CORNEAL AND REFRACTIVE SURGERY IN A NEW DIMENSION The FEMTO LDV Femtosecond Surgical Laser for LASIK and Corneal Surgery

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1 EXCITINGLY CLEVER CORNEAL AND REFRACTIVE SURGERY IN A NEW DIMENSION The FEMTO LDV Femtosecond Surgical Laser for LASIK and Corneal Surgery

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3 Look beyond the obvious and the established discover a new dimension

4 Welcome to a new dimension Perfect for you ideal for your patients Refractive surgeons and patients alike have been looking for alternatives for creating the corneal lenticule (the flap ) as the initial step in laser assisted in-situ keratomileusis ( LASIK ). The wish to offer patients an all-laser LASIK option has stimulated demand for femtosecond lasers, as they offer the potential of cutting corneal tissue with extremely short laser pulses, without generating heat. Femtosecond lasers have been in routine use in refractive surgery for several years now. While surgeons have reported favorably on the quality of outcomes and on patient satisfaction, the sheer bulk and inflexibility of available femto lasers, and their complex operation and maintenance have been perceived as obstacles to wider acceptance and to a more widespread use for different corneal surgery applications. Ziemer s FEMTO LDV, the first compact, mobile femto second surgical laser system, has been conceived to provide a versatile, powerful platform for a wide spectrum of applications in corneal surgery. The basic system presented in this brochure addresses the demand of refractive surgeons for an all-laser LASIK capability that is consistent with their efficient, complication-free LASIK workflow and provides the basis for perfect outcomes in laser vision correction. The optional LCS Module extends the range of surgical modalities of the FEMTO LDV to include lamellar corneal surgery applications such as creating intrastromal incisions for implanting intracorneal rings and inlays, and lamellar keratoplasty. This wide range of applications is based on a revolutionary femtolaser design concept that provides precision, versatility, and tissueprotecting low-energy cutting performance.

5 Expand in every direction The Ziemer all-around concept 1 The laser that delivers outstanding clinical results Robust, single-stage, solid-state laser source High-pulse repetition rate resulting in superior tissue resection characteristics Unique precision optics creates smooth tissue separation with minimal effect on neighboring tissue 3 Comprehensive customer support ensures high uptime and hassle-free operation Service-friendly, modular design keeps downtime to a minimum Self-checking and self-adjusting Remote diagnostics and adjustment 2 The productivity tool that integrates into your surgical workflow Forms a single workstation with your excimer laser Simplified patient flow Transfers diagnostic and patient data directly to the laser 4 The Z-LASIK marketing toolkit helps deliver your message and educate your patients Patient education materials Website building and advertising / PR materials The powerful Z-LASIK brand that sets you apart LASIK 1 Technology and innovation, LASIK, LCS LCS 4 2 Practice marketing ALL-AROUND CONCEPT Productivity, surgical workflow patient throughput 3 Service and support

6 Become part of the innovation A radically new approach to Femtolaser technology Most femtosecond lasers currently on the market are based on the same basic technology that has been in use in femtolasers since they were introduced to ophthalmology several years ago. Laser sources operating at tens to hundreds of kilohertz are fed to analog amplifiers to achieve high pulse energies for creating large cavitation bubbles to disrupt corneal tissue. Ziemer s FEMTO LDV is based on a radically different technology. Operating at pulse frequencies in the megahertz range and using high-aperture optics, the threshold for tissue disruption is reached without requiring an amplifier and at very short interaction times that effectively prevent any thermal effects from occurring in the tissue. The result is clean tissue dissection without thermal or radiation-related side effects. The unique features of Ziemer s femtolaser technology All solid-state, non-amplified laser achieves high stability Very high pulse rates and ultra-short femtosecond pulses Low pulse energy Small, tightly overlapped dissection spots No interstitial, un-dissected spaces giving rise to tissue bridges High-aperture optics assure perfect depth focus Fixed focus optics ensure precise cutting depth The benefits of Ziemer s femtolaser technology Smooth, even cutting surfaces Even incision depth Tissue disruption is achieved without thermal effect No tissue damage and complications from high pulse energies, such as opaque bubble layer (OBL), transient light sensitivity (TLS), or diffuse lamellar keratitis (DLK) Rapid healing and visual recovery The FEMTO LDV is a clinically useful workhorse; reliable, easier to use and with a lower complication rate than other femtolasers. Theo Seiler, MD, PhD, Zurich, Switzerland Laser energy is delivered to the eye through an articulated arm and a hand-held scanning device, which affords a direct view of the applanated cornea. Tightly focused low-energy laser pulses generate overlapped spots of dissected tissue and minuscule cavitation bubbles, resulting in a complete, smooth resection.

