The syndrome of idiopathic normal pressure hydrocephalus (INPH) is characterized by ventriculomegaly in the absence of raised intracranial pressure and presents as the clinical triad of gait ...
An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.
The outside advisors analyzed the results of the RELIEVE-HF pivotal trial, which randomized 508 patients to either receive ...
J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions. Following the vote, a J&J spokesperson ...
The FDA’s Circulatory System Devices Panel voted not to recommend approving use of an interatrial shunt to improve heart failure symptoms and prognosis.In a 0-15 vote, the committee determined risk ...
Brian Fahey explains how Adona Medical uses heat to adjust its novel shape memory nitinol implant without harming heart ...