Medtronic, Inc. MDT today announced
the U.S. Food and Drug Administration (FDA) approval of the MiniMed^® 530G
with Enlite^®, a breakthrough, first-generation artificial pancreas system
with Threshold Suspend automation for people with diabetes. Medtronic's
system is the first in the United States that can automatically stop insulin
delivery when sensor glucose values reach a preset level and when the patient
doesn't respond to the Threshold Suspend alarm. The MiniMed 530G system
incorporates the new Enlite sensor, Medtronic's most accurate and comfortable
continuous glucose sensor with a 31 percent improvement in overall accuracy
from the previous generation.[i]
"The diabetes community has eagerly awaited approval of this system that stops
insulin delivery when sensor glucose values fall below a predetermined
threshold," said Richard M. Bergenstal, M.D., executive director of the
International Diabetes Center at Park Nicollet Health Services in Minneapolis
and Clinical Professor for the Department of Medicine at the University of
Minnesota. "We are hopeful that advances such as this and improvements in the
accuracy of continuous glucose sensors will help people with diabetes strive
for better control of their diabetes."
"We're excited to bring yet another important 'first' to the United States.
The MiniMed 530G with Enlite can help people gain better control of their
diabetes versus multiple daily injections," said Katie Szyman, president of
the Diabetes business at Medtronic. "We are committed to advancing closed loop
algorithms, continuous glucose monitoring and insulin delivery technologies to
bring new artificial pancreas systems to market."
The Enlite sensor delivers better comfort and reliable CGM accuracy. In
addition to the 31 percent improvement in overall accuracy, the Enlite sensor
detects up to 93 percent of hypoglycemia episodes when predictive and
threshold alerts are on.[ii] The Enlite sensor is also 69 percent
smaller[iii] than the previous Medtronic sensor, to deliver improved comfort
in using continuous glucose monitoring. The new Enlite serter provides a
simpler sensor insertion process with a hidden-introducer needle.
The MiniMed 530G system was approved for use by people with diabetes ages 16
and older. Medtronic will conduct a post-approval study including children
ages two and older. The Enlite sensor can be worn for six days.
As a condition of approval, in addition to the post-approval study, Medtronic
will engage in direct patient follow up and will make certain manufacturing
accommodations. These commitments are consistent with the product approval by
the FDA and an accompanying warning letter issued to Medtronic on Sept. 19,
2013. Medtronic has already addressed many of the observations noted in the
warning letter and is committed to resolving the remaining observations as
quickly as possible and in accordance with the product approval requirements.
Medtronic is committed to providing safe and effective products for people
with diabetes.
Medtronic will begin ramping up production immediately to prepare for a launch
of the MiniMed 530G in the next several weeks. In the meantime, customers can
find additional product and important safety information at
www.medtronicdiabetes.com.
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