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. [1] 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 [2] severe aortic heart valve stenosis, in which narrowing of the aortic valve restricts blood flow.

Keep on tickin!

[3] 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.