Individual Eye Tumor Treatment with COMS Eye Applicators
Eckert & Ziegler BEBIG’sOphthalmic Seed is an IsoSeed® I-125 (I25.S16) with a particularly high activity for eye tumortreatments.
COMS Eye Applicators provided by Eckert & Ziegler BEBIG offerexact seed positioning and accurate dose distribution.
Indication
IsoSeed® I25.S16 is used for the treatment of eye tumors, such as uveal melanomas andretinoblastomas. With apparent activities covering a wide range up to 25 mCi, it is even suitable for treating medium-sized to large eye tumors, opening up treatment options beyond Ru-106 Eye Applicators.
Application
IsoSeeds I25.S16 are delivered non-sterile. For application, they can be inserted via silicone inserts into COMS Plaque Shells, both available from Eckert & Ziegler BEBIG. After steamsterilization, the individually assembled COMS Applicator is ready for use. With IsoSeed®I25.S16, treatment planning is carried out based on the seed data of IsoSeed® I25.S06 according to the AAPM TG-43 formalism.
COMS Eye Applicator
COMS Eye Applicators were developed following the plaque therapy used in the Collaborative Ocular Melanoma Study. They are available in 5 different sizes, between 12 - 20 mm in diameter. For the treatment, the reusable gold COMS Plaque Shell is combined with a single-use silicone COMS Insert, individually loaded with IsoSeeds. The number of seeds needed for an implant depends on the size of the applicator and the respective loading scheme (see rear page for more details on slot positions). In order to fix the insert securely in the plaque shell, a few droplets of adhesive silicone are placed on the inner rim of the shell. After subsequent steam sterilization, the applicator is ready for implantation.
Calibration
The certified source strength is based on air kerma measurements of IsoSeed® which are traceable to the primary standard of the PTB (Physikalisch-Technische Bundesanstalt = National Metrology Institute of Germany). Along with the NIST (National Institute of Standards and Technology), the PTB is a member of the Mutual Recognition Agreement.
Guaranteed Biocompatibility
The titanium capsule of IsoSeed® I25.S16 meets ASTM F67 requirements, and COMS Plaque Shells are also tested according to international standards. Silicone COMS Inserts are made from Silastic® MDX4-4210 BioMedical Grade Elastomer. These features ensure overallbiocompatibility of both Eckert & Ziegler BEBIG Ophthalmic Seeds and COMS Eye Applicators.
"Made in Germany" Quality
Our Ophthalmic Seeds and COMS Eye Applicators are manufactured in Germany in compliance with strict quality standards. Each single item has to pass an individual quality check at every production stage before proceeding to the next step. Eckert & Ziegler BEBIG is certified in accordance with ISO 13485.
