) has further strengthened its endovascular business. Recently,
this leading medical devices company completed the enrollment in
its multicenter, randomized controlled trial IN.PACT SFA II, the
U.S. division of its clinical study for the IN.PACT Admiral
drug-eluting balloon. According to the company, successful
completion of the study will prove this drug-eluting balloon
useful in treating peripheral artery disease in the superficial
femoral and proximal popliteal arteries (SFA and PPA).
The IN.PACT SFA II trial enrolled 181 patients across 40 U.S.
sites and randomized them 2:1 to treat with either the IN.PACT
Admiral drug-eluting balloon (study arm) or a traditional,
non-coated angioplasty balloon (control arm). The study results
will be combined with the same from IN.PACT SFA I to support a
premarket approval ("PMA") application to the U.S. Food and Drug
IN.PACT SFA I already completed the enrollment of 150 patients
in Europe. In the meantime, European studies results involving
IN.PACT drug-eluting balloons continue to be reported.
Medtronic's IN.PACT Admiral drug-eluting balloon has become
another platform for cardiovascular interventions besides
traditional balloon angioplasty, bare-metal stents and
drug-eluting stents ("DES").
Medtronic's Cardiac and Vascular segment, accounting for a
total of 53% of revenues, offers minimally invasive products and
therapies for the treatment of atrial fibrillation, information
systems for the management of patients with CRDM devices,
coronary and peripheral stents and related delivery systems,
therapies for uncontrolled hypertension, endovascular stent graft
systems, heart valve replacement technologies, cardiac tissue
ablation systems, open heart and coronary bypass grafting
surgical products. We believe that the successful
commercialization of this drug-eluting balloon in the U.S. will
drive revenue growth of this segment going ahead.
We are encouraged by Medtronic's focus on portfolio expansion
along with its aim to boost revenues from the emerging markets.
Meanwhile, Medtronic continues to target returning 50% of the
free cash flow to shareholders. However, unfavorable currency and
macroeconomic uncertainty in Southern Europe adversely affected
sales. These headwinds have also adversely affected the company's
Medtronic retains a Zacks Rank #3 (Hold). Some of the Zacks
Rank #1 (Strong Buy) stocks are
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