Medtronic Ends SFA II Enrollment - Analyst Blog
Medtronic Inc. ( MDT ) 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 Administration ("FDA").
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 peers like Boston Scientific ( BSX ).
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