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The ARROW(R) VPS G4TM Device, a Vascular Positioning System from Teleflex, Streamlines Placement of Central IV Catheters, Study Reports

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Teleflex Incorporated (NYSE:TFX) , a leading global provider of medical
devices for critical care and surgery, announced that a newly published
clinical study demonstrates that the accuracy of the ARROW(R)
VPS G4TM Vascular Positioning System, with placements of peripherally
inserted central catheters (PICCs), can eliminate the use of
confirmatory chest X-rays.

The peer-reviewed study, titled “Successfully Eliminating Chest
Radiography by Replacing It with Dual Vector Technology and an Algorithm
for PICC Placement,” appeared in the June 2014 issue of the Journal
of the Association for Vascular Access (JAVA)
. The prospective,
non-randomized research showed that the VPS G4TM System achieved 100%
accuracy in placement of PICCs in an initial group of patients with
normal sinus rhythm (normal heartbeat). When used in this study the
device was also found to be useful in several patients who had atrial
fibrillation – that is, an irregular heartbeat.

Because the system enables accurate catheter placement, the study
concludes, confirmatory chest X-rays can be eliminated, when a steady
Blue Bullseye is illuminated, which in turn reduces radiation exposure
for patients, speeds the delivery of therapy and lowers direct costs.

The VPS G4TM System combines intravascular electrocardiogram (ECG),
intravascular Doppler ultrasound and a unique software algorithm to
accurately place catheter tips in the lower 1/3 of the Superior Vena
Cava (SVC) at the heart’s Cavo-Atrial Junction (CAJ). The VPS G4TM Device
is FDA cleared to eliminate chest X-ray in adult patients, when a steady
Blue Bullseye is achieved.

In the study, the VPS G4TM System was used with 31 patients selected from
the PICC patient population at Presence Saint Joseph Medical Center
(Joliet, Ill.). For purposes of the study, placement with the system was
considered accurate if the result obtained with a steady Blue Bullseye
was confirmed by a subsequent chest X-ray.

Of the 30 subjects, 25 had normal sinus rhythm – that is, a normal heart
rate. A steady Blue Bullseye was obtained for all 25 of those patients,
an accuracy rate of 100%. Five patients in the study were diagnosed with
atrial fibrillation. A steady Blue Bullseye was obtained for three of
those patients. Although a confirmatory chest X-ray is required for
patients with atrial fibrillation when using the VPS G4TM System, this
result was noteworthy, the study said, because some other positioning
technologies cannot be used with patients who have an abnormal sinus
rhythm. One of the patients was dropped from the study because of
technical difficulties.

Based on these findings, Presence Saint Joseph Medical Center, the site
of the study, determined that when the positioning system is used for
PICC placements in patients with normal sinus rhythm, a confirmatory
chest X-ray is not necessary.

“Our experience with the positioning system has been empowering in
multiple ways,” said Constance Girgenti, BSN, RN, VA-BCTM, lead author of
the article and the Vascular Access Coordinator at Presence Saint
Joseph. “The system enables us to provide safer, timelier care for our
patients, which is extremely important to us as clinicians. These
excellent outcomes have continued, and it has been very satisfying to
oversee the process from successful study to broader implementation.”

Elizabeth Donnellan, RN, BSN, VA-BCTM, co-authored the paper about the
positioning system’s use at Presence Saint Joseph. “Our vascular access
team is one of the few in the country that has also expanded its
practice to place central venous catheters, or CVCs,” said Donnellan.
“Now that we have established the effectiveness of the VPS G4TM System
for PICCs, we expect to start using it with central lines. Our next goal
is to eliminate confirmatory chest X-rays with CVCs.”

The study results are important for several reasons:

  • Reduced radiation exposure. If accurate placements can be made without
    relying on a confirmatory X-ray, patients are spared the exposure to
    the associated radiation.
  • Avoidance of treatment delays. At many hospitals, it can take up to
    several hours to obtain a confirmatory X-ray, which delays treatment,
    and then have the X-ray read by a radiologist, which further delays
    treatment.
  • Reduced costs. Confirmatory X-rays, which are read by radiologists,
    add costs. So do malpositioned catheter tips, which require adjustment
    of the line position. The positioning system can eliminate
    confirmatory chest X-rays in most cases and also minimizes catheter
    malpositions.

Teleflex provided no financial support for this study other than
supplying the device for the initial trial. The lead author has provided
consulting to Teleflex regarding technologies other than ARROW VPS G4TM.

About Teleflex Incorporated

Teleflex is a leading global provider of specialty medical devices for a
range of procedures in critical care and surgery. Our mission is to
provide solutions that enable healthcare providers to improve outcomes
and enhance patient and provider safety. Headquartered in Wayne, PA,
Teleflex employs approximately 11,500 people worldwide and serves
healthcare providers in more than 150 countries. Additional information
about Teleflex can be obtained from the company’s website at www.teleflex.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe
historical facts may constitute forward-looking statements. Any
forward-looking statements contained herein are based on our
management’s current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. These risks and
uncertainties are identified and described in more detail in our filings
with the Securities and Exchange Commission, including our Annual Report
on Form 10-K.

VA-BC is a registered trademark of the Vascular Access Certification
Corporation.

Teleflex, Arrow and VPS G4 are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates.

(c)
2014 Teleflex Incorporated. All rights reserved. MC-000199

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