7 Integrated work-flow Due to its unique hand-held laser delivery system, which is attached to an easily maneuverable articulated arm, patients can be treated on the patient bed of the excimer laser and need not be relocated between flap creation and ablation procedures. The surgeon performs and controls the entire procedure from a single working position, without having to move about or change microscopes. This revolutionary design concept entails several major advantages in clinical practice: As the FEMTO LDV s laser energy is deployed from a handpiece, which is placed on the patient s eye and manually controlled by the surgeon, the procedure resembles that of a traditional microkeratome. For fixation, the handpiece incorporates a vacuum suction ring. The sterile single-use parts of the handpiece, which are provided in convenient, assorted Procedure Packs, are assembled before the procedure is started and before the patient s eye is touched. Similarly, the components are disassembled after the complete (usually bilateral) procedure is completed. Tactile and visual control A precise vacuum is generated and maintained by a computer-controlled system which employs the proven technology of the AMADEUS microkeratome (developed by SIS Surgical Instrument Systems Ltd, another Ziemer Group company). Optimized vacuum level and short vacuum time ensure minimal stress to the globe. The unique handpiece of Ziemer s FEMTO LDV system gives the surgeon full tactile and visual control and guidance while observing the treatment field both through the excimer laser s built-in operating microscope and the high-resolution digital TopView camera built into the handpiece. a c b (a) The stream of pulses scanning across the cornea creates a pattern of fine gas bubbles. (b) Upon lifting the flap, the bubbles disappear instantly, leaving a clear, smooth stromal bed (c) that can be subjected to laser ablation without any waiting time. (d) Enlarged view of ablated stromal bed. d

8 Advance to a higher level Intelligent system design Smooth tissue separation A novel, proprietary laser cutting process developed specifically for Ziemer s FEMTO LDV system provides for effortless, gentle and complete tissue separation. The process generates minuscule bubbles that help visualize the flap edge for easy opening. The bubbles disintegrate instantly when the flap is lifted. Consequently, the excimer laser ablation process may be initiated immediately after completion of the flap cutting process, saving time and minimizing exposure of stroma. Versatile flap control Flap dimensions are computer-controlled and set through an intuitive set of parameters via a user-friendly graphical interface and touch-screen. Hinge position, hinge angle and width, flap diameter and thickness are selected by the surgeon to create a customized flap optimized to bulbus dimensions and surgical requirements. There are no parts moving on the cornea; hence less trauma to the epithelium than with mechanical microkeratomes.

9 Flexible resection patterns The FEMTO LDV s flexibility is exemplified by the incredible amount of control over resection geometry available for creating intra-stromal rings: separate incisions for each ring segment, individual sizing and positioning of segments, precisely controlled tunnel width and depth for optimum visual effect, specially shaped insertion ports for easy ring implantation, pre-stored tunnel shapes for all current models of corneal rings (Intacs, Kerarings, Ferrara rings, and others). The TopView camera The recently introduced MkII LASIK handpiece and the optional LCS handpiece for lamellar corneal surgery applications both feature the built-in TopView camera. It provides a large real-time image of the applanated patient eye. Controlling flap centration and size, as well as positioning of lamellar incision patterns is made more precise and safer with the camera, while the option of viewing the applanation area directly by means of an operating microscope has been retained. TopView camera features: Large mm real-time view of eye on the system monitor Control of brightness and contrast for optimal visibility Selected flap size / incision pattern is projected onto the image User-selectable centration marks Automatic pupil detection Position of dissection pattern may be shifted on the applanated eye in 25 µm increments Fixation light helps patients maintain fixation and reduces centration errors Operating microscope is not required for centering and cutting Free direct view through handpiece is maintained

