OPHTHALMOLOGY INNOVATION SHOWCASE - Mynosys Cellular Devices
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Transcript of OPHTHALMOLOGY INNOVATION SHOWCASE - Mynosys Cellular Devices
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OIS-ASCRS New Orleans 2016An Ideal Capsulotomy
ZEPTOTM Innovative, disposable capsulotomy deviceNo disruption to cataract procedure or patient flowProprietary action (no cautery, thermal burning) - stronger, more extensible than femto or CCC.Minimal surgeon trainingLow cost
ZEPTOTM UNIQUE FEATURES:Capsule apposition via suction consistency in every caseZonular stabilization to address weak zonulesUse safely with small pupils (4mm)Effectively deal with corneal opacitiesUnobstructed view for centration using patient visual axis All cases general and complex
ZEPTOTM Capsulotomy SystemControl Console
Disposable Handpiece
CapsulotomyTip
Capsulotomy TipSoft, clearsuction cup
Nitinol capsulotomy ring
ZeptoTM Development
2.2 mm Latest ZeptoTM
2.2 mm
Unique Capabilities
Capsulotomy on patients visual axis using just ZeptoTM and Purkinje images
ZeptoTM posterior capsulotomy with reverse optic capture
Chamber safety -temperature2.94 secs; 1.760 C2.69 secs; 0.890C
A
BNo significant temperature change in eyeLow energy capsulotomyAdditional shielding by silicone cup
4.47 secs; 0.530C4.60 secs; 1.320C3.59 secs; 1.910 C3.69 secs; 2.010 Cduration; peak
Chang et al 2016 Ophthalmology
TEdge strength ZeptoTM vs Femto & CCC
Wilcoxon matched-pairs signed-ranks test P = 0.012Paired cadaver eyesWilcoxon matched-pairs signed-ranks test P = 0.012
ZeptoFemtosecond Laser
ZeptoCCC
Thompson et al 2016 Ophthalmology
Bottom edge ofcapsulotomy ringLens capsule at restPrecision-Pulse Capsulotomy
Suction applied, capsule pulled against ring edgeIncreased tensile stressTrapped water moleculesCross-section through device and capsule
Multipulse energy dischargesRapid phase transition ofwater moleculesCapsule membrane cleaved precisely
Apply a very quick multipulse energy discharge
Creates a rapid phase transition of the trapped water molecules
Cleaving the capsule membrane precisely
As a result, the entire 360o round capsulotomy produced instantaneously all at once11
Scanning Electron Microscopy (SEM)
ACut edgeFunctional edgeduring surgery
DCCC
BZEPTOSchematic
CZEPTO20 microns
Clinical EvaluationClinica Quesada, San Salvador, El Salvador Kevin Waltz, M.D., O.D. & Gabriel Quesada M.D.20 patients (49-85 y.o.) cataract surgery with phacoemulsification, one-piece acrylic IOL
All 20 complete free-floating ZeptoTM capsulotomies6 challenging cases : 2 with brown cataracts, 2 with small pupils, 2 with pterygiumsNo capsule related problems reported or noted out to 30 days
Regulatory Activities
CE mark approval November 2015
Single arm trial protocol with 4 weeks of follow-up submitted to FDA for 510K approval.
Market introduction
Expect to enter the European market in September of 2016
US market introduction expected late 3rd quarter to early 4th quarter 2016
OIS-ASCRS New Orleans 2016