FDA Approves Abbott's Heart Valve Repair Device For Patients At Risk Of Complications/Death During Open-Heart Surgeries
Portfolio Pulse from Vandana Singh
The FDA has approved Abbott Laboratories' TriClip, a transcatheter edge-to-edge repair system designed for treating tricuspid regurgitation (TR) without the need for open-heart surgery. This approval is based on the TRILUMINATE Pivotal trial, which showed that 90% of patients experienced significant improvement in their TR grade, with a highly favorable safety profile. TriClip, leveraging technology similar to Abbott's MitraClip, is expected to see high sales growth and has been approved in over 50 countries, treating over 10,000 people.

April 02, 2024 | 5:00 pm
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POSITIVE IMPACT
Abbott Laboratories receives FDA approval for its TriClip device, designed to treat tricuspid regurgitation non-surgically. The device has shown significant patient improvement and safety, expected to contribute to high sales growth.
The FDA approval of Abbott's TriClip device is a significant milestone for the company, indicating a strong potential for market expansion and revenue growth. Given the device's demonstrated effectiveness and safety, along with its inclusion in Abbott's 'Fab 5' devices expected to drive sales, the approval is likely to have a positive short-term impact on Abbott's stock price. The device's ability to treat tricuspid regurgitation non-surgically addresses a significant unmet medical need, potentially leading to widespread adoption and increased sales.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100