Medtronic, Inc. MDT, today announced
completion of enrollment in IN.PACT SFA II, the U.S. arm of its clinical study
for the IN.PACT Admiral drug-eluting balloon as a treatment for peripheral
artery disease in the superficial femoral and proximal popliteal arteries (SFA
and PPA).
IN.PACT SFA II is a prospective, multicenter, randomized controlled trial that
enrolled 181 patients at more than 40 U.S. sites and randomized them 2:1 to
treatment with either the IN.PACT Admiral drug-eluting balloon (study arm) or
a traditional, non-coated angioplasty balloon (control arm). Its primary
efficacy endpoint is primary patency, a measure of blood flow through the
treated arterial segment, at 12 months.
The principal investigators of IN.PACT SFA II are interventional cardiologist
Dr. John Laird, professor of medicine at the University of California Davis
and medical director of the UC Davis Vascular Center, and vascular surgeon Dr.
Peter Schneider, chief of the vascular therapy division at Kaiser Foundation
Hospital and Hawaii Permanente Medical Group in Honolulu.
Results of IN.PACT SFA II will be combined with those from IN.PACT SFA I,
which previously completed enrollment of 150 patients in Europe, to support a
premarket approval (PMA) application to the U.S. Food and Drug Administration
(FDA).
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in