Asante Solutions, Inc. Receives CE Mark for Pearl(TM) Insulin Pump
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 elements of the insulin pump interaction process and create an easy, efficient, and satisfying process for diabetes patients.”
This device is not yet available for sale in the United States, pending 510(k) clearance.
About Asante Solutions, Inc.
Based in the heart of Silicon Valley, Asante Solutions, Inc. is a privately-held medical device company developing simple solutions for diabetes. The company, founded in Denmark, was previously known as M2 Medical, Inc. For more information, visit www.asantesolutions.com.
SOURCE Asante Solutions, Inc.