Federal regulators have approved a new treatment for diabetes developed by Medtronic that brings medicine closer to the creation of an artificial pancreas.
The Food and Drug Administration approved the Fridley-based company's MiniMed 530G with Enlite system, which can automatically stop insulin delivery when a sensor detects dangerously low blood-sugar levels, known as hypoglycemia.
"This is a huge deal for our business and, most importantly, for our patients," said Jeff Hubauer, vice president and general manager of Medtronic's insulin delivery business, in an interview. "As we take incremental steps in the journey toward an artificial pancreas, we get more confident."
The number of adults with diabetes has been exploding in the United States and throughout the developed world. More than 25 million Americans now have the disease, equal to about 8 percent of the total population. Up to 79 million Americans exhibit elevated blood sugar levels that are considered a precursor to the development of diabetes.
The current market for insulin pumps and continuous glucose monitors is worth about $2.5 billion, but that number is expected to keep rising as more of the world population is diagnosed with the disease.
The new Medtronic system includes a pump worn externally that communicates wirelessly with a continuous glucose monitor to deliver the optimal amount of insulin to patients. The device addresses a pervasive fear among diabetics that their blood-sugar levels may drop precipitously while they sleep, possibly leading to a coma.
If a person's glucose levels reach a worrisome threshold, an alarm will sound with the Medtronic system. If the alarm fails to rouse the slumbering patient, the system will suspend insulin delivery for two hours.
Dr. Richard Bergenstal, executive director of the International Diabetes Center at Park Nicollet Health Services in St. Louis Park, said in a statement the diabetes community has "eagerly awaited" the advent of this type of system.
"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," Bergenstal said.
Medtronic said it will begin producing the new product in the next several weeks.
Katie Szyman, president of Medtronic's diabetes business, said the company is committed to making further advances in "continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market."
A fully automated artificial pancreas system would closely mimic the insulin delivery of a healthy pancreas by using advanced technology that continuously monitors glucose levels and automatically adjusts insulin delivery with little or no patient interaction.
When that advanced device will hit the market is unclear, but it has been many decades in the making. Hubauer said Medtronic strives to introduce incremental improvements to current products every 18 to 24 months, but declined to say when a full artificial pancreas may become available.
The FDA approval came about six months earlier than investors expected, said Danielle Antalffy, an analyst at Leerink Swann Research in New York, in a note to clients Friday. The new device could spark a turnaround in Medtronic's diabetes business during the next several quarters, averting expected declines, she said.
"Medtronic is better positioned to reinvigorate its U.S. diabetes sales growth, which has declined now for three consecutive quarters," she wrote. "Most importantly, the 530G should help Medtronic address a backlog of patient upgrades that have likely built over the last few quarters in anticipation" of approval, she said.
Friday's news came after the FDA issued a warning letter to the company Sept. 19 regarding product quality and the manufacturing processes associated with some of the company's insulin pumps and monitors. The company has manufacturing sites in Northridge, Calif., where the diabetes business is based, and in Juncos, Puerto Rico.
A condition of FDA approval is that Medtronic conduct direct patient follow-up and "make certain manufacturing accommodations."
The recently approved system is for use only by people over age 16, for now.
Medtronic said it will conduct a post-approval study that will include children 2 and older to examine the possibilities of extending the product's use.
Janet Moore • 612-673-7752
Bloomberg contributed to this report.
