Nidek Launches NP-T Preloaded Toric IOL Injector System Globally Following CE Mark Approval

Dec 20, 2024 10:02 CST Updated 10:02

NIDEK

Ophthalmic Surgical Instrument Diagnostic Equipment Developer

Source of the article: Eye Future ；Editor: Sophia

Reprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.

Global Ophthalmology Conference Registration

Award Registration! Rare Opportunity! Global Ophthalmology Innovation Series Awards GOC Awards 2025

Recently,Nidek（Nidek）Announced itsNP-T Preloaded Toric IOL (Intraocular Lens) Injector SystemLaunched internationally, the system was previously only sold in Japan,It has now expanded to the global market., marking a further development of NIDEK in the field of ophthalmic surgical instruments.

In June 2024, itsNP-1/NP-1C Preloaded IOL Injector System Receives CE MarkThe system comes pre-installed with the Aktis aspheric hydrophobic soft acrylic lens, which has a diopter range from 1.0 to 30.0.The syringe adopts a simple two-step process: filling the viscoelastic agent and pressing the plunger.NP-1/NP-1C has been previously launched in Japan and other regions of Asia.

Traditional Non-Preloaded Intraocular LensBefore implantation, it is necessary to go through steps such as unpacking and removing the intraocular lens, injecting viscoelastic agent into the inserter tip, accurately placing the intraocular lens into the inserter tip, and assembling the inserter tip with the injector.Not only is the process complicated, but it also increases the risk of errors, damage, and contamination during the loading of intraocular lenses.。

Preloaded Intraocular Lens SystemBy preloading the intraocular lens into the injector,Simplified the surgical procedure andLoading Error, avoiding damage, optical surface injury, or scratches to the intraocular lens caused by loading actions; meanwhile, throughout the entire surgical procedure, it maximizes the isolation of the intraocular lens from external contact, reducing the risk of infection and inflammation caused by contamination of the intraocular lens.Improved surgical safety。

# NP-T Preloaded IOL InjectorSystem

Nidek's NP-T Injection System is equipped withAspheric Hydrophobic Soft Acrylic Toric Lens, this design offers excellent maneuverability and reliable in-the-bag fixation.

First, fill with viscoelastic material, then press the plunger for quick and easy operation.
Design of Double Silicone RingsMinimizes sudden changes in resistance during injection to the greatest extent., thereby achieving stable, continuous, and safe intraocular lens delivery.
Optimized length and 90° tactile design (referred to as the anchor wing loop)Increased contact area with the capsule, which helps achieve stable and centered IOL implantation.

Studies show that Nidek's Toric IOL within 1 hour to 6 months after surgeryExhibiting very high stability, with an average absolute rotation of only 2.1°±1.7°.

This means that even after a longer period post-surgery, the IOL can maintain a good position and orientation, ensuring the effectiveness of astigmatism correction.。

# Product Market Overview

In recent years, with the development of refractive cataract surgery, the intraocular lens injection system has also been continuously improved. Initially, foldable intraocular lenses were implanted using forceps to fold them, which later evolved into the form of an injector.After curling the intraocular lens, it is injected into the eye through various injectors to achieve the goal of small-incision cataract surgery.。

With the clinical application of the preloaded intraocular lens injection system, it brings broader development prospects for refractive cataract surgery.

The rapid expansion of China's intraocular lens market is rooted in the large population of cataract patients. Cataracts are the leading cause of blindness and a common condition among middle-aged and elderly people.According to statistics from the Ophthalmology Branch of the Chinese Medical Association, the incidence rate of cataracts in people aged 60 and above in China is approximately80%, according to this estimate, the number of cataract patients in China may have reached as high as208 million(According to the data from the seventh national census in China, there are 260 million people aged 60 and above in China).

According to Frost & Sullivan forecasts, the size of China's intraocular lens market in 20214.2 billion yuan, Predicted for 20309.8 billion yuan。According to Frost & Sullivan, the number of cataract surgeries in China is expected to increase from 4.3 million in 2019 to11.4 million cases, with a compound annual growth rate of9.3%。

The preloaded intraocular lens injection system has the following advantages during the surgical operation process.：

