News from the FDA/CDC

FDA approves first dedicated bifurcation device to treat coronary bifurcation lesions


 

Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.

In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.

It is noted that the confirmatory study met its pre-specified primary endpoint, periprocedural myocardial infarction, which was within its noninferiority margin (primary endpoint, P = .01).

“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”

There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.

Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.

Read more on Tryton Side Branch Stent on Tryton’s website.

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