Next Generation Teleflex Epidural Catheter Receives FDA Clearance

Limerick, Pa.-based Teleflex Inc. has received 510(k) clearance for its Arrow FlexTip Plus closed tip multi port epidural catheter from the U.S. Food and Drug Administration (FDA). The Arrow has been designed according to the same technology used for the open tip, single port catheter, which is the only coil-reinforced catheter that has 10 years of clinical research behind it, the company says.

The Arrow single port catheter has been proven, through clinical trial, to significantly reduce complications commonly associated with epidural catheters, such as vein cannulations and paresthesia. Paresthesia is a sensation of tingling, burning, pricking, or numbness of a person’s skin with no apparent long-term physical effect—also known as “pins and needles.” The advantage of the newer version of the Arrow, with multiple ports instead of just one, is that is allows clinicians various drug dispersion choices.

The coil-reinforced Arrow FlexTip catheter material is constructed of polyurethane, while a majority of spring wound catheters are made of nylon. The company claims this provides a balance of softness and strength, which promotes easier insertion, less movement out of the epidural space, better block quality, and higher satisfaction rates. The catheter is also designed to be resistant to kinks, with a soft, flexible tip with four lateral holes.

“Teleflex is adding the FlexTip Plus Closed Tip, Multi-Port to the Arrow catheter family to continue to support physicians with products that address the concerns anesthesiologists face on a daily basis,” said Cary Vance, president of the Teleflex Anesthesia and Respiratory Division. “The FlexTip Plus Closed Tip, Multi-Port is based on proven technology, helping anesthesiologists achieve the drug dispersion they prefer with the quality of care they demand for their patients.”

Teleflex provides specialty medical devices for a range of procedures in critical care and surgery.