Covidien COV, a leading global provider of healthcare products, has
released positive final results from its DURABILITY II study and promising
preliminary data from its DEFINITIVE AR trial at the Vascular Interventional
Advances (VIVA) 2013 conference in Las Vegas, NV. These studies demonstrate
the safety and effectiveness of technologies used in the treatment of
peripheral arterial disease (PAD). The DURABILITY II three-year results
support the use of a single long EverFlex™ self-expanding stent. DEFINITIVE AR
acute 30-day data shows early success with the combined use of directional
atherectomy and a drug-coated balloon (DAART) in treating lower limb blockages
in PAD patients.
“Covidien's extensive clinical research program in vascular therapies aims to
provide rigorous evidence that physicians can use to make treatment decisions
for conditions, such as peripheral arterial disease – a common vascular
disease affecting over 200 million people worldwide,” said Mark Turco, M.D.,
Chief Medical Officer, Covidien Vascular Therapies. “Providing clinically
relevant data – like the DURABILITY II and DEFINITIVE AR trials - to
physicians is a must, and I'm proud of Covidien's work to drive this
evidence.”
In DURABILITY II, the use of the EverFlex™ stent demonstrated a low need for
repeat procedures (revascularization of treated lesions) as well as a low rate
of stent breakage (fracture rate). Stent fracture is a known cause of artery
reblockage leading to repeat procedures. Final results support the long-term
safety and effectiveness of the EverFlex stent in a challenging PAD patient
population.
In the DEFINITIVE AR randomized study, early results show that physicians are
achieving better acute procedural success when treating patients with
directional atherectomy plus anti-restenotic therapy (DAART) versus using a
drug-coated balloon alone. The results also showed superior lumen gain with
DAART treatment with fewer vessel tears (dissections) and no “bailout” stents
required.
For a summary of research findings, please visit Covidien DURABILITY II and
Covidien DEFINITIVE AR.
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