10 Play in the top league Z-LASIK with the FEMTO LDV Based on the clinical experience of more than 100,000 successful femto-lasik procedures, the FEMTO LDV stands out as the femtosecond laser with a remarkably low complication rate, as a device that is robust, easy and safe to handle. In conjunction with state-of-the-art excimer lasers, the FEMTO LDV achieves superior shortterm results as well as excellent long-term visual outcomes in femto-lasik procedures. FEMTO LDV: the top-performing platform for femto-lasik The unique design of the FEMTO LDV laser delivery system features a hand-piece with fixed-focus, high aperture optics that generates planar, large flaps with smooth, tapered edges, with highly predictable flap dimensions and reproducible flap thickness. The high pulse repetition rate and low pulse energy generate laser spots that are tightly overlapped to produce a smooth, completely dissected incision. Flaps can be easily lifted, leaving the eye quiet, free of edema, and free of radiation-related complications such as opaque bubble layer (OBL), transient light sensitivity (TLS), or laser-induced diffuse lamellar keratitis (DLK). With these characteristics, the FEMTO LDV is ideally suited to generate thin, sub-bowman, flaps that are biomechanically stable and easy to manipulate. Stromal beds are smooth and dry, the ideal prerequisite for predictable ablation with the excimer laser. Large corneal flaps Uniform, reproducible flap thickness Thin, sub-bowman (SBK) flaps No tissue bridges (incomplete tissue dissection) Smooth, self-sealing flap edges Planar flaps Quiet eyes Dry bed for predictable ablation No occurrence of OBL, TLS, DLK and other complications related to excessive pulse energy No suction breaks I have a Ziemer laser in my office and have been very happy with it. It produces very reproducible flaps and they are much easier to lift than with other femtosecond lasers. No opaque bubble layer at all. Gregg Feinerman, MD, Feinerman Vision Center, Newport Beach, CA, USA

11 Superior clinical outcomes FEMTO LDV users report high levels of customer satisfaction with their Z-LASIK procedures: Within hours after the procedure, patients have excellent vision. The percentage of patients achieving 20/20 or better uncorrected visual acuity on the first post-op day is reported as 95% and more, a performance that requires several weeks of healing for LASIK procedures based on other flap making techniques (other femtosecond lasers or microkeratomes). Statistical analysis of treatment data has also revealed that better results (lower high-order aberrations) are achieved with the large (9.5 mm) flaps that can be prepared with the FEMTO LDV. Other studies have documented superior visual performance with 90 μm flaps compared to >100 μm flaps. Short-term (1 day) uncorrected visual acuity superior to other femtosecond lasers Medium-term (1 6 weeks) uncorrected visual acuity superior to mechanical microkeratomes 9.5 mm flaps superior to 9 mm flaps 90 μm flaps superior to 110 μm 100% 100% 90% 80% 70% other femtolaser 83% Ziemer 75% 60% 63% 50% 40% 35% 30% 20% 10% 14% 14% 0% 20/12.5 or better 20/16 or better 20/20 or better 20/25 or better 20/40 or better 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 9.0 mm 9.5 mm 44% 56% 72% 83% 91% 84% 100% 20/16 20/20 20/25 20/40 The FEMTO LDV outperforms other femtosecond lasers in the quality of vision achieved immediately after surgery. The graphic compares uncorrected visual acuities measured 1 day postoperatively (D. Durrie MD, data presented at ASCRS 2008, Chicago). The FEMTO LDV s larger flap diameters contribute to the superior short-term visual results achievable with this platform. The graphic compares uncorrected visual acuities 1 month postoperatively from 9.0 mm vs. 9.5 mm flap diameters with the FEMTO LDV (Ch. Moore, MD, data presented at ASCRS 2008, Chicago).

