Stent grafts used for repairing thoracoabdominal aortic aneurysms (TAAA) are typically designed to mimic the patient's anatomy, but a new device being evaluated in an early feasibility study bucked that tradition and one of the lead investigators told Medical Device Daily that just may make all the difference. TAAAs start at the chest and extend through the abdomen and represent about 15 percent of thoracic aneurysms.

The CMS has rendered a final coverage decision for left atrial appendage devices, a move driven largely by the successful Watchman PMA by Boston Scientific, which slogged through three FDA advisory committee hearings on its way to the CMS coverage analysis. The final decision memo included several important changes compared to the draft, including that the agency has dropped the demand for a contemporaneous set of patients on medical therapy, making the resulting study a simpler and less expensive one-arm registry study.