Friday, August 27, 2021
Innovative Health Sciences, LLC management announced today that IHS has received FDA clearance for its Insignis™ Subcutaneous Needle Sets. This regulatory clearance allows IHS to sell and distribute its subcutaneous needle sets throughout the United States. The FDA clearance comes just weeks after the Company received the CE mark and ISO certifications permitting the sale of the full Insignis™ Syringe Infusion System throughout Europe.
The state-of-the-art Insignis™ Subcutaneous Needle Sets deliver an improved patient experience with reduced pain at a lower cost for the subcutaneous infusion of medications in the home, hospital, ambulatory, or clinic setting. New features include a butterfly-wing channel that maintains the needle at a 90-degree insertion angle, a needle safe-protection design using an audible and tactile wing closure that helps prevent needle stick injuries, and smaller needles. These new Insignis™ Subcutaneous administration sets can be used with typical infusion pump systems cleared for use for the delivery of medications to the subcutaneous tissues.
The 26-gauge subcutaneous needle sets are offered in single, bifurcated, trifurcated, and quad-furcated sets and are offered in 6mm, 9mm, 12mm, and 14mm sizes. “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,” says Andrew Sealfon, the Company’s Chairman and CTO. “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,” added Sealfon.
The Insignis™ Subcutaneous Needle Sets, available separately, are a subcomponent of the full next generation Insignis™ Syringe Infusion System, which has received CE mark and ISO certifications for European distribution, and is concurrently in process for FDA submission in the United States. The full system includes 5 separate products: infusion pump, IV Controller, (selectable rate flow controller that attaches to a catheter), OneSett™ (subcutaneous selectable rate flow controller combined with subcutaneous needle sets), fixed rate tubing for both intravenous and subcutaneous applications, and subcutaneous needle sets (now cleared for market in the U.S.).
The Insignis™ Syringe Infusion System is the first non-electric infusion pump available with a selectable flow rate controller for both intravenous and subcutaneous routes of administration, providing nearly the performance and accuracy of electronic infusion systems at a fraction of the cost.
Sealfon, Innovative Health Sciences’ founder, is a forty-year investor, innovator, and executive of the medical device industry. Inventor and founder of Repro-Med Systems, Inc. (KORU Medical Systems) and the FREEDOM™ system, Sealfon served as its President, Chairman of the Board, and Chief Executive Officer from September 1982 until July 25, 2018.