Asante Solutions接收FDA间隙和CE标志珍珠胰岛素泵的批准

Asante的珍珠胰岛素泵已获得FDA清除和CE标志批准。

在欢迎新闻中，Asante解决方案于5月中旬和欧洲批准（CE Mark）的新珠胰岛素泵获得FDA清关。珍珠是第一个由FDA清除的全部可编程泵，自2010年的机构在2010年制定了新的准则，这使得胰岛素泵的批准过程更严格。泵的设计包括多种创新功能。首先，珍珠使用预填充的胰岛素盒，消除填充储存器并简化了整体使用。胰岛素墨盒是标准的300单元“笔式”墨盒，在泵中批准最多七天 - 这将是使用墨盒的唯一泵。虽然输液套管遗址每三天应该改变一次，但不需要改变水库和输液套管可能是真正的好处。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.