FDA Clears Teleflex's Catheter

On May 30, 2012, worldwide medical devices provider, Teleflex Incorporated (TFX - Snapshot Report) announced that it has received the U.S. Food and Drug Administration (FDA) 510(k) clearance for its Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter. This will enhance the company’s Arrow catheter portfolio and strengthen its Critical Care segment.

The Critical Care segment recorded 7.5% increase in revenue to $256.2 million during the first quarter of fiscal 2012, aided by robust sales of catheters. Total revenue came in at $387.8 million, up 9.5% year over year. Current product development underlines the company’s ability to further boost its top-line growth as new products and price mark-up accounted for increase in total revenue in the last quarter.

The company’s focus on attaining profitable and consistent growth with new product introduction and portfolio expansion is yielding results. Teleflex earlier received FDA 510(k) clearance for its antithrombogenic claims on the Arrow Peripherally Inserted Central Catheter (PICC) with Chlorag+ard technology.

The Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter is a development on the company’s market leading Arrow FlexTip Plus Open Tip, Single-Port epidural catheter. The Open Tip, Single-Port epidural catheter, the only coil-reinforced catheter, is well regarded in its ability to reduce complications which other epidural catheters could not prevent. Examples include vein cannulations and paresthesia. The statistical success of Open Tip, Single-Port catheter is supported by more than a decade of clinical data.

The FlexiTip Plus Closed Tip, Multi-Port has a soft flexible tip with four lateral holes and provides exceptional kink resistance and is based on proven technology. The new addition to the Arrow catheter family will further support clinicians by reducing the problems faced by anesthesiologists on a regular basis. Management therefore believes that the FlexiTip Plus Closed Tip, Multi-Port can help anesthesiologists in improving the quality and standard of patient care.

The new product uses the same technology as the Open Tip, Single Port catheter but its addition to the Arrow FlexiTip Plus will render various drug dispersion choices to critically aid clinical results. The FlexiTip Plus catheters are made of polyurethane unlike the majority of other spring wound catheters which are made of nylon.

Teleflex, headquartered in Limerick, Pennsylvania is a manufacturer and provider of medical devices used in critical care and surgery. Its initiative of developing new, innovative products should help drive sales further. Mesa Laboratories (MLAB - Snapshot Report) and Given Imaging (GIVN), which operate in similar business segments, are also making efforts to boost their top-line growth via new product introduction and acquisition.

Teleflex currently retains a Zacks #3 Rank, which translates into a short-term Hold rating.