12 Extend your capabilities Corneal surgery with the FEMTO LDV The optional LCS Module bestows additional surgical capabilities onto the FEMTO LDV, making it an even more productive, versatile device. Intracorneal Rings (ICR) are becoming more and more popular for managing keratoconus (KC) and as an alternative modality for correcting refractive errors. However, creating the required intrastromal tunnel incisions with manual tools is difficult, imprecise, and prone to complications. With the FEMTO LDV, tunnel incisions may be shaped and positioned with a degree of precision that cannot be reached with other methods and other femto -second lasers. This enables the experienced surgeon to achieve high levels of visual performance with corneal ring implants. Available 6-month follow-up data indicate high stability and good tolerability of implants. Intrastromal Inlays hold promise as alternative solutions for reversibly correcting minor refractive errors, and particularly as a new form of presbyopia treatment. With the FEMTO LDV, pocket incisions can be crafted and positioned with a high degree of precision, thereby greatly improving the predictability, effectiveness, and stability of such procedures. Lamellar Keratoplasty (LK) is often the method of choice where diseased corneal tissue must be substituted with a graft from donor tissue. In the past, outcomes of LK procedures have been hampered by the difficulty of obtaining a smooth, even stromal bed to receive the graft. With the FEMTO LDV s excellent cutting performance, perfect beds may be prepared even if this requires cutting through opacified or scarred tissue. By means of an artificial anterior chamber designed specifically for the FEMTO LDV, perfect donor buttons can be excised. Setting the trajectory parameters for a intrastromal pocket incision is straightforward with the FEMTO LDV s trajectory editing capabilities. Position of insertion tunnel and of manipulation tunnel (if required) can be set at any angle. Microscope view of an implanted AcuFocus intrastromal inlay. Precise positioning is essential for maximum visual effect. Insertion of rings is easy to perform, because there are no tissue bridges. Paul Stodulka, MD, Zlin, Czech Republic

13 Features of the optional Lamellar Corneal Surgery Module: Cutting depth 200 to 450 µm Large excision diameters Predictable excisions with well-defined dimensions Donor tissue may be used for 2 grafts (ALK / DSAEK) Convenient nomograms for all types of corneal rings Separate superior and inferior tunnels may be created with different dimensions Self-sealing incision for inserting ring segments created with micrometercontrolled diamond blade TopView camera allows placement of incisions with 25 μm accuracy under full visual control Setting the trajectory for creating a circular tunnel incision for implanting two Keraring segments. Size and position of all segment parameters may be set individually. In the camera view of the applanated eye, trajectory outline and centration marks are displayed. Center of trajectory may be adjusted in 25 μm increments to allow highly precise positioning of the incision for optimum visual results. Microscope view of an implanted Keraring segment. Untraumatic insertion and precise dimensioning of the tunnel incision result in a quiet eye and in secure ring placement at the desired position.

14 Reach the competitive edge The FEMTO LDV as an excellent productivity tool Surgeons who use the FEMTO LDV in their LASIK practice testify that the LDV has improved their productivity dramatically. It allows them to integrate femtolaser and excimer laser into a single workstation. Neither the patient nor the surgeon need to move, and the treatment is a single, un-interrupted process without any waiting times. This leads to better outcomes and to a simplified patient flow. And it makes Z-LASIK a less intimidating and less protracted process for the patient. Reportedly lower complication rates mean fewer complications to manage and fewer retreatments. This reduces costs and improves patient satisfaction. Considering the lower running cost and lower per-procedure cost and the dramatically higher system availability due to minimal downtime, the FEMTO LDV is simply the best and most productive investment you can make. Shorter overall procedure times in LASIK optimizes patient throughput Integrated flap creation and ablation process minimizes stroma exposure time Fewer complications to manage Fewer retreatments Lower initial investment (no extra cost for facility upgrading, air conditioning, etc.) Lower running cost due to lower maintenance requirements Higher uptime; lower downtime with remote servicing Higher productivity by mobile (multi-site) use High patient satisfaction high rate of patient referrals With better patient results achieved faster, Z-LASIK brings back the Wow! to LASIK. Z-LASIK is a fantastic practice builder. Nancy A. Tanchel, MD, Vienna, VA, USA

