CONTROLLED PRECISION. Introducing Avansee Preset, the new fully preloaded IOL system from Kowa Avansee Preset IOL is placed in the capsular bag and is designed for implantation after extracapsular cataract extraction or phacoemulsification of cataracts. 1
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CONFIDENCE THROUGH CONTROLLED PRECISION A fully preloaded IOL system For simple and efficient IOL delivery For safe and reliable IOL delivery For delivery of the Avansee lens AvanseePreset allows preparation for IOL insertion in two simple steps, saving time for both you and your nurses: 1 Inject the ophthalmic viscosurgical device (OVD) - 0.15ml 2 Remove the lens stage With AvanseePreset, IOL handling and manipulation are no longer required: ensuring sterility and accurate IOL loading reducing the risk of IOL damage and minimising the risk of infection AvanseePreset provides controlled and reproducible delivery of the Avansee lens, a foldable aspheric hydrophobic monofocal IOL. AvanseePreset is a lightweight syringe-type injector that allows IOL insertion with just one hand. 04 05
CONTROL BY DESIGN The original design of AvanseePreset - including the lubricated injector lining and the soft, flexible lens - offers a low, consistent and homogeneous force requirement for IOL delivery. 2 Minimising IOL damage or deformation during insertion 3 Facilitating accurate IOL insertion within the capsular bag 2 Reducing the risk of complications during surgery 2 Force required to expel an IOL from its injector into phacoemulsified porcine eyes Avansee Preset (PN6; Kowa) AcrySof (SN6CWS; Alcon) KS-Xs (STAAR ; Japan) Eternity (MXJ-60; Santen) Force (N) 25 20 15 10 5 0 0 5 10 15 20 25 Adapted from Usui M et al. 2013. Time (sec) 06 07
PRECISION ENSURES RESULTS Controlled lens unfolding Stable within capsular bag AvanseePreset s original design facilitates controlled lens unfolding after insertion, ensuring shape recovery and optical quality restoration. Its low, consistent delivery force and soft, flexible haptics minimise damage and deformation during insertion and unfolding 2,3 The optimal water content of Avansee suggests good flexibility 3,4 The water content of Avansee is 2.0% Avansee does not cause zonal stress or transformation of the capsular bag, and its soft, flexible haptics with a large contact area are unlikely to damage the eye 5 Aberration-neutral Avansee retains the spherical aberration (SA) of the eye, and is therefore less affected in conditions of decentration or tilt compared to IOLs with a greater SA corrective power (aspherity of Avansee is -0.04μm) 6 08 09
Glistening-free Low PCO rate There have been no reports of glistening with Avansee since launch in 2007. 7,8 In a four-year observational study, no glistening was reported with Avansee, whilst both AcrySof and AF-1 were associated with some degree of glistening in the majority of patients 9 Avansee has a smooth lens surface and square-edged platform that is associated with a low incidence of posterior capsule opacification (PCO). In a retrospective study in 4,862 eyes, the proportion of PCO cases requiring Nd:YAG treatment after two years was significantly lower in patients receiving Avansee or AcrySof than in those receiving the rounder-edged Hoya IOL (p<0.0001 for both comparisons) 10 Glistening reported with IOLs 9 Company Model Number of cases Number of cases requiring Nd:YAG Percent of eyes (%) 0 50 100 Avansee, Kowa n=49 (87 eyes) Kowa Avansee Preset AN6, AN6K, AN6M, AN6MK 2,206 38 (1.7%)* AcrySof (Alcon) n=17 (21 eyes) AF-1 (Hoya) n=12 (22 eyes) Alcon AcrySof SA60AT, SN60AT, SN60WF 1,604 39 (2.4%)* No glistening Mild 50/mm 3 Moderate 100/mm 3 Serious 200/mm 3 Hoya YA-60BBR 1,052 76 (7.2%) Adapted from data provided by I Ota. Adapted from data provided by K Miyake. 10 Whilst Avansee has a water content of 2.0% allowing for flexibility, 4 the cast-moulded optics of Avansee are made from a stable, uniform and highly cross-linked polymer, preventing water from gathering in microvoids of the material and thereby eliminating glistening *p<0.0001 versus Hoya. 11
Proven long-term safety The number of adverse events reported with Avansee is low. 8 Over half a million Avansee lenses sold since launch in 2007 to March 2014 with 22 reports of adverse events (0.003%) and 2 reports of serious adverse events (0.0003%) 500,000+ Avansee lenses sold between March 2007 to March 2014 22 reports of adverse events 12
A fully preloaded IOL system delivering confidence through controlled precision Allowing preparation for IOL insertion in 2 simple steps Safe and efficient insertion of a foldable aspheric hydrophobic IOL Providing reliable, reproducible and controlled lens insertion through an original IOL system design Low, consistent and homogeneous force requirement enables smooth and controlled insertion with just one hand 2 Offering optimal visual acuity with minimal post-operative complications Controlled unfolding with stability after insertion 2-5 Aberration-neutral, glistening-free, low PCO rates 6-10 Proven long-term safety 8 www.avansee.eu www.kowapharmaceuticals.eu 1. Avansee Preset PI. 2014. 2. Usui M et al. Abstract presented at the American Society of Cataract and Refractive Surgery; 2013; April 19-23; San Francisco, California, USA. 3. Bozukova D et al. J Cataract Refract Surg 2013; 39: 1404-1414. 4. Kawai K et al. Tokai J Exp Clin Med 2012; 37: 62-65. 5. Data provided by I. Ota. Stability data. 6. Fujikado T and Saika M. Journal of the Eye 2014; 31: 123-132. 7. Data on file. Complaints. Kowa Co., Ltd. 8. Data on file. Adverse events. Kowa Co., Ltd. 9. Data provided by I Ota. Glistening data. 10. Data provided by K Miyake. PCO data. Date of preparation: September 2014 IOL14 00028a