FDA Clears Teleflex's Latest PICC - Analyst Blog
July 03 2012 - 11:33AM
Zacks
Teleflex Incorporated (TFX), 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) 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.
GIVEN IMAGING (GIVN): Free Stock Analysis Report
(MLAB): ETF Research Reports
TELEFLEX INC (TFX): Free Stock Analysis Report
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