty cycle with an ULTRAVIT® 25+® probe.

ULTRAVIT® 7500 cpm duty cycle offers a greater range of control*11

Traditional spring-driven probes have duty cycle limitations at high cut speeds, causing flow limitations.

With the dual pneumatic ULTRAVIT® High Speed Vitrectomy Probe, duty cycle variables are independent of cut rate.

7500 cpm

PROBE

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PROBE

80 60 40 202500 cpm

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0% = Port always closed100% = Port always open

% Duty Cycle

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Improved Wound Construction with the EDGEPLUS® Blade

With cutting-edge design and ergonomic ease-of-use for today’s vitreoretinal surgeons, the EDGEPLUS® trocar/cannula blades are the perfect complement for micro-incision performance:

• Creates flat, linear incisions for optimized wound closure3

• Chamfered hub design allows for ease of instrument access

• Sharp solid trocar blade allows cannulas to be inserted in one simple step

• Thin-wall metal cannula is designed to improve rigidity and reduce instrument friction

• Low-profile cannulas and plugs are designed to minimize interference

Standard Blade

EDGEPLUS® Blade

Enhanced EDGEPLUS® Valved Trocar Cannula System

The EDGEPLUS® Valved Trocar Cannula System eliminates the need for plugs, and helps reduce instrument exchanges:

• Provides a closed system for true IOP control for any type of case

• After insertion, the cannula detaches easily from trocar without the use of a secondary instrument

• Low friction valves are designed for smooth instrument exchanges

The closed loop system of the CONSTELLATION® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure.

*Carl Claes, MD, is a paid consultant for Alcon. Please refer to the back cover for important safety information about these products.

“IOP stability with the CONSTELLATION® Vision System, matched with the valved cannulas,

may reduce perioperative pressure changes that might affect outcomes.” — Carl Claes, MD* Antwerp, Belgium

EDGEPLUS® Valved Entry System and Cannula

23G 25+® 27+®

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A Complete ALCON® MIVS Portfolio

No MIVS surgical procedure is complete without ancillary accessories. Alcon provides a robust line of products to support 23G, 25+® and 27+® surgeries:

Illuminated Flex-Curved Laser Probe

Chandelier Lighting System

PUREPOINT ® laser probes offer the ultimate level of functionality and control

* 27+® series only. Please refer to the back cover for important safety information about these products.

GRIESHABER® DSP single-use instrumentation provides a compliant, sterile instrument for every procedure

GRIESHABER® REVOLUTION™ DSP

Reusable Handle with GRIESHABER® Advanced DSP Tip

End-grasping forceps

ILM forceps Asymmetrical forceps

Fine Tissue

Vertical scissorsCurved scissors MAXGrip™ forcepsSerrated forceps Straight scissors*

Heavy Tissue

ALCON® endoilluminators allow for improved versatility and visualization during surgery

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© 2016 Novartis 1/16 US-GAU-15-E-1252

MIVSCAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATIONS FOR USE: The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

The ULTRAVIT® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas.

WARNINGS AND PRECAUTIONS: • The infusion cannula is contraindicated for use of oil infusion.• Attach only Alcon supplied products to console and cassette luer fittings. Improper usage or assembly could result in a potentially hazardous condition for the patient. Mismatch of surgical components and use of settings not specifically adjusted for a particular combination of surgical components may affect system performance and create a patient hazard. Do not connect surgical components to the patient’s intravenous connections.• Each surgical equipment/component combination may require specific surgical setting adjustments. Ensure that appropriate system settings are used with each product combination. Prior to initial use, contact your Alcon sales representative for in-service information.• Care should be taken when inserting sharp instruments through the valve of the Valved Trocar Cannula. Cutting instrument such as vitreous cutters should not be actuated during insertion or removal to avoid cutting the valve membrane. Use the Valved Cannula Vent to vent fluids or gases as needed during injection of viscous oils or heavy liquids.• Visually confirm that adequate air and liquid infusion flow occurs prior to attachment of infusion cannula to the eye.• Ensure proper placement of trocar cannulas to prevent sub-retinal infusion.• Leaking sclerotomies may lead to post operative hypotony.• Vitreous traction has been known to create retinal tears and retinal detachments.• Minimize light intensity and duration of exposure to the retina to reduce the risk of retinal photic injury.

ATTENTION: Please refer to the CONSTELLATION® Vision System Operators Manual for a complete listing of indications, warnings and precautions.

CONSTELLATION® VISION SYSTEMINDICATIONS FOR USE: The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

The PUREPOINT® Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including: • Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation

of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); choroidal neovascularization secondary to age-related macular degeneration; retinal tears and detachments; macular edema, retinopathy of prematurity; choroidal neovascularization; leaking microaneurysms.

• Iridotomy/Iridectomy for treatment of chronic/primary open angle glaucoma, acute angle closure glaucoma and refractory glaucoma.

• Trabeculoplasty for treatment of chronic/primary open angle glaucoma and refractory glaucoma.

• And other laser treatments including: internal sclerostomy; lattice degeneration; central and branch retinal vein occlusion; suturelysis; vascular and pigment skin lesions.

The FlexTip* laser probe is intended to be used with ALCON® 532nm laser systems.

