No new concerns raised by USFDA staff about Abbott heart device
The U.S. Food and Drug Administration (FDA) staff reviewers did not raise any new concerns over the safety and effectiveness of Abbott’s heart valve repair device designed for patients who are at risk for surgery.
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.
About 1.6 million Americans are estimated to have the disorder, according to government data.
The FDA, however, noted that there was no signal of reduced deaths or hospitalizations in patients who received the implant compared to those who were on medical therapy.
“With limited alternatives, we think this alone should be enough to drive approval and adoption despite the lack of a mortality or hospitalization benefit, which the overall tone and substance of the briefing documents are supportive of as well,” J.P.Morgan analyst Robbie Marcus wrote in a note.
The device, already approved in more than 50 countries, is inserted through the femoral vein in the leg and is then guided and clipped on to the tricuspid valve.
The FDA had approved a similar device from rival Edwards Lifesciences earlier this month to treat patients with TR.
Abbott’s application is based on data from a late-stage study in which TriClip was shown to significantly improve patients’ quality of life.
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