The assessment comes ahead of the FDA's independent expert panel meeting on Tuesday, which will make recommendations on whether or not to clear the use of the device, TriClip, in patients with tricuspid regurgitation (TR). TR is a disorder in which the tricuspid valve that separates the right lower heart chamber from the right upper heart chamber does not close tight enough, potentially causing heart failure.
(Reuters) -The U.S. Food and Drug Administration's staff reviewers on Friday asked the regulator's advisory panel to consider the need for additional studies for Vertex Pharmaceuticals and CRISPR Therapeutics' sickle cell disease gene therapy. The therapy, called exagamglogene autotemcel or exa-cel, uses new gene editing CRISPR technology, and is the first-of-its-kind product to reach the FDA for an approval decision.