MiniMed stages big breakthrough.

A new high-tech insulin pump that uses wireless technology to measure doses is prompting some to hail the system as a major development in the treatment of diabetes--and could be a boon to one of its creators, Northridge-based Medtronic MiniMed.

The U.S. Food and Drug Administration recently approved the Paradigm system made by MiniMed and Becton Dickinson & Co., based in New Jersey.

The system integrates MiniMed's Paradigm insulin pump with Becton Dickinson's glucose monitor which uses MiniMed's wireless communications software.

Benjamin C. Andrew, an analyst with William Blair & Co. in Chicago, said the new system would likely become a big seller for MiniMed.

"It's hard to say how much it could bring," he said. "I wouldn't be surprised if it's a quarter or a third of its hardware revenue."

Last year MiniMed earned an estimated $475 million with about $230 million coming from its insulin pump or hardware business, Andrew said, noting that there is no similar wireless pump in the market.

The company itself would not project sales for the new insulin pump system. As it is, MiniMed has about 80 percent of the insulin pump market.

But for medical observers, the new system is all about helping diabetes patients.

"This is a system that will definitely improve the quality of lives for our patients," said Francine Kaufman, a pediatric endocrinologist at Children's Hospital in Los Angeles and past president of the American Diabetes Association 

MiniMed, a unit of Minneapolis-based Medtronic Inc., is the largest manufacturer of insulin pumps with a market share valued at about $600 million. Medtronic acquired MiniMed in 2001 from its founder and owner, Alfred E. Mann, for $3.7 billion.

MiniMed, established in 1983, developed the first insulin pump that same year and has continued to develop improved versions of the device since then. The company says it plans to eventually develop a blood sugar sensing and insulin delivery system that will eliminate the pricking of fingers to produce blood for current blood monitors.

The new Paradigm system features a device that calculates how much insulin a patient needs after a meal and then signals an implanted pump to provide that dose.

MiniMed officials say the system combines two steps in diabetes management, blood sugar monitoring and insulin dosing through wireless technology.

"This new integrated pump and monitor system is a major breakthrough in diabetes management," said Bruce Bode, medical director of the diabetes Resource Center in Atlanta.

"The new pump system is so smart it recommends the proper insulin dosage to the patient, after considering a number of variables, such as the amount of insulin previously delivered and still active in the body."

Eliminating errors

The automatic nature of the blood dosage measurement eliminates errors by patients who must mentally calculate the amount of insulin needed through a complex process, the company said.

The pump's calculator, dubbed "Bolus Wizard," calculates the amount of dosage needed using information preset by the patient. The dosage requirement is critical since high or low blood sugar levels can result in loss of consciousness or death as well as other long-term complications such as amputation and blindness.

The system retails for $6,000 and becomes available this week nationwide.

Jeffery McCaulley, vice president and general manager for MiniMed, said the new technology allows the system to create the first artificial pancreas in medical history.

"We have known for some time that an insulin pump can more closely mimic a healthy pancreas," he said.

"Now we have harnessed the full potential of the pump with our patented (technology)."

Despite the high-end electronics, the patient must still prick his finger on a lancet to produce blood for a glucose monitor which must then send the reading through a wireless connection to the pump. The pumps are often worn on a belt like a pager.

The FDA says more than 200,000 diabetics have insulin pumps implanted in their abdomens, but only now is a programmable system available that can provide exact doses for patients even while they sleep.

Progress in treatments

Mark D. McClellan, FDA commissioner, said in a statement that the agency sees diabetes treatments to continue to evolve in the coming years.

"FDA is prepared to meet the new opportunities of combination products (like the Paradigm system) by adapting its resources to address these new technologies," he said.

In most people, the body breaks down food into sugar that then enters the bloodstream which in turn signals the pancreas to make insulin once blood sugar levels increase and reach a certain level. Insulin unlocks the body's cells and allows the sugar to enter and be turned into energy.

There are two types of diabetes, affecting 4 million people in the U.S. Type 1 diabetes affects more than 1 million people and results in the destruction of insulin-producing cells in the pancreas by the immune system.

Type 2 diabetes, which afflicts about 3 million people, is either the result of the pancreas not producing enough insulin or the body's cells being unable to use the insulin properly.

According to the American Medical Association, diabetes is a leading cause of blindness, kidney failure and amputations and greatly raises the risk of heart attacks. Each year about 180,000 Americans die from the disease. But some diabetics are able to control their disease through medication, diet and exercise.