ILM-Blue from DORC Receives NMPA Approval in China; Expanding Global Reach
ZEISS Medical Technology announced that ILM-Blue® from DORC has received NMPA approval in China, expanding its global reach. The product, used for staining and distinguishing the inner limiting membrane during vitreoretinal surgery, has been utilized in over 900,000 procedures worldwide since 2010.
ILM-Blue® is the first DORC posterior dye product available in China and remains the only ILM staining solution approved by the FDA. In the U.S., where it's marketed as TissueBlue®, it's ranked as the #1 preferred ILM stain among retina surgeons. The product helps facilitate membrane removal and reduces the risk of retinal damage during surgery.
ZEISS Medical Technology ha annunciato che ILM-Blue® di DORC ha ricevuto l'approvazione NMPA in Cina, ampliando la sua portata globale. Il prodotto, utilizzato per colorare e distinguere la membrana limitante interna durante la chirurgia vitreoretinica, è stato impiegato in oltre 900.000 procedure in tutto il mondo dal 2010.
ILM-Blue® è il primo prodotto di colorazione posteriore DORC disponibile in Cina ed è l'unica soluzione di colorazione ILM approvata dalla FDA. Negli Stati Uniti, dove è commercializzato come TissueBlue®, è classificato come il colorante ILM preferito numero 1 tra i chirurghi retinici. Il prodotto aiuta a facilitare la rimozione della membrana e riduce il rischio di danni retinici durante l'intervento chirurgico.
ZEISS Medical Technology anunció que ILM-Blue® de DORC ha recibido la aprobación NMPA en China, ampliando su alcance global. El producto, utilizado para teñir y distinguir la membrana limitante interna durante la cirugía vitreorretiniana, ha sido utilizado en más de 900,000 procedimientos en todo el mundo desde 2010.
ILM-Blue® es el primer producto de tinte posterior de DORC disponible en China y sigue siendo la única solución de tinción ILM aprobada por la FDA. En los EE. UU., donde se comercializa como TissueBlue®, ocupa el primer lugar como el tinte ILM preferido entre los cirujanos de retina. El producto ayuda a facilitar la extracción de la membrana y reduce el riesgo de daño retinal durante la cirugía.
ZEISS Medical Technology는 DORC의 ILM-Blue®가 중국에서 NMPA 승인을 받았다고 발표하며, 글로벌 범위를 확장하고 있습니다. 이 제품은 유리체망막 수술 중 내한계막을 염색하고 구별하는 데 사용되며, 2010년 이후 전 세계에서 900,000건 이상의 절차에 사용되었습니다.
ILM-Blue®는 중국에서 사용할 수 있는 DORC의 첫 번째 후면 염료 제품이며, FDA의 승인을 받은 유일한 ILM 염색 용액입니다. 미국에서는 TissueBlue®라는 이름으로 판매되며, 망막 외과의사들 사이에서 가장 선호되는 ILM 염색제로 평가받고 있습니다. 이 제품은 막 제거를 용이하게 하고 수술 중 망막 손상의 위험을 줄이는 데 도움을 줍니다.
ZEISS Medical Technology a annoncé que ILM-Blue® de DORC a reçu l'approbation NMPA en Chine, élargissant ainsi sa portée mondiale. Le produit, utilisé pour teindre et distinguer la membrane limitante interne lors de la chirurgie vitréo-rétinienne, a été utilisé dans plus de 900 000 procédures dans le monde depuis 2010.
ILM-Blue® est le premier produit de teinture postérieure de DORC disponible en Chine et reste la seule solution de teinture ILM approuvée par la FDA. Aux États-Unis, où il est commercialisé sous le nom de TissueBlue®, il est classé comme la teinture ILM préférée numéro 1 parmi les chirurgiens de la rétine. Le produit facilite l'élimination de la membrane et réduit le risque de dommages rétiniens pendant la chirurgie.
ZEISS Medical Technology hat angekündigt, dass ILM-Blue® von DORC die NMPA-Zulassung in China erhalten hat, was die globale Reichweite erweitert. Das Produkt, das zur Färbung und Unterscheidung der inneren Grenzmembran während der vitreoretinalen Chirurgie verwendet wird, wurde seit 2010 in über 900.000 Verfahren weltweit eingesetzt.
ILM-Blue® ist das erste DORC-Hintergrundfarbprodukt, das in China erhältlich ist, und bleibt die einzige von der FDA genehmigte ILM-Färbelösung. In den USA, wo es als TissueBlue® vermarktet wird, ist es das am meisten bevorzugte ILM-Färbemittel unter den Netzhautchirurgen. Das Produkt hilft, die Entfernung der Membran zu erleichtern und das Risiko von Netzhautschäden während der Operation zu verringern.
- First DORC posterior dye product approved in China, opening new market opportunities
- Only FDA-approved ILM staining solution in the US market
- #1 preferred ILM stain among US retina surgeons
- Proven track record with 900,000+ procedures worldwide since 2010
- None.
JENA,
"ZEISS and DORC are committed to supporting surgeons in the
"We are delighted to bring ILM-Blue to the Chinese market, where it will provide retina surgeons with a proven, high-quality staining solution to enhance visualization," says Jessie Jiang Bo, General Manager of DORC in
ILM-Blue® is used to clearly stain and easily distinguish the inner limiting membrane (ILM) from underlying retinal layers during vitreoretinal surgery. This facilitates membrane removal and reduces the risk of retinal damage1. Since its launch in 2010, ILM-Blue® from DORC has been used in more than 900,000 procedures worldwide2, consistently supporting vitreoretinal surgeons to improve patient outcomes and setting new standards in posterior segment surgery. With this latest approval, ILM-Blue® becomes the first DORC posterior dye product available in
To date, ILM-Blue® remains the only ILM staining solution approved by the FDA. It is marketed under the brand name TissueBlue® in the
1 Instructions for use.
2 DORC data on file.
3 Figueroa M.S. et al; Long-term outcomes of 23-gauge pars plana vitrectomy with Internal Limiting Membrane peeling and gas tamponade for myopic traction maculopathy, retina: September 2015 - volume 35 - issue 9 - p 1836-1843 doi: 10.1097/iae.0000000000000554.
4 Veckeneer, M., Mohr, A., Alharthi, E., Azad, R., Bashshur, Z. F., Bertelli, E., ... & Melles, G. R. (2014). Novel 'heavy'dyes for retinal membrane staining during macular surgery: multicenter clinical assessment. Acta Ophthalmologica, 92(4), 339-344.
5 2023 survey of US retinal Surgeons, ASRS meeting,
Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country-specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development. The statements of the healthcare professionals reflect only their personal opinions and experiences and do not necessarily reflect the opinion of any institution that they are affiliated with. The healthcare professionals alone are responsible for the content of their experience reported and any potential resulting infringements. Carl Zeiss Meditec AG and its affiliates do not have clinical evidence supporting the opinions and statements of the healthcare professionals nor accept any responsibility or liability of the healthcare professionals' content. The healthcare professionals have a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and have received financial support.
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Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on the MDAX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With 5,730 employees worldwide, the Group generated revenue of
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About D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
D.O.R.C. is one of the world's leading suppliers of equipment, instruments and liquids for ophthalmic surgery. For over 40 years, D.O.R.C. has grown into a successful international business, shaping its product portfolio through close collaboration with leading top surgeons. The company improves eye surgery globally and maximizes surgeon control by providing innovative quality approaches for eye disorders. Its products are exported to more than 80 countries worldwide. The company is headquartered in Zuidland,
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