New aortic valve devices may hold the key to your heart

LONDON -- Open heart surgery may be a dying art, as new valve replacement techniques offer life-changing treatment without the need for invasive procedures, states a new report by healthcare experts GlobalData.

The new report* studies Transcatheter Aortic Valve Replacement (TAVR), which allows the percutaneous treatment of severe Aortic Valve Disease (AVD) through the implantation of a prosthetic aortic valve within the diseased native valve without the need for open heart surgery or cardiopulmonary bypass.

Rob Littlefield, MSc., GlobalData’s analyst for cardiovascular devices, states: "AVD affects over 3.6% of the population older than 65, and severe cases of it have mortality rates of nearly 50% at two years. 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.”

The first and second TAVR devices ever approved received CE Mark in Europe in 2007, followed by four others since then. Only one device has FDA approval in the US, which it received in 2011, but the market has been developing quickly as a result of the rapid adoption of the procedure in these regions. Littlefield says that TAVR is "faster than current open-heart procedures, less invasive, and the results have been positive thus far." TAVR devices are already evolving as companies work to further improve this technology, with many second-generation valves approved in Europe, and others due to launch on the continent and in the US in the near future.

TAVR has been proven effective in high-risk and inoperable patients, but there is still plenty of room for improvement before TAVR becomes the standard of care and is used on moderate and low surgical risk patients; however, these patients represent a large future market. Companies with new devices in development are aiming to reduce paravalvular regurgitation and the high incidence of stroke associated with TAVR, two challenges that have plagued first-generation devices. Further evidence of safety and efficacy will help TAVR be approved for these lower-risk patient pools.

Direct Flow Medical and AorTech International are currently working to develop devices with prosthetic valve leaflets made of synthetic polymers to improve durability and reduce costs, while ValveXchange has developed a TAVR system whose exchangeable leaflets can be replaced as they wear out. PhysAir Jordan Shoes Men