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US-based Medtronic has received the US Food and Drug Administration (FDA) approval for its self-expanding transcatheter CoreValve system, designed for severe aortic stenosis patients who are too ill or frail to undergo aortic valve replacement through traditional open-heart surgery.

The FDA approved the CoreValve device based on a US pivotal trial in which it was shown to be safe and effective while demonstrating low rates of stroke and valve leakage.

In the trial, the CoreValve System also achieved exceptional haemodynamics, or blood flow, post-implant with results similar to the gold-standard surgical valves, the company reported.

In addition to this, valve leakage (known as paravalvular leak or PVL) rates were low and decreased over time as the self-expanding valve conformed to the shape of a patient’s annulus – an improvement that has not been reported in other major TAVR studies.

The extreme risk study met its primary endpoint of death or major stroke at one year with a rate of 25.5%, which was 40.7% lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA).

At one month, the rate of stroke was 2.4%, and it remained low over time with a one-year rate of 4.1%.

Additionally, 75.6% of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the US pivotal Trial, demonstrated even better survival and stroke performance.

The CoreValve System was developed to serve the needs of the broadest range of patients with severe aortic stenosis.

The FDA approved the entire CoreValve platform including the CoreValve Evolut 23mm, and the CoreValve 26mm, 29mm and 31mm valves.

"The FDA approved the CoreValve device based on a US pivotal trial in which it was shown to be safe and effective while demonstrating low rates of stroke and valve leakage."

The CoreValve System is suitable for patients with native valves of nearly all sizes and its self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.

All valve sizes are delivered through the smallest (18Fr, or 6mm) TAVR delivery system available, making it possible to treat patients with difficult or small vasculature.

Medtronic senior vice-president and president of the Medtronic Structural Heart Business Dr John Liddicoat said, "The FDA approval of CoreValve System is important for US heart teams as the CoreValve System will serve the broadest spectrum of aortic stenosis patients who are unable to undergo surgery."

The CoreValve System, which received the CE mark approval in 2007 has been implanted in more than 50,000 patients worldwide, excluding the US.

For the High Risk Study of the CoreValve US Pivotal Trial, which is comparing the CoreValve System to traditional open heart surgery, the FDA determined it will conduct a separate review of the data.

According to GlobalData estimates, the transcatheter heart valves market in the US was valued at $280m in 2012 and is expected to grow at a CAGR of 25.3% to reach $1.36bn by 2019.

Image: Medtronic world headquarters, Minneapolis, US. Photo: courtesy Medtronic.