On July 26, the U.S. Food and Drug Administration (FDA) approved the Finesse insulin patch-pen, a new type of insulin delivery device, for use with NovoLog rapid-acting insulin. In January, the device was granted FDA clearance and approved for use with Humalog rapid-acting insulin.
Finesse is a small, slim, plastic delivery device that contains a 200-unit reservoir for insulin, which is dispensed under the skin via either a 6-millimeter or a 9-millimeter cannula (a 27-gauge inserter needle is used to introduce the cannula). The device is designed to attach to the skin with adhesive and can remain in place for up to three days. Depending on the model, boluses of either 1 or 2 units of insulin are delivered by squeezing the two buttons located on either side of the device. (To prevent accidental boluses, both buttons must be pressed before insulin is dispensed.)
The device is intended for use with rapid-acting insulin only, so users will still need shots of long-acting basal insulin.
Jeffrey Purvin, Chairman and CEO of device manufacturer Calibra Medical, says, “Finesse combines the fast, discreet, needle-free features of wearable insulin pumps with the non-electronic simplicity, safety, and affordability of insulin pens.”
According to diabetes blogger Bernard Farrell, the manufacturer is currently working out some supply and design issues, and at present there is no definitive release date for the device.
For more information about Finesse, see the recent press release from Calibra.