Leading medical devices player Medtronic (MDT) has received CE Mark approval for its 31mm CoreValve system.
The company’s CoreValve portfolio currently has three types of valves: 26 mm, 29 mm and 31 mm. Following the recent approval, Medtronic will be able to treat a larger patient population suffering from severe aortic stenosis.
Medtronic’s CoreValve system takes a minimally invasive route to treat patients with symptomatic, severe aortic stenosis, who are at high risk or are ineligible for open-heart surgery. Globally, about 300,000 people have been diagnosed with this condition of which one-third is deemed too risky for open-heart surgery. The CoreValve system has been implanted in more than 15,000 people in more than 40 countries since 2007. However, the device is yet to receive approval in the US.
Medtronic’s CardioVascular segment recorded revenues of $879 million during the last reported quarter, up 16% year over year driven by growth from Coronary & Peripheral (up 15% at $440 million), Structural Heart (up 15% at $274 million) and Endovascular (21% at $165 million). Revenue growth was driven by strong international performance (15% growth), particularly in emerging markets.
The robust growth in Structural Heart was driven by strong adoption of CoreValve in the international markets and the acquisition of ATS Medical, which contributed 800 bps to this division’s growth. Enrollment is currently ongoing in the US pivotal trial of the CoreValve system.
With disappointing performance at its two core segments of CRDM and Spinal over the past few quarters, Medtronic has turned its attention to other emerging therapies to drive its top line. Approval of the CoreValve in the US should enable the company to record higher revenues from this segment going forward.
However, Medtronic faces tough competition in this field from Edwards Lifesciences (EW). Moreover, Boston Scientific (BSX) has acquired Sadra Medical, which develops percutaneous aortic valves replacement to treat patients with severe aortic stenosis. While Edwards expects US approval of its Sapien transcatheter heart valve in 2011, Boston Scientific plans to begin the CE Mark trial of its Lotus valve in the fourth quarter of 2011.
