Patients Receive Heart Valve Replacements Without Surgery Using High-Tech Device

[kashyap putra]

Patients Receive Heart Valve Replacements Without Surgery Using High-Tech Device Interventional
 
Rush is one of three sites taking part in the investigational device exemption (IDE) feasibility study of minimally-invasive pulmonic valves and successfully implanted the first three patients enrolled in the trial on April 17.


 
Edwards Lifesciences Corporation of Irvine, Calif., makes the Edwards SAPIEN transcatheter valve that was implanted.
 
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007.  The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application.

Source: sciencedaily.com Aeva Debug: 0.0145 seconds.