Recent Device Approvals: Animas Vibe System
Press Release
By:
Ref: FDA
Published: 12/18/2014
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Animas Vibe System
PMA Applicant: Animas Corporation
Address: 200 Lawrence Drive, West Chester, PA 19380
Approval Date: November 25, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130007a.pdf
What is it? The Animas Vibe System is a continuous glucose monitor (CGM) and insulin pump combination for people with diabetes. The CGM is an externally-worn device with an internal sensor that continuously measures glucose values in the fluid around the cells (interstitial glucose) for up to seven days (the life of the sensor). The insulin pump delivers insulin as a single dose (bolus) when needed or continuously throughout the day (basal insulin). The insulin pump displays glucose values from the CGM along with glucose trending information, alerts and alarms, and insulin pump data and information.
How does it work? The Animas Vibe System consists of the Animas Vibe Insulin Pump and Dexcom G4 PLATINUM CGM sensor and transmitter. The Animas Vibe Insulin Pump delivers insulin under the skin through an infusion set. The CGM sensor is a small wire that is inserted under the skin of the abdomen and measures interstitial glucose values. These values are sent through the transmitter to the insulin pump. The Animas Vibe Insulin Pump contains the Dexcom G4 PLATINUM CGM software that converts the sensor signals to readings in mg/dL. The insulin pump displays glucose readings, trend information and patterns, and provides alerts and alarms.
Glucose trends, alerts and alarms help users stay within their target glucose ranges.
When is it used? The Animas Vibe Insulin Pump is used by people with diabetes who need insulin.
The Dexcom G4 PLATINUM CGM sensor and transmitter are used to complement, not replace, information obtained from a standard home glucose monitoring device. The Dexcom G4 PLATINUM CGM sensor and transmitter are used to aid people with diabetes in managing their disease. The sensor alarms may help detect episodes of high glucose levels (hyperglycemia) and low glucose levels (hypoglycemia). Interpreting CGM results should be based on the trends and patterns seen with several consecutive readings over time.
The Animas Vibe System is intended for single patient use in persons age 18 and older and requires a prescription.
What will it accomplish? People with diabetes can use the glucose information from the CGM to help determine patterns in their glucose levels. The Animas Vibe System alerts users when glucose values are approaching potentially dangerously high and/or dangerously low levels. People with diabetes can use the insulin delivered from the pump to help keep their blood glucose at a safe level. The Animas Vibe System can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range. A standard home blood glucose meter should be used with the Animas Vibe System to obtain more accurate readings of actual blood glucose levels.
When should it not be used? The Animas Vibe System should not be used:
During Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment.
Remove the Dexcom G4 PLATINUM sensor, and transmitter, before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.
With medicines containing acetaminophen (such as Tylenol).
Taking medicines with acetaminophen while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online
Product Name: Animas Vibe System
PMA Applicant: Animas Corporation
Address: 200 Lawrence Drive, West Chester, PA 19380
Approval Date: November 25, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130007a.pdf
What is it? The Animas Vibe System is a continuous glucose monitor (CGM) and insulin pump combination for people with diabetes. The CGM is an externally-worn device with an internal sensor that continuously measures glucose values in the fluid around the cells (interstitial glucose) for up to seven days (the life of the sensor). The insulin pump delivers insulin as a single dose (bolus) when needed or continuously throughout the day (basal insulin). The insulin pump displays glucose values from the CGM along with glucose trending information, alerts and alarms, and insulin pump data and information.
How does it work? The Animas Vibe System consists of the Animas Vibe Insulin Pump and Dexcom G4 PLATINUM CGM sensor and transmitter. The Animas Vibe Insulin Pump delivers insulin under the skin through an infusion set. The CGM sensor is a small wire that is inserted under the skin of the abdomen and measures interstitial glucose values. These values are sent through the transmitter to the insulin pump. The Animas Vibe Insulin Pump contains the Dexcom G4 PLATINUM CGM software that converts the sensor signals to readings in mg/dL. The insulin pump displays glucose readings, trend information and patterns, and provides alerts and alarms.
Glucose trends, alerts and alarms help users stay within their target glucose ranges.
When is it used? The Animas Vibe Insulin Pump is used by people with diabetes who need insulin.
The Dexcom G4 PLATINUM CGM sensor and transmitter are used to complement, not replace, information obtained from a standard home glucose monitoring device. The Dexcom G4 PLATINUM CGM sensor and transmitter are used to aid people with diabetes in managing their disease. The sensor alarms may help detect episodes of high glucose levels (hyperglycemia) and low glucose levels (hypoglycemia). Interpreting CGM results should be based on the trends and patterns seen with several consecutive readings over time.
The Animas Vibe System is intended for single patient use in persons age 18 and older and requires a prescription.
What will it accomplish? People with diabetes can use the glucose information from the CGM to help determine patterns in their glucose levels. The Animas Vibe System alerts users when glucose values are approaching potentially dangerously high and/or dangerously low levels. People with diabetes can use the insulin delivered from the pump to help keep their blood glucose at a safe level. The Animas Vibe System can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range. A standard home blood glucose meter should be used with the Animas Vibe System to obtain more accurate readings of actual blood glucose levels.
When should it not be used? The Animas Vibe System should not be used:
During Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment.
Remove the Dexcom G4 PLATINUM sensor, and transmitter, before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.
With medicines containing acetaminophen (such as Tylenol).
Taking medicines with acetaminophen while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online