Kelin Instruments Receives Approval for SMART Phaco-Vitrectomy System Launch in China

Dec 09, 2024 14:24 CST Updated 14:24

CLINICO INSTRUMENT

Ophthalmic Instrument Manufacturer

Source of the article: Eye Future ；Editor: Sophia

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Recently,CLINICO INSTRUMENT CO., LIMITEDTheSMART Phacoemulsification and Vitrectomy Integrated MachineApproved for marketing in China, this ophthalmic surgical equipment combines efficiency, stability, and innovation.About to officially enter the Chinese market, bringing new treatment options to a wide range of ophthalmic patients.

The Phacoemulsification and Vitrectomy Integrated Machine is a high-precision, multi-functional ophthalmic surgical device that combinesVitrectomy and Cataract PhacoemulsificationTwo major functions, mainly used for the treatment of vitreous and cataract-related diseases. The device utilizes minimally invasive technology,Using ultrasonic energy to emulsify and aspirate the cataract lens, while performing vitrectomy., effectively reducing surgical trauma and patients' postoperative recovery time,Has become an important tool in modern ophthalmic surgery, widely applied inHospitals, outpatient surgery centers and other medical institutions.

However, the technical barriers of the vitrectomy system in the phaco-vitrectomy integrated machine are relatively high,No domestically produced phacoemulsification and vitrectomy integrated machine has been approved for marketing in China.. In recent yearsCome on, the R&D investment of Chinese companies in vitrectomy systems continues to increase. Since the phacoemulsification system is relatively simpler than the vitrectomy system, many hospitals also configure a separate phacoemulsification system (referred to as "single phaco").Three ultrasound emulsifiers produced in China have been approved for marketing.。

SMART Phacoemulsification and Vitrectomy Integrated Machine

# SMART Phacoemulsification and Vitrectomy Integrated Machine

The SMART Phacoemulsification and Vitrectomy Integrated System is an ophthalmic surgical system that combines efficiency, stability, and multifunctionality. Built on the advanced technology of BVI Company, it aims to meet the growing demands of ophthalmic surgery through continuous software and hardware upgrades.

Product Key Features and Functions

Agile Fluidics™ Technology

Agile Fluidics™ Technology is an advanced patented software algorithm capable of intelligently and proactively responding to negative pressure generated and measured during surgical procedures. This technology monitors negative pressure changes in real time and adjusts accordingly based on these variations.Instantly adjust perfusion pressure to maintain a stable intraocular pressure (IOP).。

Minimal Stress™ Technology

The technologyUsing Feedback Control Mechanisms to Manage Energy Transfer to Piezoelectric Crystals, ensuring consistency between the program settings and the actual ultrasound tip travel.Even in hard-core patients (referring to patients with harder cataract nuclei), the Minimal Stress™ technology ensures efficient energy transfer, which is crucial for the success of the surgery.

By optimizing energy transmission, Minimal Stress™ technologyReduced the potential damage to intraocular tissues, including the loss of endothelial cells and the risk of thermal burns, surgical efficiency is improved.

TWEDGE™10K Dual-Blade Vitrectomy

TWEDGE™10K Dual-Blade Vitrectomy System through itsHigh cutting frequency, high opening-closing ratio, double-edged design, and high-strength material, which breaks through the limitations of traditional single-edge vitrectomy heads, can remove the vitreous more effectively and reduce traction on the retina. It is especially suitable for complex retinal surgeries.

TWEDGE™10K Dual-Blade VitrectomyOffers a cutting frequency of up to 10,000 CPM (cuts per minute) with an opening and closing ratio of up to 98%., which means that the proportion of opening and closing of the vitrectomy probe during each cutting cycle is very high, thereby increasing the rate of vitrectomy and aspiration.Available in two minimally invasive specifications: 23G and 25G.，Significantly reduce disturbances, greatly decrease the occurrence of iatrogenic holes in patients with retinal detachment, and improve the safety of the surgery.

Dual LED Light Source

With less phototoxicity and longer light source lifespanEquipped with two independent high-efficiency LED light sources, effectively avoiding harmful ultraviolet and infrared rays. Four optional filter lenses provide additional retinal protection and enhance tissue visualization.

Dual Pump Design

Adopted a dual-pump design with a peristaltic pump + Venturi pump，Peristaltic pumps are known for their precise flow rate control and repeatability, making them suitable for surgeries that require exact perfusion fluid flow. Venturi pumps, on the other hand, are renowned for their high efficiency and self-priming capability, making them ideal for surgical environments that demand rapid suction.

In additionIntroduction of EasySys Fluid System, with a dual-pump design, enables the SMART phacoemulsification and vitrectomy integrated machine to adapt to cataract surgery as well as complex retinal surgeries.Reduce surge and provide better liquid flow control, improve surgical efficiency and stability.

# Phacoemulsification and Vitrectomy Integrated Machine Market

TheIn ophthalmic treatments, the phacoemulsification and vitrectomy integrated machine is mainly used in two major types of surgeries:Fundus Surgery and Cataract Surgery。

If the vitreous is not removed first during fundus surgery, a coexistence of water and vitreous inside the eyeball will form post-operation, which may instead cause retinal damage, soVitrectomy is basically required for all ocular fundus surgeries., it is necessary to use vitrectomy equipment.

