Tandem Diabetes Care Announces FDA Clearance of the t:slim™ Insulin Delivery System
Smallest Insulin Pump System and First-Ever with a Touch Screen
SAN DIEGO, Nov. 16, 2011 /PRNewswire via COMTEX/ -- Tandem Diabetes Care, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA's new Infusion Pump Improvement Initiative.
"With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy," said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. "In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, 'make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.' The t:slim's touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike."
Of approximately 1.5 million people in the U.S. with type 1 diabetes,(i) industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life.(ii) Tandem Diabetes Care believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy.
"Medical devices are often designed for the hospital setting, not for everyday life. Things like size, look, and feel are often overlooked," said Dr. Timothy Bailey, director of the Advanced Metabolic Care and Research Institute. "Patients need an insulin pump designed to easily integrate into their daily lives. The device needs to be unobtrusive and look more like the consumer electronics they already use every day."
The t:slim has a vivid color touch screen and was designed to make diabetes management easier to teach and easier to learn. Additional user-oriented features of this insulin pump include an eco-friendly rechargeable battery and USB connectivity to a web-based therapy management software.
As part of Tandem Diabetes Care's commitment to excellence, the Company will be building its customer support, sales, clinical, and business operations in preparation for U.S. launch during the first half of 2012.
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About the t:slim Insulin Delivery System
The t:slim is a modern, programmable insulin infusion pump for people with diabetes mellitus age 12 and greater who require insulin. The pump's streamlined interface provides users with quick and easy access to all the device's functions. The t:slim features Tandem's proprietary micro-delivery technology, which provides safe and accurate insulin delivery from a 300-unit cartridge, and allows for the device's slimmest-in-class form factor.
About Tandem Diabetes Care, Inc.
Dedicated to advancing the management of diabetes, Tandem Diabetes Care, Inc.(www.tandemdiabetes.com) is a privately held company with novel technology and a comprehensive, user-centric and integrated approach to product development and customer care. Tandem is based in San Diego, Calif.
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(i) Centers for Disease Control and Prevention. Media fact sheet and National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011
(ii) Insulin Pump Therapy: Guidelines for Successful Outcomes whitepaper, American Association of Diabetes Educators, 2008
SOURCE Tandem Diabetes Care, Inc.
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