Edwards SAPIEN Transcatheter Valve Trials
The move to minimally invasive procedures for heart valve surgery took another step forward last week when Edwards Lifesciences announced that the first set of patients were treated in a United States feasibility study using the Edwards SAPIEN transcatheter heart valve.
The Edwards SAPIEN valve is used for addressing congenital conditions (e.g. aortic stenosis and pulmonary stenosis). The study will enable physicians to offer a minimally invasive alternative to symptomatic patients with a failing pulmonary valve.
The company said the study of thirty patients at three hospitals would enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application. The U.S. Food and Drug Administration, or FDA, conditionally approved the investigational device exemption clinical trial in late 2007.
Edwards’ physician partners performed the first U.S. transcatheter pulmonic case on a compassionate basis in December 2005, all of which have been successful, the company noted.
The company added that Edwards SAPIEN transcatheter heart valve is also currently being studied in a pivotal trial for the treatment of patients with severe aortic heart valve stenosis, in which narrowing of the aortic valve restricts blood flow.
Keep on tickin!
Adam Pick is a double heart valve replacement patient and author of The Patient’s Guide To Heart Valve Surgery, a unique book which integrates the clinical facts of heart valve surgery with the personal experiences of an actual heart valve surgery patient.
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July 25th, 2008 at 12:06 pm
My son has Tetrology of Fallot. He had it repaired at 13 months of age and then had a homograph to replace his pulmonary valve at the age of 12. He is now 17 and his cardiologist says he will need it replaced within the next few years. I am very interested in any information you might be able to direct me to regarding the transcatheter replacement of this valve. We live in Arizona and I am not aware of where this procedure is available.
November 18th, 2008 at 12:34 pm
They are doing this procedure at Medical City Dallas Hospital, in Dallas, TX.