Cataracts are currently mainly treated through surgery. The commonly used international statistical indicator for cataract surgeries is CSR (the annual number of cataract surgeries per million people), which exceeds 10,000 in developed countries, while in China it has only recently surpassed 3,000.Huge Demand for Cataract Surgery in China。Phacoemulsification causes minimal corneal damage in cataract patients and allows for rapid postoperative visual function recovery.Although the introduction of femtosecond laser has further improved the precision of cataract surgery,The phacoemulsification and vitrectomy integrated machine is still a very commonly used device in ophthalmology., playing an indispensable role in fundus surgery and cataract surgery.

According to the statistics and forecast by QYR (Hengzhou Bozhi),Global Sales of Vitrectomy Phacoemulsification Integrated Machines Reached US$214 Million in 2023 and are Expected to Reach US$366 Million by 2030, with a compound annual growth rate (CAGR) of 7.6% (2024-2030).

Global Core Manufacturers of Vitrectomy Phacoemulsification Integrated Machines IncludeAlcon, Bausch + Lomb, and German Goetheetc.,The top three manufacturers account for approximately 87% of the global market share.At present, Alcon is the world's largest producer of integrated vitrectomy and phacoemulsification machines, holding more than 48% of the market share. North America, Europe, and the Asia-Pacific region are the main global markets for these machines, collectively accounting for over 92% of the market share.Asia-Pacific is the largest market, accounting for 38% of the share.In terms of product types, the dual-pump type is the largest segment, with a market share exceeding 59%. In terms of applications, hospitals are the largest downstream sector, accounting for approximately 57% of the market share.

According to Frost & Sullivan analysis,China's vitrectomy volume exceeded 400,000 cases in 2023, with over 400 phacoemulsification-vitrectomy integrated machines installed., of which the publicly accessible winning bid data for public hospitals is 65 units.。

According to the publicly available中标data from Chinese public hospitals,Alcon's Constellation series has the highest total sales market share, reaching 47.9%., occupying a dominant position in the market; Bausch + Lomb ranks second, with a sales market share of 29.6%; Geuder ranks third, with a sales market share of 16.1%; OPHTEC ranks fourth, with a sales market share of 6.4%.

Currently, all-in-one phacoemulsification and vitrectomy machines in China are imported brands, with an average unit price close to。The average price of ODI products is 1.304 million yuan, ranking first among the average prices of中标products.; The average price of Alcon products is 1.249 million yuan, ranking second; the average price of Bausch + Lomb's series of winning-bid products is 1.216 million yuan, ranking third; the average price of Geuder's series of winning-bid products is 1.009 million yuan, ranking fourth.

Chinese high-end ophthalmic medical device companies are also entering the field of developing phacoemulsification and vitrectomy integrated machines.XIRAN MedicalUpcoming Phacoemulsification and Vitrectomy Integrated Machine, is the only domestically developed original in China, and has been granted multiple invention and utility model patents; currently undergoing type inspection at national testing institutions.It is estimated that animal and clinical trials will be conducted in the fourth quarter of this year.。Tupai Medical's All-in-One Phacoemulsification and Vitrectomy Machine "Vanguard"It is expected to start type inspection and registration work in 2025.。In addition, there are several companies in China engaged in the research, development, and production of vitrectomy probes and other consumables.

Genesis Product Rendering by Xiran Medical

September 2024,Jia Shi NuodeDeveloped bySingle-Use Vitrectomy Head Receives Market Approval from China's National Medical Products Administration (NMPA), this isThe First Product in ChinaThe domestically developed Chinese-made vitrectomy probe, which is also the world's second dual-pneumatic vitrectomy probe with a base cutting speed of 10,000 times per minute, marks that China has reached an internationally advanced level in the field of vitrectomy surgical medical devices, breaking the monopoly of domestic oligopolies.

Gastroduo Dual-Airflow High-Speed Vitrectomy Probe

The phacoemulsification and vitrectomy integrated machine is continuously evolving towards the field of minimally invasive surgery. The diameter of the cutting head used in the equipment has evolved from 20G (0.9 mm in diameter) to 27G (0.4 mm in diameter). At the same time, it is becoming more intelligent, high-speed, and safer.Has also become an important direction for the research and development of phacoemulsification and vitrectomy integrated machines.

Due to the ongoing空白状态 in China, there is significant potential for the国产替代 of phacoemulsification and vitrectomy machines in the future.The high prices of imported vitrectomy equipment and consumables pose significant challenges to the popularization of vitrectomy surgeries. In the next three years, with the launch of more cost-effective products from companies like Xiran and Tupai, the industry is expected to embrace new opportunities for domestic production and incremental development space. Especially,If the vitrectomy probe and vitrectomy surgical kits achieve full domestic production in China, the cost of vitrectomy will be significantly reduced, and the number of surgeries will also increase considerably.。Under the future trend of medical insurance DRG payment, it is imperative to reduce the cost of vitrectomy surgery, and domestically produced phacoemulsification-vitrectomy integrated machines will usher in a significant period of opportunity.

# About CLINICO INSTRUMENT

CLINICO INSTRUMENT CO., LIMITED was founded in Taiwan in 1986.More than 200 offices and service points have been established both in China and overseas, forming a comprehensive system network to provide high-quality product services to customers in various regions. It has successfully promoted phacoemulsification surgery, vitrectomy, semiconductor laser technology, and more.

In 1999, the company was certified by world authoritative bodies and became an ophthalmic agency company that passed the ISO9001 certification. Subsequently, it also passed the ISO13485 Medical Device Quality Management System and the SGS Qualicert International Service Quality Certification. It was also reviewed by the American professional market analysis magazine *Market Scope* as "CLINICO INSTRUMENT CO., LIMITED is a channel partner for American ophthalmic instrument manufacturers to develop in the China region and is currently one of the distributors of ophthalmic instruments in the China region."

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