MINNEAPOLIS–(BUSINESS WIRE)–Consistent with its
commitment to developing better treatments for peripheral arterial disease
(PAD), Medtronic Inc. today announced the one-year results of an international
study of the Complete SE (self-expanding) vascular stent for the treatment of
atherosclerosis in the superficial femoral artery (SFA). The device is
investigational in the United
As presented for the first time at ISET and LINC in January,
the Complete SE SFA study demonstrated a primary patency rate of 73.1 percent,
a major adverse event rate of 11.0 percent and a target lesion revascularization
(TLR) rate of 9.4 percent at 12 months of patient follow-up. The TLR rate, a
patient-centric measure of symptom-driven reintervention, means that more than
90 percent of study subjects at the one-year time-point had not required
another procedure to treat the target lesion.
The Complete SE SFA study was a prospective, single-arm
trial that enrolled 196 subjects (with a total of 213 lesions) at 28 sites in
the United States and Europe.
Approved by the U.S. Food and Drug Administration (FDA)
under an investigational device exemption (IDE), the study evaluated the safety
and efficacy of the Complete SE stent in treating lesions of the SFA, including
the proximal popliteal artery (PPA), with the primary endpoints assessed at 12
months: major adverse events for safety and primary patency for efficacy. All
study subjects were determined to have symptomatic, ischemic PAD involving the
The principal investigators of the study are Dr. John Laird
of UC Davis Medical Center in the United States
and Prof. Dr. Dierk Scheinert of the University of Leipzig Heart Center in Germany.
“The strong performance of the Complete SE vascular stent in
this rigorously conducted clinical trial is encouraging,” said Dr. Laird, who
presented the results at this years International Symposium on Endovascular
Therapy (ISET) in Miami and the Leipzig
Interventional Course (LINC) in Germany.
“The investigators found the device easy to use in treating SFA lesions of
varying complexity, which is indicative of clinical practice.”
Study subjects showed statistically significant improvements
in all measures of clinical and functional effectiveness, such as Rutherford
Category, mean ABI/TBI, and Walking Assessment. These improvements were
achieved despite the enrollment of patients with moderately or severely
calcified lesions (91.0%), diabetes (45.4%), and a Rutherford Category rating
of 3 or higher (66.8%) at baseline.
More than 80 percent of study subjects had achieved a
Rutherford Category value of 0 or 1, the favorable end of the 0–6 scale, at 30
days, and that benefit persisted through six months and one year of follow-up.
Treatment with the Complete SE stent also resulted in highly significant
positive shifts in mean ABI/TBI scores at six and 12 months, with more than 60
percent of study subjects improving by at least 0.15 over the follow-up period.
On Walking Assessment measures, impairment improved by 36.8 percent, distance
by 32.4 percent, speed by 21.8 percent and stair climbing by 23.3 percent.
The Complete SE stent, which is commercially approved by the
FDA for use in the iliac arteries, is Medtronics flagship self-expanding
peripheral vascular stent, known for its innovative delivery system that
enables exceptional deployment accuracy. Medtronic also plans to seek FDA
approval for the SFA indication.
“Our commitment to building the clinical evidence to advance
peripheral interventional therapies takes many forms,” said Tony Semedo, vice
president and general manager of the Endovascular Therapies business at Medtronic.
“The Complete SE SFA study is a prime example. We are also devoting significant
resources to building a strong clinical foundation for the use of drug-eluting
balloon technology to treat atherosclerosis in the lower extremities.”
The superficial femoral artery (SFA) runs under the skin of
the upper leg and carries blood to the lower extremities, from the thigh to the
toes. In patients whose SFA narrows (usually due to the accumulation along the
inner wall of the artery of fatty deposits called plaque), the flow of
oxygenated blood to the lower extremities becomes restricted, with consequences
ranging from leg pain while walking (claudication) to limb loss (amputation).
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical
technology –– alleviating pain, restoring health and extending life for
millions of people around the world.