15 Build on traditional Swiss values Top quality, service and support Service and maintenance The FEMTO LDV sports an extremely sturdy, all solid-state design that is entirely digitally controlled. The laser is insensitive to shock and to changes in environmental conditions. Therefore, the FEMTO LDV can be operated for prolonged periods of time without any need for adjustments by the operator or by service personnel. Selfadjustment routines and digital control of all vital instrument functions ensure stable performance even if temperature or humidity changes occur. Ziemer engineers in the 24hr helpline customer support team can access any FEMTO LDV system online over an Internet connection and perform system checks and adjustments on the spot. Therefore even if a malfunction should occur, your FEMTO LDV may be operational again without prolonged disruption of surgery operations. Installation and after sales support At the time of installation, Ziemer engineers and clinical support staff administer in-depth training to surgeons and to assisting staff, including wetlab training and live surgery assistance. Ziemer issues certificates of completion to all individuals who have completed the training program. For advanced operations, Ziemer provides additional expert training programs. Software upgrades that improve performance and functionality of your FEMTO LDV system can be installed automatically over your system s Internet connection. An expert users panel is available to all users to provide peer support and advice via our webbased Users Forum. Ziemer R&D engineers are continuously at work developing new capabilities and improving the performance and safety of the FEMTO LDV platform. As an example, the Lamellar Corneal Surgery Module and the TopView camera have recently been announced as a part of our ongoing effort to expand the usefulness and the usability of the FEMTO LDV system. Maintenance interval: 6 months or 4000 procedures Remotely serviceable online (requires Internet connection) Laser may be moved, even while running Laser source and optics are designed for extended lifetimes Built-in automatic control and adjustment of key performance parameters

16 Extend your advantage Developing your refractive business with Ziemer As a successful, and demanding, refractive surgeon, you have some essential needs: You need a refractive suite of surgical tools that allows you to maintain an efficient workflow. You want to set your practice apart from the mass market. You are looking for better, more efficient ways to reach your customers, the large numbers of ametropic people of all generations, from 20 to 50, who have been waiting for the right moment, the right surgeon, and the right technology to make the transition to a life without glasses and contact lenses. You need tools for patient education that help generate patients efficiently and that create the right framework of patient expectations.

17 Z-LASIK marketing toolkit You have the surgical skill and expertise. Ziemer delivers the technology, the quality, and the performance. And Ziemer helps you reach your market with its Z-LASIK marketing toolkit. It includes these services and options: With the purchase of your Ziemer FEMTO LDV you receive a free initial supply of Z-LASIK leaflets for your patients. Text and visual materials for developing media advertisements, press releases, and blasts. Tools and elements for building your Z-LASIK Practice Website. The Find a Z-LASIK Doctor service on The Z-LASIK Patient Information Video, a video clip that you can integrate into your video material. The LVC Counselor software and vision simulator is a patient education software program that provides your practice with a dynamic and systematic approach to educating laser vision correction candidates. It helps increase the number of patients who say YES to laser vision correction by allowing them to visualize the benefits of Z-LASIK based on their individual situation. This unique program by Patient Education Concepts, Inc. is sponsored by Ziemer Group. Press releases Website blasts Marketing toolkit Advertising Information video Educational literature Vision simulator

