Abbott Shines Light on “Forgotten Valve” with New Pivotal Trial
Abbott Laboratoriesâ latest pivotal trial will have the company taking a deeper dive into the treatment of what has been dubbed by some as the âforgotten valve.â
The Abbott Park, IL-based has launched an IDE study of the TriClip, a transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR).
The TRILUMINATE Pivotal trial will evaluate a catheter-based, non-surgical treatment for patients with severe TR â a condition in which the valve doesn't close properly, allowing blood to flow backward into the heart, which forces the heart to work harder.
Abbott's IDE study is set to enroll 700 patients in centers in the U.S., Canada, and Europe. Patients in the trial will be randomized to receive either the TriClip device or medical therapy and followed for a total of five years. The study will also have a single arm for the treatment of subjects with more complex tricuspid valve disease.
TriClip was also accepted for national reimbursement consideration through a process known as "Parallel Review" by FDA and the Centers for Medicare and Medicaid Services.
There is data from an 85-patient trial with sites in the U.S. and Europe that show TriClipâs effectiveness. Results from this trial were revealed during EuroPCR 2019 in May. The results show that after 30 days, 86.6% of patients who received the TriClip device saw a reduction in TR severity of at least one...
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
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