Animas® Vibe™, the First Integrated Offering from Animas Corporation and Dexcom, Inc., Receives European CE Mark Approval
First CGM-enabled, waterproof insulin pump system now approved in Europe
WEST CHESTER, PA, June 2, 2011 /PRNewswire/ — Animas Corporation announced today the receipt of CE Mark approval for Animas® Vibe™, the first and only continuous glucose monitoring (CGM)-enabled insulin pump system with Dexcom G4™ CGM technology. Animas® Vibe™ brings together the unique features of an Animas® insulin pump and the convenience of Dexcom CGM, which is the only sensor approved for up to seven days of wear.
As a CGM-enabled system, the Animas® Vibe™ insulin pump functions as a receiver for the Dexcom G4™ Sensor. The system delivers real-time glucose information, alerts for high and low readings, and glucose trend information, enabling patients to make more informed decisions to help control their disease.* Unlike currently available CGM-enabled pump systems, Animas® Vibe™ displays glucose trends in colour and is waterproof.**
“The CE Mark approval for Animas® Vibe™ is a significant milestone for our R&D program and for people living with diabetes who are seeking better ways to manage their disease,” said Henry Anhalt, D.O., Chief Medical Officer, Animas Corporation. “Avoiding extreme highs and lows in glucose levels is crucial to controlling diabetes and reducing the risk of long-term diabetes complications. Animas® Vibe™ brings together leading pump and CGM technology to provide more freedom and flexibility to people living with diabetes.”
Clinical studies have shown that adults aged 25 and older with type 1 diabetes who use CGM therapy to help manage their disease often experience significant improvements in glucose control.¹ Furthermore, patients who use insulin pump therapy in combination with CGM obtain lower HbA1c levels relative to baseline and relative to patients who use multiple daily injections and self-monitoring of blood glucose.²
CGM-enabled systems, like Animas® Vibe™, provide patients with a more complete glucose picture (compared to fingersticks alone) – including customizable high and low alerts and rate-of-change alarms and trends. These features allow patients to make more informed decisions to help control their disease.*
“Diabetes is a demanding disease. Companies like Dexcom and Animas work tirelessly to provide people living with diabetes relief in the day-to-day, hour-by-hour management that is required with this chronic condition,” said Dr. Anhalt. “By combining high-performance pumping with state-of-the-art CGM technology, we’re able to bring people with diabetes tools to better manage their disease.”
Animas® Vibe™ marks the first integrated product offering from Animas Corporation, makers of high-performance insulin pump technology and Dexcom, Inc., the leader in continuous glucose sensing technologies. Now approved in Europe, the product will initially be available to people living with diabetes in the United Kingdom, Germany, France, Italy and Sweden.
Animas® Vibe™ offers:
- The latest technology available from Dexcom – Dexcom G4™, a tiny, round and flexible sensor with the smallest introducer needle as compared to Abbott Freestyle Navigator® and Medtronic Sof-Sensor®
- Advanced high-contrast colour pump screen technology, that displays glucose trends with coloured arrows and lines showing where and how fast glucose levels are shifting
- Dexcom sensor technology approved for up to seven days of wear, delivering more days of CGM data than those approved for a shorter duration
- Waterproof durability up to 12 feet (3.6 metres) for 24 hours for the insulin pump, with a Dexcom G4™ Transmitter that is waterproof at 8 feet (2.4 metres) for 24 hours
- Customizable alarms to indicate high and low glucose levels including a hypo-safety alarm fixed at 55 mg/dL (3.1mmol/L)
- Low basal increment (0.025 U/hr) across all available ranges (0.025 U/hr to 25.00 U/hr) for precise dosing
- Compatibility with Diasend® communications software, enabling patients to store, review and print both CGM and insulin pump data
The International Diabetes Federation estimates that 285 million people around the world have diabetes. This accounts for approximately 2.8 million people in the U.K., 7.5 million in Germany, 3.9 million in Italy, 4.2 million in France, and 484,400 in Sweden respectively.³
About Animas Corporation
As part of the Johnson & Johnson Family of Companies, Animas is dedicated to creating a world without limits for people with diabetes through a wide range of products, including Animas® Vibe™, the OneTouch® Ping® Glucose Management System, and the Animas® 2020 insulin pump. Animas, from the Latin word meaning “true inner self or soul,” has been committed since 1996 to meeting individual patient needs through the development of life-performance technology and customer service 24 hours a day, 7 days a week, 365 days a year. To learn more about Animas, visit http://www.animascorp.co.uk/
*A glucose reading must be confirmed with a fingerstick test before taking action.
** The Animas insulin pump is waterproof up to 3.6 metres for 24 hours. The Dexcom G4™ Transmitter is waterproof at 2.4 metres for 24 hours.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Animas Corporation and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Animas Corporation nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
¹ New England Journal of Medicine. 2008; 359:1464-76. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. Tamborlane, W. Beck, R., Buckingham, B: Pgs. 1464- 1475
² New England Journal of Medicine. 2010; 363:4. Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes. Bergenstal, R., Tamborlane,W., Ahmann, A.: Pgs. 315-318
³ “IDF Diabetes Atlas” International Diabetes Federation. 11 May 2011. http://www.diabetesatlas.org/content/eur-data.