Cordis Corporation Announces Two-Year Results from the STROLL Trial

  Cordis Corporation Announces Two-Year Results from the STROLL Trial

   Trial Assesses the Safety and Efficacy of the S.M.A.R.T.® Vascular Stent
                  Systems in the Superficial Femoral Artery

Business Wire

BRIDGEWATER, N.J. -- January 21, 2013

Cordis Corporation today announced the presentation of the two-year STROLL
study results at the Abstracts and Late Breaking Clinical Trials session at
ISET 2013.

William A. Gray, MD, Director of Endovascular Services, Cardiovascular
Research Foundation, New York, presented the results of the STROLL study
(S.M.A.R.T.® Vascular Stent Systems in the TReatment of Obstructive
SuperficiaL FemoraL Artery Disease) on behalf of the study investigators. The
STROLL study assessed the safety and efficacy of the S.M.A.R.T.® Vascular
Stent Systems (S.M.A.R.T.® Stent) in treating patients with obstructive
superficial femoral artery (SFA) disease.

"The two-year data from the pivotal STROLL trial highlight not only the
durability of the clinical outcomes such as patency and target lesion
revascularization using the S.M.A.R.T.^® Stent in the femoro-popliteal
vessels, but also the associated patient outcomes such as Rutherford
classification,” said Dr. Gray.

In the study, the average lesion length was 77 mm, 23.6% of patients presented
with total occlusions and 47% of patients were diabetic. Freedom from
clinically driven target lesion revascularization (TLR) at two years was
80.3%. The 24-month primary patency rate for the S.M.A.R.T.® Stent was 74.9%
by Kaplan Meier estimate. The primary duplex patency rate (PSVR>/=2.5) was
83.5%. There were no major adverse events at 30 days after the initial index
procedure. There was also a low rate of stent fractures noted at 12 months
(2.0%) with no additional fractures reported out to 24 months. All stent
fractures were Type I, least severe, and there were no incidents of more
severe stent fractures (Type II-V).

In addition to the excellent clinical outcomes in the STROLL study, the
clinical data showed an improvement in patient outcomes. This included minimal
or no signs of PAD* in more than 80% of patients (as measured using
Rutherford-Becker classification), and normal Ankle Brachial Index (ABI) in 4
of 5 patients at 2 years. ^ 1

“The exceptional two-year results in the STROLL Study confirm the long-term
efficacy of the S.M.A.R.T.® Vascular Stent Systems in the treatment of
Peripheral Arterial Disease (PAD),” said Shlomi Nachman, Worldwide President,
Cordis Corporation. “Beyond the clinical results, the excellent patient
outcomes observed at one year were sustained through the second year. The
unique design of the S.M.A.R.T.® Vascular Stent contributed to these results
and we look forward to continuing to build on its legacy.”

STROLL is a multicenter, non-randomized, single-arm, prospective trial
comparing the safety and efficacy of the S.M.A.R.T.® Stent with a previously
published objective performance goal. Patients ≥30 years of age with de novo
or restenotic native SFA lesion(s) or total occlusions with length ≥ 4.0 cm to
≤ 15.0 cm, and reference vessel diameters of ≥ 4.0 mm to ≤ 6.0 mm were
included in the study. The 12-month primary patency endpoint was defined as no
relevant flow reduction by duplex ultrasonography (DUS) determined by
independent core lab, and no interim clinically driven TLR. The primary safety
endpoint was 30-day freedom from major adverse events, a composite of
all-cause death, index limb amputation and clinically driven TLR. Secondary
endpoints cover a variety of morphological, clinical and hemodynamic outcomes.
The STROLL Study will follow patients out to three years with mandatory X-Ray
and DUS at all key follow-up points.

The STROLL study represents the latest commitment by Cordis to continue its
groundbreaking work in the fight against vascular disease. Late last year, the
U.S. Food and Drug Administration (FDA) approved the S.M.A.R.T.® CONTROL®
Vascular Stent Systems for use in the superficial femoral artery (SFA) and/or
the proximal popliteal artery (PPA). The S.M.A.R.T.® Stent, which has been
approved for peripheral indication in international markets since 1999, is now
the first stent in the United States with both Iliac and SFA indications.

Dr. Gray is compensated for his services as a member of the company’s
scientific advisory board and provides other consulting services.

About Cordis Corporation

Cordis Corporation, part of the Johnson & Johnson family of companies, is a
worldwide leader in the development and manufacture of interventional vascular
technology. Through the company's innovation, research and development, Cordis
partners with interventional cardiologists worldwide to treat millions of
patients who suffer from vascular disease. More information about Cordis
Corporation can be found at www.cordis.com.

*Defined as Rutherford-Becker classification 0 or 1.

Reference: 1. Data on file, Cordis Corporation.

Contact:

Cordis Corporation
Janet Kim
(o) 909-839-7275
(m) 213-215 5737
jkim50@its.jnj.com
or
Sandy Pound
(o) 908-218-2720
(m) 908-432-2829
Spound@its.jnj.com
 
Press spacebar to pause and continue. Press esc to stop.