Streamline the operation process and reduce the risk of infection
During the surgical procedure, doctors are no longer needed.Or an assistant to help load the intraocular lens, and from the moment the packaging is opened until the lens is implanted into the eye, the intraocular lens does not come into contact with other parts of the surgical field or other surgical instruments, further reducing the risk of intraoperative contamination.
A retrospective study in Europe, lasting 8 years and involving more than 20,000 cases of intraocular lens implantation, showed that,The incidence of postoperative endophthalmitis with non-preloaded intraocular lenses is more than 10 times that of preloaded intraocular lenses.Therefore, the use of preloaded intraocular lenses can better achieve the goal of reducing cataract-related endophthalmitis.
Consistent folding morphology to avoid intraocular lens damage
Preloaded intraocular lens injector canMaximally ensure that the intraocular lens remains in an ideal folded state during implantation.。
The folding state of intraocular lenses significantly impacts their structure and function. If the folding state is not ideal, it may not only result in difficulties implanting the lens or cause creases but also lead to potential damage or surface scratches during the injection process due to suboptimal relative positioning between the intraocular lens and the plunger or friction with the injector. Such issues can affect the lens's optical performance and consequently impact the visual quality after refractive cataract surgery.

Currently, more than 20 preloaded intraocular lens injection systems have been approved for marketing in China, including imported brands such asHoya, Alcon, Johnson & Johnson, Luneau, etc. Among themThere are 8 approved preloaded intraocular lens systems made in China, includingAibornode, Leiming Vision Care, Eyelightetc.

Part of the approved imported preloaded intraocular lens systems

Approved Preloaded Intraocular Lens System Manufactured in China

AlconUltraSert Preloaded IOL Injector SystemBreakthrough improvements have been made to the design of the injection head, compatible with a 2.2mm minimally invasive incision; the DepthGuard protection device at the front end., which can control the depth of the injection head entering the eye, preventing the injector from being inserted too deeply into the anterior chamber and damaging intraocular tissues, assisting ophthalmologists in performing surgeries more efficiently, smoothly, and quickly. Tension Glide Pressure-relief Type InjectorCan ensure that the intraocular lens maintains a stable and smooth speed throughout the injection process.To prevent the situation where the intraocular lens is rapidly ejected, resulting in failure to inject in one push or causing damage to other tissues.

UltraSert Preloaded IOL Injector System

Aibono'sILIS^®Disposable Intraocular Lens Implantation SystemYesThe World's Only "Screw-in" Disposable Intraocular Lens Implantation System (As of December 4, 2024), reducing the risk of puncturing the posterior capsule; flat insertion head design eliminates lens creases; proprietary pushrod tip design prevents posterior haptic clamping; suitable for injecting various material types, different haptic designs of intraocular lenses, and cataract surgeries with different incisions, meeting the needs of 1.8/2.2/2.8mm incisions.

ILIS® Disposable Intraocular Lens Implantation System

Shuochuang (Shanghai) Medical Device Co., Ltd.Self-developedTwitter^®Disposable Sterile Intraocular Lens Injector, successfully obtained the medical device registration certificate in January 2024 (Registration Certificate No.: Hu Medical Device Registration Approval 20242160032).The product has a built-in track design. After injecting the viscoelastic agent,Insert the intraocular lens in an inverted "S" direction., Press the two wings of the insertion head, fold the intraocular lens, assemble the insertion head onto the injector, then inject the intraocular lens and wait for it to unfold.

Twitter® Single-Use Sterile Intraocular Lens Injector

# About NIDEK

NIDEK CO., LTD. was established in 1971 and is headquartered in Gamagori City, Aichi Prefecture, Japan. Driven by the research and development of optical and electronic technologies, NIDEKOphthalmology, Eyewear, CoatingThese three core areas expand the business scope to all over the world.

NIDEK'sOphthalmology BusinessOffering a full range of ophthalmic products from the cornea to the choroid., providing solutions from diagnosis to treatment for refractive correction, cataracts, fundus diseases, glaucoma and other eye conditions, and integrating all examination and treatment data into the NAVIS platform, thereby enabling comprehensive diagnosis and treatment as well as patient case management.

The company's ophthalmology and optometry business includesOphthalmic surgical instruments, examination and diagnostic instruments, Electronic Medical Record/Medical Archive System,Intraocular LensAnd the design, development, manufacturing, and sales of dermatological surgical lasers, as well asOptometry Instruments, Eyeglass Lenses, optical components, filter coatings sales and import/export.

# Global Leading Ophthalmic Device and Consumables Company

# Chinese Ophthalmic Devices and Consumables Companies

# Chinese Ophthalmology Medical Service Company

# Overseas Ophthalmology Startups