FDA approves fecal incontinence device for women
Pelvalon Inc. (Sunnyvale, Calif.) has received FDA approval for its Eclipse System for the treatment of fecal incontinence (FI) in adult women. The device is intended to treat FI in women 18 to 75 years old who have had four or more FI episodes in a 2-week period.
The device includes an inflatable balloon that is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, which reduces the number of FI episodes. The device is initially fitted and inflated by a clinician; after proper fitting, the patient can inflate and deflate the device at home as needed. The Eclipse System should be periodically removed for cleaning.
Adverse events associated with the device include: pelvic cramping and discomfort, pelvic pain, vaginal abrasion, vaginal redness, vaginal discharge, and urinary incontinence. All adverse events were mild or moderate, and none required any significant intervention.
New blood-draw technology reduces needle exposures
Velano Vascular (Philadelphia, Pa. and San Francisco, Calif.) has received FDA marketing clearance for a new technology that reduces the need for venipunctures during blood draws in the hospital. The technology is designed to reduce unnecessary pain and anxiety for patients receiving medications and hydration via I.V. delivery while aiming to provide a safer work environment for healthcare providers performing blood draws.
According to Valano Vascular, the disposable, single-use technology allows newly-placed peripheral I.V. catheters to be momentarily repurposed to draw blood from patients, reducing the need for additional needle sticks. The company's research has found that one of every three hospital patients is stuck two or more times daily for blood draws, with a significant subset of these patients receiving as many as three blood draws or more.