Edwards Lifesciences Corp (NYSE:EW) has announced that its Intuity Elite Valve system has received U.S. Food and Drug Administration (FDA) approval. This development comes only two years later after it had secured a CE mark for this device. Following the approval, Edwards has commercially launched the deployment of this device in the U.S. market.
Coronary artery disease has become a very common medical condition affecting millions worldwide. In fact, in the U.S., heart disease has become the leading cause of death for both women and men. Aortic valve replacement is a standard procedure used to treat these patients. It typically involves dangerous and risky open-heart surgery. As of today, minimally-invasive surgery is preferred as it involves less complications. Edwards’s Intuity Elite Valve system is one such device used for minimally invasive aortic valve replacement.
The FDA’s approval for Edwards’s Intuity Elite valve system was supported by data from the TRANSFORM clinical trial, which treated 839 patients across 29 centers in the U.S. The data on these trials showed that Edwards’ Intuity Valve system is safe and effective. It also may reduce cross-clamp time in a cardiopulmonary bypass. This might help lower time in an intensive care unit, decrease mortality and morbidity and reduce total hospital stay.
Since its launch in Europe two years ago, the Intuity Elite valve system has recorded a strong demand growth. The company is expected to see similar growth sales in the U.S. The management is also anticipating a meaningful contribution from the device towards Edwards’ overall growth sales in 2016. The global prosthetic heart valve market is expected to be worth $4.8 billion by 2020. Edwards is optimistic about capturing a larger share of this market.