Animas is New Pump Player on the Block

R-1000 Gets 510(k) FDA Approval

| Apr 1, 2000

Animas Corporation will be having its coming-out party to the diabetes community this May.

On February 10, the Frazer, Pennsylvania-based company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its R-1000 insulin infusion pump. In addition, Animas will file for the CE mark so that it can sell the R-1000 in Europe.

With Animas's FDA approval, there are now three players in the pump market, with MiniMed and Disetronic being the other two. According to Animas, the R-1000 pump is a "user-friendly" pump, equipped with a menu-driven format.

Like an ATM Machine

"It's like an ATM machine," says Audrey Finkelstein, vice-president of marketing and clinical affairs at Animas. Finkelstein points out that with existing pump technology, you have symbols that the user must memorize. With the R-1000, however, everything is explained for you. "Whatever you want, you just scroll to it and press 'Enter.'"

According to Finkelstein, the R-1000 speaks four languages: English, Spanish, French and German. She adds that by touching buttons on the R-1000 menu, it will tell you the time, what program you are in, and how much insulin you have left in the cartridge. By scrolling and pressing "Enter" the user can also bolus and check history.

"You take someone who has never used the pump before and the nice part about it is that you just say, 'Here are your buttons, here is how you scroll, and here is where you enter,'" says Finkelstein. "They take it from you and they immediately know how to use it."

The R-1000 also has both a high-efficiency LED backlight and is water-tight.

"We have it tested for 12 feet of water," says Finkelstein. "So you can't go deep-sea diving, but can go swimming in most swimming pools."

Expanding Production to Meet Demand

Dr. Katherine Crothall, president and CEO of Animas, adds, "Because of the overwhelming interest and enthusiasm expressed by the diabetes community for the R-1000 pump, we are expanding our manufacturing facilities to meet the anticipated demand for the product."

Animas will distribute the R-1000 through a combination of its direct sales representatives and Insulin Infusion Specialties of Metairie, Louisiana.

"We want to first go to the diabetes educators and let them know what we have," says Finkelstein, pointing out that Medicare covers the R-1000 in patients with type 1 diabetes only. She also says that Medicaid, in some states, will cover the R-1000, but advises that people check with their state's Medicaid provider. "I know that in New York, Medicaid gives 100 percent coverage of the R-1000."

Competitively Priced

The R-1000, according to spokespersons at Animas, will be "competitively priced" with other insulin pumps on the market. Animas estimates that revenues for the R-1000 and its supplies will be in excess of $8 million for 2000. Animas will introduce its own infusion sets in the first quarter of next year and expects revenues to exceed $25 million for 2001.

Finkelstein says that for the time being, pump users can use any MiniMed or Disetronic infusion set on the R-1000.

Next Step: An Artificial Pancreas

In addition to improved infusion, Animas is also developing a long-term implantable optical glucose monitor with an ultimate objective of combining its pump and glucose monitor to provide "closed-loop control of blood sugar," thereby creating an artificial pancreas.

Animas says this closed-loop device is at least three years from commercialization.

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Categories: Blood Sugar, Diabetes, Food, Government & Policy, Insulin, Insulin Pumps, Type 1 Issues


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