Terumo Corporation (TSE: 4543) today 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 occlusion1, 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."2, 3
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.
To find out more about the Terumo Injection Filter Needle visit Terumo Injection Filter Needle.
*Data on file
About Terumo Pharmaceutical Solutions Division
Terumo Pharmaceutical Solutions develops patient-oriented parenteral delivery solutions for therapeutic performance and safety. Globally trusted for quality and precision, Terumo offers pharmaceutical and medical device manufacturers around the world comprehensive product design and development services as well as a portfolio of injection, infusion, primary packaging, and CDMO solutions.
www.terumopharmaceuticalsolutions.com
About Terumo Corporation
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
www.terumo.com
1 Quantifying burden of intravitreal injection: questionnaire assessment of life impact of treatment by intravitreal injections (QUALITII)
2 Particles in Intravitreal Injections - Part I - West
3 Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients
Terumo Injection Filter Needle, a first step of the INFINO™ -Development Program
PM-08878
