Medtronic (MDT) recently announced the initiation of IN.PACT SFA II study to evaluate the safety and efficacy of its Admiral drug-eluting balloon in the treatment of peripheral artery disease (“PAD”) in the superficial femoral artery and/or proximal popliteal artery. Successful commercialization of the device can be of immense help to a large patient base as estimates put the number of afflicted people in the US alone to almost 8-12 million.
The IN.PACT SFA II study will involve several patients across 55 sites in the US, who will be randomized 2:1 to be treated with either Medtronic’s IN.PACT Admiral drug-eluting balloon or a traditional non-coated angioplasty balloon.
The company plans to combine data from IN.PACT SFA II with IN.PACT SFA I study (currently underway in Europe) to support a premarket approval (“PMA”) application to the US Food and Drug Administration (‘FDA’). Approximately 450 patients will be enrolled in the two studies.
Medtronic has big plans for its global IN.PACT clinical program that will encompass 24 studies with approximately 4,000 patients across more than 80 countries worldwide. Of these, 7 have completed enrollment while 10 have begun enrollment.
Medtronic is working on expanding its portfolio particularly in emerging therapies. This strategy is significant for the company as it is witnessing several headwinds in its core segments.
The challenges are rife across the MedTech space with the company’s peers, Boston Scientific (BSX) and St Jude Medical (STJ), facing a similar situation. Acknowledging the challenges at play, Medtronic is in the process of launching several new products that are likely to drive growth in this difficult scenario.
Among the recently launched products, the Revo MRI pacemaker created a stir in the pacing business, registering 4 points of market share gains in the US in the last reported quarter. Other products with potential include the Symplicity catheter system for renal denervation, Core Valve (US launch scheduled for fiscal 2014), the RestoreSensor spinal cord stimulator and the Enlite continuous glucose monitoring sensor.
We have a Neutral recommendation on Medtronic. The stock retains a Zacks #3 Rank (Hold) in the short term.
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