CONTRAINDICATIONS: • Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber of vitreous humor) are poor candidates for LIO delivered laser treatments.• The infusion cannula is contraindicated for use of oil infusion.

COMPLICATIONS: Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration is used.

WARNINGS AND PRECAUTIONS:• The disposables used in conjunction with ALCON® instrument products constitute a complete

surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

• Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient’s intravenous connections.

• Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.

• Vitreous traction has been known to create retinal tears and retinal detachments.

• The closed loop system of the CONSTELLATION® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.

• Leaking sclerotomy may lead to post operative hypotony.• Back scattered radiation is of low intensity and is not harmful when viewed through a

protective filter. All personnel in the treatment room must wear protective eyewear, OD4 or above at 532nm, when the system is in Standby/Ready mode as well as during treatment. The doctor protection filter is an OD greater than 4 at 532nm.

ATTENTION: Please refer to the CONSTELLATION® Vision System Operators Manual for a complete listing of indications, warnings, and precautions.

IMPORTANT SAFET Y INFORMATION: WARNINGS AND CAUTIONS: A complete listing is available in the CONSTELLATION® Vision System Operators Manual. To obtain a copy, please contact Alcon Customer Service.

ATTENTION: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

GRIESHABER® DSP INSTRUMENTATIONCAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATIONS FOR USE: GRIESHABER® DSP instruments are a line of single-use vitreoretinal micro-instruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER® Advanced Backflush Handles DSP are a family of instruments for fluid and gas handling in vitreoretinal surgery.

WARNINGS AND PRECAUTIONS: • Potential risk from reuse or reprocessing GRIESHABER® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fluidics performance.• Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery.• For light fiber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON® illumination source.• Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics response will be jeopardized.• Use appropriate pressure supply to ensure a stable IOP.• If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument. ATTENTION: Please refer to the product labeling for a complete listing of indications, warnings, and precautions.

ILLUMINATIONCAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

CAUTION: This document is not intended to substitute for the necessity of reading and understanding the light source Operator’s Manual.

INDICATIONS AND USAGE: Fiber Optic Instruments with ENGAUGE® Radio Frequency Identification Device (RFID) for use with the CONSTELLATION® System. These instruments can be used on the ACCURUS® System or ACCURUS® High Brightness Illuminator (AHBI) using the RFID Adapter Model Number 8065751140.

WARNINGS AND PRECAUTIONS:• Minimize the light intensity and duration of exposure to the retina to reduce risk of retinal

photic injury.• Avoid operation of a fiber in air on consoles capable of illumination levels and settings higher

than 10 lumens. This may result in fiber probe deformation and/or high surface temperatures that may cause patient injury.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

VITREORETINAL LASER PROBEINDICATION: ALCON® Laser probes are fiber optic probes indicated for use with an ALCON® Laser System. Each package contains individually packaged sterile laser probes.

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

WARNINGS/PRECAUTIONS: • Do not use if package is damaged.• Minimize the illuminator’s light intensity.

*Trademarks are property of their respective owners.

IMPORTANT SAFETY INFORMATION

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To see how the ALCON® MIVS portfolio of tools can help improve your vitrectomy performance, visit AlconRetina.com

1. Nagpal M, et al. Comparison of clinical outcomes and wound dynamics of sclerotomy ports of 20, 25, and 23 gauge vitrectomy. Retina. 2009.2. Avery R. Single surgeon experience with an enhanced 25+ vitrectomy probe/entry system. ASRS Poster, 2009.3. Inoue M, et al. Comparison of blade and incision architecture between new 25- and 23-gauge microvitreoretinal blades and current sclerotomy entry systems. ASRS Poster, 2011.4. Claes C, et al. Clinical and laboratory evaluation of valved cannulas. EVRS Presentation, 2010.5. Recchia FM, Scott IU, Brown GC, Brown MM, Ho AC, Ip MS. Small-gauge pars plana vitrectomy: a report by the American Academy of Ophthalmology. Ophthalmology.

2010 Sep;117(9):1851-1857.6. Mentens R, Stalmans P. Comparison of postoperative comfort in 20 gauge versus 23 gauge pars plana vitrectomy. Bull Soc Belge Ophtalmol. 2009;(311):5-10.7. Avitabile T, et al. Transconjunctival sutureless 25-gauge versus 20-gauge standard vitrectomy: correlation between corneal topography and ultrasound biomicroscopy

measurements of sclerotomy sites. Cornea. 2010; Jan;29(1):19-25.8. Rizzo S, et al. Comparative study between a standard 25-gauge vitrectomy system and a new ultra high-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal

diseases. Retina. Vol 31:2007-2013, 2011.9. Hubschman, et al. 20-, 23- and 25-gauge vitreous cutters performance and characteristics evaluation. Retina. 2008 Feb:28(2):249-57.10. Teixeira, et al. An experimental protocol of the model to quantify traction applied to the retina by vitreous cutters, IOV.S 2010 Aug;51(8):4181-4186.11. Relationship of duty cycle vs cut rates for the commercially available vitrectomy systems: Novack, R., Zhou, J., Abulon, D., Guboltz, D., ASRS Poster 2010.