The AP (9/24) reports the
Sapien heart valve “is approved for patients who face major risks from
open-heart surgery or who are too sick to have that procedure done.” The
original labeling on the device “instructed surgeons to thread the valve into
place through a major artery that runs from the leg up to the heart.” Under the
new approved labeling, that language is removed, “allowing surgeons to choose
from multiple methods of implantation.”
Forbes (9/24, 6.03M)
contributor Larry Husten writes that “the most significant part of the FDA’s
announcement may be not the label change itself but the source of the data
supporting the claim, the Transcatheter Valve Therapy Registry (TVTR).” This
registry, “which is run by the American College of Cardiology and the Society
of Thoracic Surgeons, has emerged as an model of cooperation between the FDA,
industry, and medical organizations.” In a press release, director of the FDA
Center for Devices and Radiological Health, Jeffrey Shuren said, “Leveraging
clinical research inside the framework of a device registry to expand access to
therapy for more patients is a new paradigm for the FDA, researchers, registry
sponsors and the medical device industry.”
POSTED BY: Steven
Almany M.D.
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