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FDA Approves Marketing of RMS Subcutaneous Needle Sets

June 1, 2011 By Bio-Medicine.Org

CHESTER, N.Y., June 1, 2011 /PRNewswire/ — Repro-Med Systems,
Inc., (REPR.PK) announced today that it has received approval from
the Food and Drug Administration (FDA) 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.  Repro-Med
Systems, Inc. utilizes the name RMS Medical Products.

“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, president of
the company, based in Chester, NY.  “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,” Sealfon added.

The needle sets are an ideal companion for RMS Medical Products’
FREEDOM60® Syringe Infusion System, which has enhanced the
lifestyle of numerous patients requiring regular drug infusions due
to its portability and ease of use.  FREEDOM60® enjoys
widespread use by ambulatory patients at home as well as those in
healthcare facilities.  “Even though the RMS Subcutaneous
Needle Sets provide advanced fluidics, the pricing will be highly
competitive, just as FREEDOM60® has been in the infusion pump
market,” Sealfon said.

The RMS Subcutaneous Needle Sets use custom designed,
approximately 26-gauge needles, which have a smaller outside
diameter than commonly used 24-gauge needles.  This translates
into less “ouch” w

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SOURCE

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