Valve trial gets a boost
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences gets conditional FDA approval to enroll patients receiving its Sapien transcather heart valve by an alternative delivery technique in its ongoing PARTNER trial evaluating the less invasive valve against open-heart valve surgery and medical management. The firm had already announced in December a verbal agreement with the agency to begin enrolling patients getting the device by the "transapical" approach via the rib cage in addition to the initially approved "retroflex" delivery through the leg arties (1"The Gray Sheet" Dec. 17, 2007, p. 10). Trial investigators have cited the limitations on delivery technique as a major factor in enrollment delays. Edwards also received conditional approval to enroll an additional 440 patients for a total of 1,040, the firm said Jan. 29