Aortic Valve Devices Are Changing Heart Surgery Landscape

These are the latest findings of GlobalData (London, United Kingdom), an international business intelligence provider.

The percutaneous treatment of severe aortic valve disease (AVD) using a TAVR prosthetic aortic valve replacement, without the need for open-heart surgery or cardiopulmonary bypass, is faster and less invasive than current open-heart procedures. TAVR has so far been proven effective in high-risk and inoperable patients, and could soon become the standard of care, even in moderate and low surgical risk patients. This is dependent, however, on the development of devices with reduced paravalvular regurgitation and the reduction of the high incidence of stroke associated with TAVR, two challenges that have plagued first-generation devices.

Companies such as Direct Flow Medical and AorTech International (Rogers, MN, USA) are currently working to develop second-generation devices with prosthetic valve leaflets made of synthetic polymers to improve durability and reduce costs, while ValveXchange (Greenwood Village, CO, USA) has developed a TAVR system whose exchangeable leaflets can be replaced as they wear out. Physicians have also called for improved repositionability and reduced delivery sheath sizes. With more companies entering the market, and increasingly larger numbers of patients suitable for TAVR treatment, these points of difference between products are predicted to drive sales.

Germany currently leads the way with TAVR procedures, but other European countries are not far behind, and the US is quickly catching up. On the other hand, the technology has barely begun to penetrate the Asian, South American, Australian, and South African markets. Clinical trials are beginning in Japan, a few heart centers in Singapore are starting to use TAVR devices, and South America has given approval to one TAVR company to launch their product. GlobalData expects that most major heart centers in the US and Europe will offer the procedure in coming years, and forecasts the TAVR global market will reach USD 2.6 billion by 2018.

“Aortic valve disease affects over 3.6% of the population older than 65, and severe cases of it have mortality rates of nearly 50% at two years,” said GlobalData analyst Rob Littlefield, MSc. “However, even after 45 years of refinement, surgical techniques fail to provide suitable options for AVD patients who are inoperable due to comorbidities. Since its first in-human use in 2002, TAVR has created a wholly new market targeted at this inoperable crowd.”

Related Links:
GlobalData
AorTech International
ValveXchange