FDA Clears Teleflex's Latest PICC

Teleflex Incorporated (TFX - Snapshot Report), a worldwide provider of medical devices has announced the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Arrow ADVANTAGE pressure-injectable peripherally inserted central catheter (PICC) for central venous pressure (CVP) monitoring indication.

The Arrow ADVANTAGE PICC is packed with unique features that enhance patient comfort, insertion and ease of use by clinicians. The addition of the CVP monitoring indication to the PICC will enable assessment of a patient’s cardiovascular system.

This will enhance Teleflex’s Arrow catheter portfolio and strengthen its Critical Care segment.

The Critical Care segment recorded a 7.5% year over year increase in revenues to $256.2 million in the first quarter of fiscal 2012, aided by robust sales of catheters. Total revenues 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 as new products and price mark-up accounted for the increase in total revenues in the last quarter.

The company’s focus on consistent growth with new product introductions and portfolio expansion has continued to yield results. Teleflex earlier received 510(k) clearance for its Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter and antithrombogenic claims on the Arrow PICC with Chlorag+ard technology.

Management at Teleflex believes that its latest offering represents the next generation of non-coated pressure injected PICCs. The correlation of a patient’s CVP alterations with the clinical status can be used to determine the adequacy of volume of venous blood as well as cardiovascular function. CVP measurements can also indicate how well the right atrium and ventricle can pump blood, a measure of cardiac efficiency.

Increased radiopacity of Teleflex’s Arrow ADVANTAGE PICC enables observation under fluoroscopy and x-ray as well as pressure injection indication in the distal lumen at 5ml per second. The distal lumen of Arrow ADVANTAGE PICC is in accord with the Arrow VPS System. It thereby allows the PICC to be used in conjunction with the innovative tip location technology of the Arrow VPS.

The PICC also boasts other exclusive features such as the Arrow Blue Flex Tip, designed to minimize vessel trauma. The risk associated with an adverse mix of medication and precipitate formation is lower, due to the staggered PICC exit ports. The PICC can also eliminate skin nick because of the presence of GlideThru peel-able sheath over dilator. The SecondSite adjustable hub helps to fasten the catheter at any insertion site.

Catheter-related thrombosis is a critical concern for clinicians. As per clinical studies, the risk of thrombosis is directly proportional to the increase in French size of the catheter. Also worth mentioning in this context is the taper-free catheter design of Teleflex’s Arrow ADVANTAGE PICC which also works to minimize the risk of catheter-related thrombosis.

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. MesaLaboratories (MLAB - Snapshot Report) and Given Imaging (GIVN), which operate in similar business segments, are also making efforts to boost their top-line via new product introductions and acquisitions.

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