New TAVR device on the market as Abbott’s Navitor system receives CE mark - Verdict Medical Devices
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New TAVR device on the market as Abbott’s Navitor system receives CE mark

By GlobalData Healthcare 19 May 2021 (Last Updated May 19th, 2021 17:12)

Abbott Laboratories' new transcatheter aortic valve replacement (TAVR) system, Navitor, recently received regulatory approval in Europe.

On 17 May, Abbott Laboratories announced that its new transcatheter aortic valve replacement (TAVR) system, Navitor, had received regulatory CE mark approval in Europe. The Navitor is currently indicated for the treatment of severe aortic stenosis in those at high or extreme risk for surgery.

Before the Covid-19 pandemic, the TAVR market was experiencing a high, double-digit compound annual growth rate (CAGR). In the US alone, the TAVR market value rose at a CAGR of almost 30% from 2018 to 2019, reaching sales of just over $2bn in 2019. While the pandemic has negatively impacted this market, the impact was far less severe than that on markets for other devices, indicating strong enthusiasm for the TAVR procedure even during the pandemic.

Growth in the TAVR market has been driven largely by physicians’ preference for minimally invasive procedures compared to open surgery, when possible, and expanding device indications. In the past, TAVR devices were only indicated to treat patients with severe aortic stenosis at high or extreme risk for surgery, but device indications have expanded to include treatment of patients at both intermediate and low risk. With each indication expansion, a greater pool of patients has become available for treatment with TAVR, allowing the market to continue to grow.

Multiple factors have inhibited growth in the TAVR market. Certain complications have been documented more in patients receiving the treatment than in patients receiving surgical valve interventions. For example, paravalvular leakage (PVL), in which blood leaks around the implanted valve, compromising the valve’s effectiveness, has been found to occur in some TAVR patients after implantation. If physicians are concerned that specific patients are at risk of PVL, they may be persuaded to use surgical means for valve implantation rather than TAVR.

The impact of Abbott’s Navitor on the TAVR market will depend on multiple factors. One factor that will likely help the Navitor is its unique design. Abbott has reported that the Navitor features a unique fabric cuff that reduces or eliminates PVL. If this is true, it would encourage physicians to choose the Navitor over other competitor devices if they have patients at risk for PVL. As well as this, Abbott commands a strong brand presence in the transcatheter valve space, as it is currently the market leader in transcatheter mitral valve repair with its MitraClip device.

The Navitor, however, is currently only indicated for patients at high or extreme risk for surgery. This limited indication places the Navitor behind other market competitors such as Medtronic’s Evolut or Edwards Lifesciences’ Sapien, both of which have much wider indications. Since the Navitor is currently not an option for treating patients at intermediate or low surgical risk, physicians would choose alternative devices for these patients.

On the whole, due to the benefits that the Navitor offers patients at risk of PVL and Abbott’s brand strength in this area, the device will likely gain market share quickly in Europe.

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