FDA Approves Medtronic's New Automated Insulin Pump
September 28 2016 - 06:46PM
Dow Jones News
By Jeanne Whalen and Kate Linebaugh
The Food and Drug Administration approved for sale a significant
advance toward a so-called artificial pancreas for Type 1 diabetes
patients, a long-awaited insulin pump that aims to take some of the
guesswork out of blood-sugar control.
The product from Medtronic PLC, called the MiniMed 670G,
combines two devices that attach to the outside of the body -- a
pump that delivers insulin through a tiny tube inserted under the
skin, and a sensor that monitors blood glucose levels. The monitor
tells the pump when to increase or decrease insulin flow to keep a
person's blood sugar in a healthy range.
The device isn't fully automated -- users must enter their
planned carbohydrate intake at each mealtime, and adjust the sensor
twice a day by carrying out finger-prick tests to measure blood
sugar.
But doctors and patients called the MiniMed an important
breakthrough likely to improve glucose control, reduce
complications and lessen the constant worry of controlling Type 1
diabetes.
Existing diabetes pumps and monitors can automatically shut off
insulin flow when a person's blood sugar levels veer toward being
too low. But they can't automatically deliver insulin when a person
has high blood sugar, doctors said.
"We've been looking forward to a day like this for a long time,"
Derek Rapp, chief executive of the Juvenile Diabetes Research
Foundation, or JDRF, said in an interview. "Ultimately it means
less concern, less burden, more freedom and less fear."
Lori Laffel, a pediatric endocrinologist at the Joslin Diabetes
Center at Harvard University, said the approval was a big step
forward. Even so, she said patients still need to be able to take
care of their diabetes and know how to operate the pump and sensor.
"It doesn't make diabetes simply go away."
A clinical trial involving 124 patients who used the product for
three months reported no episodes of severe hypoglycemia or a
metabolic complication called ketoacidosis -- two serious
complications of Type 1 diabetes, according to results published
this month in the Journal of the American Medical Association.
There were 28 "device-related events," such as hardware or
software issues, that were "resolved at home," the study authors
wrote.
There were four serious adverse events, including appendicitis
and bacterial arthritis.
The Food and Drug Administration approved the product to treat
Type 1 diabetics 14 years and older. The agency carried out its
review in under four months, a speedy pace that Medtronic and
others called unusual.
"This first-of-its-kind technology can provide people with Type
1 diabetes greater freedom to live their lives without having to
consistently and manually monitor baseline glucose levels and
administer insulin," Jeffrey Shuren, director of the FDA's Center
for Devices and Radiological Health, said in a statement.
In part because the FDA review progressed more quickly than
expected, Medtronic won't be ready to begin selling the MiniMed
670G until next spring, Hooman Hakami, head of the company's
diabetes group, said in an interview. With the FDA approval in
hand, Medtronic will now begin approaching insurers to pitch them
on covering the product, he said.
He declined to give a price range for the MiniMed 670G, saying
it would vary depending on the payer.
Satish Garg, professor of medicine and pediatrics at the Barbara
Davis Center for Diabetes at the University of Colorado in Denver,
who helped conduct trials for the MiniMed 670G, said he is
concerned about whether insurance companies will pay for the new
system.
Dr. Garg said he lobbied for patients in the study to be able to
continue using the product after the trial concluded because the
results were so compelling. "It is going to change life with people
diabetes if it is properly instituted," he said.
Angie Platt, whose 13-year-old son participated in a clinical
trial of the product, said it allowed her and her husband to sleep
through the night for the first time in years, without having to
wake up periodically to check their son's blood sugar. The MiniMed
670G has also helped her son maintain healthier glucose levels, and
feel more energetic, she said.
"It has eased the burden of this disease tremendously," she
said.
Write to Jeanne Whalen at jeanne.whalen@wsj.com and Kate
Linebaugh at kate.linebaugh@wsj.com
(END) Dow Jones Newswires
September 28, 2016 18:31 ET (22:31 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
Medtronic (NYSE:MDT)
Historical Stock Chart
From Feb 2024 to Mar 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2023 to Mar 2024