18 Specifications FEMTO LDV System Specifications Laser Type Mode-locked, diode-pumped Yb oscillator Mode Fundamental (TEM00) Central Laser Wavelength 1045 nm ±10 nm Laser Pulse Duration fs Laser Class 4 Remote Interlock Yes Base Station Footprint 95 cm (L) 70 cm (W) 76 cm (H) System Height 100 cm (floor to articulating arm) 139 cm (floor to top of screen) System Weight 215 kg Input Voltage & 100/120/ VAC, Hz; 700 VA Maximum Current Interfaces USB 2 / Ethernet / ext. interlock / foot pedal Ambient Operating 18 to 24 C (65 to 75 F), 20 to 70% rh Conditions Recommended Storage 10 to 50 C (50 to 122 F), 20 to 70% rh Conditions Recommended Transport -20 to 60 C (-4 to 140 F), 10 to 90% rh Conditions not condensed Atmospheric pressure 500 hpa to 1060 hpa range Application Specifications (LASIK) Time to create a flap < 30 secs from suction on to suction off Flap dissection time 15 to 20 secs (depending on flap size) Flap diameter 8.5, 9.0, 9.5, 10.0 mm Flap Thickness 90, 100, 110, 140 µm Eye Fixation Suction ring and computer controlled vacuum system Hinge position and width Selectable Application Specifications (Lamellar Corneal Surgery) Resection depth µm Intracorneal tunnels Ring diameter, tunnel width, segment following parameters angles, insertion position, width of may be set insertion port, incision depth Intrastromal pockets for Pocket size and depth, width of inlays insertion port and of (optional) manipulation port Lamellar Keratoplasty Depth of resection; diameter of resection; of graft (with artificial anterior chamber) 2009 Ziemer Ophthalmic Systems AG Actual product characteristics, specifications, and prices are subject to change. Document No. FL Product Information Manufacturer: SIE Surgical Instruments Engineering AG, CH-2562 Port, Switzerland (a Ziemer Group Company) Sales & Service: Ziemer Ophthalmic Systems AG, CH-2562 Port, Switzerland and its network of established ophthalmic equipment distributors. Visit for details. Availability: Europe: CE-marked. USA: FDA 510(k) cleared. For other countries, availability may be restricted due to local regulatory requirements; please contact Ziemer for details. Configuration: self-contained system on wheels, height-adjustable. With hand-held laser beam delivery module, mounted on a weight-compensated, articulated arm. Built-in computer system includes touch-screen color monitor and foot-switch. Integrated, automatic, computer-controlled suction system. Consumables: For each patient treatment, a single-use Procedure Pack is required, each containing one set of sterile handpiece casings, one suction ring with InterShield spacer, vacuum tubing, and sterile drape. Each Procedure Pack is coded for the dimensions of suction ring and InterShield spacer and automatically detected by the system. Service: Regular Maintenance and Repair Service is available from the manufacturer and from local certified Service Centers (please contact your local distributor or consult the Ziemer website for address information). Automatic self-checks and self-adjustment routines are built into system. Ziemer Service Hotline can provide instant online diagnostics and repair (Internet connection required) Convenient Maintenance and Service Contracts are available. Warranty: Ziemer s FEMTO LDV system comes with a 12-month limited warranty on parts and workmanship. Please consult Ziemer Ophthalmic Systems Warranty Terms for details. Headquarters, International Sales & Support Ziemer Ophthalmic Systems AG a Ziemer Group Company Allmendstrasse 11 CH-2562 Port, Switzerland Phone: Fax: innovation@ziemergroup.com Sales & Support USA Ziemer USA, Inc. a Ziemer Group Company #1 Enviroway, Suite 300 Wood River, Illinois 62095, USA Phone: Fax: usa@ziemergroup.com

19 Ziemer Group is a privately owned, Switzerland-based med-tech company, whose activities are focused exclusively on ophthalmology. At Ziemer we strive to empower ophthalmologists and optometrists to deliver better vision care to their patients by creating superior surgical and diagnostic tools.

20 Ziemer Ophthalmic Systems AG a Ziemer Group Company Allmendstrasse Port Switzerland Phone: +41 (0) Fax: +41 (0) innovation@ziemergroup.com