Terumo Launches Injection Filter Needle as Part of INFINO™ Development Program
Source: Terumo Pharmaceutical Solutions
Medical device company, Terumo, has announced the launch of its injection filter needle, marking the first step in its INFINO™ Development Program. The innovative needle design enhances safety and efficacy in hypodermic and intravitreal injections by incorporating a built-in filter to prevent the injection of particulates.
The new product has been designed for intravitreal procedures, where particulates have been known to cause complications including impaired vision, increased intraocular pressure, and endophthalmitis.
Terumo Corporation announced the global launch of the Terumo Injection Filter Needle, a first step of the INFINO™ -Development Program. Indicated for hypodermic as well as for intravitreal injections, the Injection Filter Needle features an integrated polyamide 5 micrometer mesh filter to prevent particles from being injected.
Developed to extend the options for its partners in the pharmaceutical industry working towards greater safety in injected drug delivery, particularly with respect to injection into sensitive areas such as to the vitreous humor in the eye, the Terumo Injection Filter Needle features an extra thin-walled cannula. Terumo K-Pack needles 30G with an analogous ETW-cannula show more than 4 times higher flow rate compared to regular wall alternatives.
A specific hub design – in shape and material – has been developed with the aim to enhance connection between needle and syringe. This hub carries a polymer filter, intended to retain particulate matters of intrinsic or extrinsic origin.
The new product is supplied in soft-blister packaging for aseptic presentation.
Working closely with its customers, Terumo ensures that all the verification and validation activities required for the specific intended use - hypodermic and intravitreal injections, are in place. In doing so, its customers can leverage the benefits of the Injection Filter Needle to offer a complete solution for such applications, when combined with a similarly validated syringe.
“With the number of intravitreal injections increasing due to the growing prevalence of eye diseases such as neovascular age-related macular degeneration, diabetic retinopathy and diabetic macular edema, and retinal vein occlusion*1, Terumo engaged its capabilities to provide an alternative to the less-than-ideal but commonplace use of 'off label' hypodermic needles for intravitreal injection, a practice evidenced by recent field safety notices," said Marco Chiado Piat, President of Pharmaceutical Solutions Division at Terumo Europe N.V..
Thomas Isaac, Global Product Manager, Pharmaceutical Solutions Division, Terumo Europe N.V. also added “The potential presence of particulates following intravitreal procedures maybe linked with complications including impaired vision, sustained increases in intraocular pressure, and endophthalmitis, a rare but severe condition that can lead to sight loss."
The Terumo Injection Filter Needle is compliant to the ISO 80369-7 standard and has been subject to stringent and extensive testing to determine biological properties and filtration performance and to meet sterility requirements.
The new product is the first marketed product example from the INFINO™ Development project. “INFINO™ is a trademark filed by Terumo Europe N.V. for medical devices to be developed with specific features. All brand names are trademarks or registered trademarks owned by Terumo Corporation, its affiliates, or unrelated third parties.
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