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Tuesday, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA confirmed 13 to 1, with 0 abstention, that the benefits of Abbott Laboratories (NYSE:ABT) TriClip transcatheter edge-to-edge repair (TEER) system outweighed the risks to treat tricuspid regurgitation (TR).
After reviewing data from Abbott’s TRILUMINATE pivotal trial and listening to testimony, the panel voted on the device’s safety, effectiveness, and risk/benefit profile as a treatment for TR.
On whether there is enough data to support the device’s safety, the vote was 14 to 0 in favor. On the separate question of whether there is reasonable assurance that the device is effective, the vote was 12 to 2 in favor.
On the final question of the benefit of TriClip versus the risk, the vote was 13 to 1 in favor.
The panel’s vote will be considered by the FDA when deciding to approve TriClip, a first-of-its-kind minimally invasive device specifically designed to treat the difficult-to-access tricuspid valve.
The tricuspid valve controls blood as it flows from the heart’s right atrium to the right ventricle.
TR occurs when the valve doesn’t close properly, causing a leak and allowing blood to flow backward in the heart.
Delivered through a vein in the leg, TriClip’s TEER technology works by clipping together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without needing open-heart surgery.
Abbott submitted its pre-market approval application for the TriClip device to the FDA in March 2023.
The FDA’s decision on Abbott’s TriClip is expected in 2024.
TriClip is approved for use in more than 50 countries, including in Europe and Canada, and has already been used to treat more than 10,000 people with TR. It is an investigational device in the United States.
In addition to TriClip, the company’s minimally invasive therapies include first-of-its-kind technologies MitraClip (to treat leaky valves in people with mitral regurgitation) and Amplatzer Piccolo Occluder (to close a hole in the heart of babies), as well as the Navitor transcatheter aortic valve implantation system (to treat aortic stenosis).
Price Action: ABT shares are up 0.18% at $111.54 on the last check Wednesday.
Photo via Company
27% profits every 20 days?
This is what Nic Chahine averages with his options buys. Not selling covered calls or spreads... BUYING options. Most traders don't even have a winning percentage of 27% buying options. He has an 83% win rate. Here's how he does it.
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