Breakthrough Device Designation FAQ Letter
Tango Belt is a Breakthrough Device!
In 2016, then-President Obama signed the 21st Century Cures Act into law, intending to accelerate the discovery, development, and delivery of new cures for debilitating conditions. In part, this law encouraged the Food and Drug Administration to develop and apply a flexible approach to reviewing so-called breakthrough technologies in order “to provide patients and healthcare providers with timely access to medical devices,” while still meeting “rigorous standards for device safety and effectiveness.” The Breakthrough Device Designation program thus “reflects a commitment to device innovation”. Such devices promise more effective treatments for life threatening or debilitating conditions, offering significant advantages over existing standards for care, which is ultimately in the best interest of patients.
The Centers for Disease Control reports that over 300,000 older adults are hospitalized every year for hip fractures. Seemingly everyone we meet tells us about a loved one who unexpectedly fell, broke a hip, and underwent surgery, but struggled to fully recover. With these types of patients in mind, Active Protective designed the Tango® Belt, a wearable belt that deploys an airbag when sensors detect the wearer is experiencing a serious hip-impacting fall, cushioning the hip when it impacts the ground. Currently Active Protective is testing this design in a clinical study and results are still pending. A brief video with more information can be found at Tango Belt Introduction.
Active Protective sought Breakthrough Device Designation for the Tango Belt, believing in its potential to redefine the standard of care for older adults at risk for fall injury. We are delighted that the FDA accepted Tango Belt into this program and will press onward to successfully conclude the clinical study and market-acceptance review. We are determined to make Tango Belt available to the population of older adults at risk for major fall injury.
Below you will find a list of common questions and answers related to Tango Belt and the Breakthrough program. More details about the Breakthrough Device Program can be found at www.fda.gov. Details about Active Protective’s ongoing clinical study can be found at www.clinicaltrials.gov.
1) When will Tango Belt be available for sale?
Acceptance into the Breakthrough Device program does not guarantee that Tango Belt will be approved to market. We plan to file with the FDA in Q1 2024, but Tango Belt will not be available for sale until after the FDA has granted market authorization. We recommend to stay in touch with Active Protective to monitor its progress through this process. You can find more information at www.tangobelt.com.
2) Should I get Tango Belt?
While the Tango Belt is not currently available for sale, it is intended to be a prescription-only medical device. If you feel that you are at risk for experiencing a fall or if you are at risk of bone loss, please consult your doctor to discuss treatment options. Additional resources on managing fall risk can be found at STEADI - Older Adult Fall Prevention | CDC. Also, check your local health department for information about fall-related fractures.
3) How does Tango Belt work?
Tango Belt uses motion sensors to detect the wearer’s movements and a proprietary algorithm to deploy its airbag during serious hip-impacting falls. Tango Belt is the culmination after multiple years of development.
4) How many Devices are accepted into the Breakthrough Device Program?
The FDA does not publish numbers of all inductees into the program. However, you can find a list of all Breakthrough Devices that successfully reached market-acceptance at www.fda.gov. Since 2015, FDA has accepted 839 applications for Breakthrough Device Designation, and its predecessor programs.