SUNNYVALE, Calif., April 12, 2011 /PRNewswire/ — Asante
Solutions, Inc. (Asante), a medical device company focused on
diabetes care, today announced it received the CE mark for its
Pearl Insulin Pump, the only insulin pump that uses a pre-filled
insulin cartridge. The CE mark is a European proof of conformity
that certifies the product meets EU safety, health and
environmental requirements. Asante has begun discussions with
potential distribution partners in Europe.
“This important regulatory milestone brings us one step closer
to our goal of delivering a sensible solution to the growing but
underserved insulin pump market,” said Phil Hopper, Asante CEO and
President. “Once available, we believe the small and sleek Pearl
will be the simplest-to-operate pump on the market. The Pearl is a
fully featured insulin pump addressing the imperatives of safety,
reliability, and ease of use required to meet the needs of people
with diabetes using intensive insulin therapy.”
The Pearl Insulin Pump is designed to simplify diabetes care for
the more than 500,000 people worldwide who use an insulin pump and
those considering insulin pump therapy. Unlike the insulin pumps
currently available, which require users to manually fill an
insulin reservoir using a vial of insulin and syringe, the Pearl
Insulin Pump uses a 300-unit, pre-filled insulin cartridge that
simplifies the process of loading the pump and filling the infusion
set by reducing the number of steps required and thereby creating a
less time-consuming and more convenient process.
“The Pearl is an important evolution in the design of insulin
pumps,” said Dr. Anthony D. Andre, Ph.D., CPE, founder of Interface
Analysis Associates and current president of the Human Factors and
Ergonomics Society, who has performed a number of studies on
insulin pumps and other drug delivery systems for diabetes
patients. “I believe the Pearl design will reduce errors, safety
risks, and user frustrations with key eleme
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