The US Food and Drug Administration (FDA) has granted humanitarian device exemption for an implantable replacement heart in patients with end-stage biventricular heart failure who are not eligible for other treatment options; approval for an artificial intervertebral disc in the treatment of low back pain in patients who have no more than grade 1 spondylolisthesis and who have failed at least 6 months of conservative treatment; and approval for a diagnostic/ablation deflectable tip catheter in the treatment of adults with recurrent refractory sustained monomorphic ventricular tachycardia.
The device manufacturers are, as expected, quite pleased.
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