The Insignis subcutaneous needle sets are used for the subcutaneous infusion of medications in the home, hospital, ambulatory, or clinic setting
Innovative Health Sciences (IHS) has secured clearance from the US Food and Drug Administration (FDA) for its Insignis subcutaneous needle sets.
The regulatory approval allows the company to sell and distribute its subcutaneous needle sets across the US.
The company has designed the Insignis subcutaneous needle sets to offer an enhanced experience with reduced pain at a lower cost for the subcutaneous infusion of medications in the home, hospital, ambulatory, or clinic setting.
Insignis consists of a butterfly-wing channel, which enables to maintain the needle at a 90-degree insertion angle and a needle safe-protection design that uses an audible and tactile wing closure to avoid needle stick injuries and smaller needles.
The Insignis subcutaneous administration sets are designed to be used with typical infusion pump systems cleared for use to deliver medications to the subcutaneous tissues.
IHS is offering the 26-gauge subcutaneous needle sets in single, bifurcated, trifurcated, and quad-furcated sets, as well as in 6mm, 9mm, 12mm, and 14mm sizes.
IHS chairman and CTO Andrew Sealfon said: “Patients using the Insignis™ needle sets will find that they obtain virtually the same flow as with common 24-gauge needles– but in a smaller, less painful 26-gauge needle.
“The needle sets are designed and manufactured with features to enhance the patient experience, including the easy to close safety needle design and no-tangle tubing for patient ease of use.”
Designed to be available separately, the Insignis subcutaneous needle sets are a subcomponent of the full next-generation Insignis syringe infusion system, which already secured CE mark and ISO certifications to sell in Europe.
Insignis syringe infusion system is also concurrently under process for FDA submission in the US.
The full system consists of five separate products such as infusion pump, IV Controller, OneSet, fixed-rate tubing for both intravenous and subcutaneous applications, and subcutaneous needle sets.
The IV Controller is a selectable rate flow controller that attaches to a catheter, while OneSett is a subcutaneous selectable rate flow controller combined with subcutaneous needle sets.
In addition, the Insignis syringe infusion system is claimed to be the first non-electric infusion pump available with a selectable flow rate controller for both intravenous and subcutaneous routes of administration.