Tryton Medical Receives FDA Approval for Tryton Side Branch Stent

March 6, 2017—Tryton Medical, Inc. announced that the US Food and Drug Administration (FDA) has approved the company’s premarket approval application for the Tryton side branch stent in the treatment of coronary bifurcation lesions involving large side branches (appropriate for a ≥ 2.5-mm stent). The Tryton side branch stent is available in multiple device diameters (2.5–3.5 mm in the side branch) and is compatible with any conventional drug-eluting stent in the main vessel.

Tryton advised that it has signed a strategic distribution agreement under which Cordis, the interventional vascular business of Cardinal Health, will be the exclusive distributor of the Tryton side branch stent in the United States. The device has been commercially available in multiple countries within Europe, the Middle East, and Africa. It is not available in Japan.

According to the company, a post hoc analysis of a randomized investigational device exemption (IDE) clinical trial demonstrated that treatment with the Tryton side branch stent in the intended population of patients with large side branches reduced the need for additional bailout stenting (0.7% vs 5.6%; P = .02) and led to statistically significant lower side branch percent diameter stenosis at 9-month follow-up (30.4% vs 40.6%; P = .004) when compared to provisional stenting. The post hoc analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates versus provisional stenting at 3 years.

The safety profile of the Tryton side branch stent was validated in a confirmatory study that compared patients treated with the Tryton device to a performance goal based on performance of the control arm from the randomized IDE clinical trial. The confirmatory study met its prespecified primary endpoint, periprocedural myocardial infarction, which was within its noninferiority margin (primary endpoint, 10.5% + 95% confidence interval vs 17.9%; P = .01).

In Tryton's announcement, Aaron Kaplan, MD, commented, “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. 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.” Dr. Kaplan, who serves as Chief Medical Officer of Tryton Medical, is Professor of Medicine at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire.