FDA approves Chester firm's marketing of subcutaneous needle sets

CHESTER — Repro-Med Systems of Chester has received FDA approval to begin U.S. marketing of its new subcutaneous needle sets, which the company is promoting as the “HIgh Flo RMS” subcutaneous needle sets. The needle sets are intended for the delivery of medication to subcutaneous tissue. The needle sets have previously been approved and available for use by patients in Canada and Europe. “The FDA’s approval allows patients here in the U.S., where our products are manufactured, to enjoy the benefits realized currently by many patients overseas,” said Andrew I. Sealfon, company president. “Although we use a needle which is smaller in gauge than many needles being used for subcutaneous administration of certain drugs, our design results in flow rates comparable to, or better than, the flow rates of the larger needles. This can result in less pain and discomfort for the patient, less insertion difficulty for the patient and medical personnel, and shorter infusion times.” Officials said the needle sets are an ideal companion for its “FREEDOM60” syringe infusion system, used for patients who require regular drug infusions due to its portability and ease of use. Officials added the needle sets use custom designed, approximately 26-gauge needles, which have a smaller outside diameter than commonly used 24-gauge needles which, they added, translates into less “ouch” when the needles are inserted, and greater comfort throughout lengthy infusions. “We believe that patients who may be fearful of needles, or are uncomfortable with the thought of having to undergo lengthy infusions, will appreciate the potential benefits, as will health care providers,” Sealfon said.