Source: Eye Future; Editor: SophiaReprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.Recently,Shanghai Jieshi Medical Technology Co., Ltd.Announced that its independently developedOphthalmic Perfluoropropane GasSuccessfully obtained the certification issued by the National Medical Products AdministrationClass III Medical Device Registration Certificate(Registration Certificate No.: China Medical Device Registration Approval 20253160327).
The ophthalmic perfluoropropane gas approved this time asChina's First Ophthalmic Specialty Gas, mainly used forRetinal Fill Treatment After Ophthalmic Surgery, whose successful launch has ended the long-standing situation in China where no domestically produced long-acting gas for retinal surgery was available, and it is also currentlyOnlyObtained registration approval in ChinaDisposable Ophthalmic Long-Acting Gas。
Before this perfluoropropane gas for ophthalmic use was approved, only two imported companies, Alcon and Arkhemia, had their long-acting gases for ophthalmic use approved in China (their registration certificates have expired and are in the process of renewal), and neither product is for single use.Import monopolies and the risk of infection from repeated use largely limit the application of long-acting gases for ophthalmic use., Jieshi Medical perfluoropropane gas for ophthalmic use, as a disposable long-acting gas for ophthalmic use, has greater advantages.
This product is mainly used as an intraocular filling gas material, which can reposition and heal detached retinas. Through multi-center, randomized controlled clinical trials, this long-acting perfluoropropane gas for ophthalmic use...Efficacy and safety are non-inferior to mainstream imported products on the market.。
# Research and Development BackgroundRetinal detachment is a serious blinding eye disease that requires surgical repositioning. Traditional methods such as scleral buckling and vitrectomy, while effective, have issues such as significant trauma and slow recovery.Intraocular fillers play a crucial role in surgery. Traditional gases such as air and sulfur hexafluoride (SF6) are absorbed quickly and require patients to maintain a specific position for a long time, impacting their quality of life.ForTo Reduce Patient Inconvenience and Improve Treatment Outcomes, the Development of Long-Acting Gases Becomes a Trend。
Perfluoropropane (C3F8), as a long-acting gas, has been used in vitreous surgery for 40 years. In 1980, Lincoff and Chang selected two fluorocarbon gases, C2F6 (perfluoroethane) and C3F8 (perfluoropropane), for clinical use based on animal studies.Due to its longer filling duration, C3F8 is more widely used than C2F6.。
The principle of C3F8 as an intraocular filler includesMaintain intraocular pressure, seal the裂孔, and reposition the detached retina.。Utilize the physical property of long-acting gas with a high expansion coefficient to pressurize the repositioned retina, promoting healing after retinal reattachment. The gas exhibits significant surface tension, which can seal retinal breaks, prevent vitreous cavity fluid from flowing through the break to the subretinal space, eliminate the fish-mouth phenomenon in horseshoe tears, and flatten retinal folds as well as the rolled flaps of giant retinal breaks.
The physical properties of C3F8 are characterized by expansibility.Absorbing gases (N2, O2, CO2) from surrounding tissues to increase volume, achieving a "long-lasting" effect., The retention time in the eye is related to the concentration and volume of the injected gas.
From a clinical perspective,C3F8 can remain in the eye for several weeks to months., reducing the need for patients to frequently adjust their position, improving postoperative quality of life; providing a more stable buckling effect, reducing recurrence rates; chemically stable, good biocompatibility, reducing the risk of postoperative inflammation and infection; no secondary surgery required for removal, reducing the workload of doctors.
# Jieshi® Perfluoropropane Gas for Ophthalmology【Product Name】Ophthalmic Perfluoropropane Gas【Product Specifications】30mL per bottle【Main Ingredients】Perfluoropropane, purity higher than 99%.【Chemical Structure】CF3-CF2-CF3；Molecular Formula: C3F8; Molecular Weight: 188【Product Properties】Colorless and transparent gas.【Product Performance】Chemically stable, a colorless and transparent gas,Can be used for intravitreal injection and gradually excreted through the blood and respiratory system after injection.。【Scope of Application】This product is an ophthalmic surgical aid and can be used for intraocular filling in vitreoretinal surgery.The selection of patients and the choice of surgical procedures are determined by ophthalmologists.Jieshi®Ophthalmic Perfluoropropane Gas AdoptedBinary PackagingThe form can prevent the external environment from contaminating the product. The inner bag valve is composed of multi-layer aluminum foil and polymer composite materials, offering excellent biological safety.Instructions for Preparation and Use
Jieshi®Ophthalmic Perfluoropropane Gas Product byA gas cylinder filled with perfluoropropane, a 50mL syringe, and a 0.22μm filter headComposition. Each sterilized packaged cylinder is filled with non-sterile perfluoropropane gas and must be sterilized using a sterilized filter head.Need to be prepared and used immediately。