|Covidien Announces Nine-Month Results of DURABILITY Iliac Study, Addition of Iliac Indication for EverFlex™ Stent System at VIVA 2014|
EverFlex™ Self-Expanding Stent System Safe and Effective for the Treatment of Iliac Stenosis
“The EverFlex™ and Protégé™ GPS™ self-expanding stent systems
demonstrated strong patency rates even in difficult to treat calcified
lesions in patients with iliac disease,” said Dr.
The prospective, multi-center, non-randomized clinical study, which was
led by Dr. Faries and Dr.
Secondary outcomes were also favorable. The nine month primary patency by Kaplan-Meier analysis (the ability for the treated artery to remain open) was 95.8 percent, and freedom from target vessel revascularization (no repeat procedure) was 98.6 percent. Additionally, investigators evaluated patient quality of life using two common screening tools for peripheral vascular disease, an Ankle Brachial Index (ABI) and Walking Impairment Questionnaire (WIQ). The data from the trial demonstrated significant improvements in ABI and WIQ scores at both 30 days and nine months when compared to the baseline.
The EverFlex™ and Protégé™ GPS™ self-expanding stent systems are Nitinol
stent systems that expand to a predetermined diameter to restore blood
flow. The EverFlex™ stent, which received iliac
“The DURABILITY Iliac study further demonstrates how the EverFlex™
self-expanding peripheral stent system can improve blood flow, which may
help patients with iliac stenosis reduce pain, regain mobility and
improve healing,” said
*The Protégé GPS Self-Expanding Stent System is cleared in the U.S.
for biliary use and is currently not indicated for iliac stenosis. The
results of the DURABILITY Iliac trial have been submitted to the
The EverFlex™ Self-Expanding Peripheral Stent System is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameters of 4.5 – 7.5 mm.
Use of the EverFlex™ Self-Expanding Peripheral Stent System is contraindicated in patients with known hypersensitivity to nickel titanium; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
Potential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to: Allergic reaction, Amputation, Arterial dissection/perforation, Bleeding disorders (including GI, lymphatic), Infection (local or systemic including bacteremia or septicemia), Pseudoaneurysm, Restenosis, Stent/Vessel Thrombosis, Surgical or endovascular intervention.
See the Instructions for Use provided with the product for a complete list of warnings, precaution, adverse events and device information.
CAUTION: Federal (