Asante Solutions Receives FDA Clearance and CE Mark Approval for Pearl Insulin Pump

Asante’s Pearl insulin pump has received FDA clearance and CE Mark approval.

In welcome news, Asante Solutions received FDA clearance for its new Pearl insulin pump in mid-May and European approval (the CE Mark) in April. The Pearl is the first fully programmable pump to be cleared by the FDA since the agency instituted new guidelines in 2010 that made the approval process for insulin pumps more stringent. The pump’s design includes several innovative features. First, the Pearl uses prefilled insulin cartridges, which eliminates filling the reservoir and simplifies overall usage. The insulin cartridges are the standard 300-unit “pen-type” cartridges, which are approved for up to seven days in the pump – this would be the only pump to use the cartridges. While the infusion cannula site should be changed every three days, not needing to change the reservoir and infusion set tubing could be a real benefit. Although the use of prefilled insulin cartridges in insulin pumps is not new (back in the day some of Disetronic’s devices included this feature although the pump wasn’t popular due to other detractions), it certainly could make the Pearl a real choice for novice pumpers and a little bit more convenient for experienced users. Despite the 300-unit prefilled cartridge, the Pearl is able to remain small and sleek (3.88" x 1.72" x 0.75") due to Asante's innovative drive mechansism. The Pearl also has a semi-disposable modular design consisting of a permanent controller (with the buttons and display) and a disposable pump body that clip together to form a long, slim unit. The pump body, which contains a battery and all the necessary moving parts, is replaced when the cartridge is empty. This modular design would reduce the high startup cost of buying a pump, and the pump body kits are “pay as you go,” which means a monthly co-pay for those with insurance – this is similar to the Insulet payment model. Additionally, the Pearl has several additional user-friendly features, including occlusion alarms that gradually get louder rather than start at a loud volume, a built-in flashlight (to help identify bubbles in the tubing), and familiar tubing choices that are automatically primed upon attachment. Asante has yet to announce the launch date for the Pearl; for now, the company is focusing on building up its operations and customer support facilities.  –KRC