Before use, forcefully open the protective cap at the top of the gas cylinder, attach the filter head to the end of the syringe, hold the syringe, and firmly insert it into the valve at the top of the cylinder. The gas passes through the 0.22μm filter head and is released into the syringe; then retract the syringe plunger.After the gas is released, pull out the syringe, adjust the piston according to the scale on the syringe to obtain the required perfluoropropane gas, and then inhale.Air filtered through a matched 0.22μm filter headObtain the mixed gas of the required volume fraction (the recommended concentration is 14%, and the preparation method can be found in Table 1). Finally, the filter head can be removed before use (for an operation example, see the figure above).Shanghai Jieshi Medical Technology Co., Ltd.'s product line mainly focuses on the field of ophthalmic medical devices, specifically includingOphthalmic surgical consumables,Such as perfluoropropane gas for ophthalmic use, used for retinal tamponade after retinal detachment surgery to help reposition the retina;And itsOphthalmologySurgery-related consumables (such as may include intraocular fillers, viscoelastic agents, etc.).Durasil® II Ophthalmic Heavy Water
The product has been approved as a Class III medical device.Certificate (Registration No. 20203160015 for Medical Devices in China).Perfluorooctane is chemically stable and highly inert, making it unlikely to induce biological or enzymatic reactions in the body; with a specific gravity greater than water, it can serve as a tamponade during surgery.The refractive index is similar to that of water, which can maintain a good refractive medium during surgery;
High boiling point, not easy to produce vaporization during intraocular photocoagulation or intraocular electrocoagulation; insolubleIn water, the two can form an interface; with high vapor pressure, it is more volatile into a gas, metabolized by the human body, and less likely to remain as residue.
For temporary use during surgery for rhegmatogenous retinal detachment with severe PVR, diabetic retinopathy, giant retinal tear detachment, ocular trauma, intraocular foreign body removal, and other vitreoretinal diseases with consistent mechanisms.。When using, draw the perfluorooctane for ophthalmic surgery into a sterile syringe with a fine needle, and then inject it in front of the optic disc at the posterior pole.First, a liquid sphere is formed, then the needle enters the liquid sphere and perfluorooctane is slowly injected.The retina gradually reattached from the posterior pole to the periphery.The liquid between the two layers of the retina is drained through the retinal break under the filling pressure of perfluorooctane, and then laser photocoagulation is used to seal the break for healing.Silicone Oil Injection and Aspiration Kit
In 2024, the silicone oil injection and suction kit, a product from the line of consumables for the vitreoretinal surgical system developed and produced by Shanghai Jieshi Medical Technology Co., Ltd., officially passed the evaluation and approval of the Shanghai Municipal Medical Products Administration, obtaining the medical device registration certificate (Shanghai Medical Device Registration No. 20232160361).
"Silicone OilThe "Irrigation-Aspiration Set" consists of equipment connectors, tubing, connectors, filters, and syringe adapters. The tubing is made of thermoplastic polyurethane elastomer rubber material, and the filter is made of polypropylene material.Can be used in conjunction with mainstream vitrectomy ophthalmic surgery systems to assist in the infusion and aspiration of intraocular silicone oil.。- Disposable Ophthalmic Puncture System
Shanghai Jieshi Medical Technology Co., Ltd. "Disposable Ophthalmic Puncture System"3 trocars and 1 infusion tubeComposition,Used in ophthalmic surgeries such as vitrectomy to establish instrument channels at the pars plana., alreadyApproved for Class II Medical Device Registration Certificate (Shanghai Medical Device Registration Approval 20252160024).
Puncture needle, puncture cannula, and bifurcated tube are adoptedMade of stainless steelCompleted, the perfusion connector and self-closing valve are adopted.SiliconeMade of, puncture handle, protective cap, bifurcated tube seat, and perfusion joint adoptMedical-Grade PlasticMade, with a standard Luer connector for the infusion port.
Unique tetrahedral edge design reduces penetration resistance; rounded tip of the cannula minimizes wound damage; groove design allows easier handling and removal by doctors.The 3/4mm mark design at the tail of the puncture handle can help doctors measure the distance from the limbus for better positioning of surgical incisions.# About Jieshi Medical
Shanghai Jieshi Medical Technology Co., Ltd. was established in January 2013 and is located within the medical device industrial base in Zhangjiang Science City. It is a high-tech enterprise in China that focuses on the research, development, and production of Class III ophthalmic medical devices.A series of intraocular implant products are in the stages of development, registration testing, or multi-center clinical research.The company now has a 1,000 square meter GMP-compliant clean room and R&D laboratory for Class III implantable medical devices, as well as a newly built 3,200 square meter production workshop for intraocular implants and supporting facilities that were put into use at the end of 2022. The total production and R&D space exceeds 4,000 square meters, forming an annual production capacity of 1 million units (sets), which basically meets the needs of the domestic market.IfBooth/White Paper/Speech SharingIf you are interested in the above content, please feel free to contact us.Contact information is as follows:You can also contact the editor-in-chief, Zhao Qing, Alice, Jacky, Ziana and other staff members of the Siyu team directly.Ophthalmology Solutions Case
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