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Tryton Medical announced Monday that its Tryton Side Branch Stent gained FDA approval for the treatment of coronary bifurcation lesions involving large side branches, which are appropriate for a 2.5mm or larger stent. According to the company, the device "is the first dedicated bifurcation device to receive regulatory approval in the US."
CEO Shawn McCarthy remarked that "cardiologists now have access to a stent that is specifically engineered to provide the complete lesion coverage and more predictable patient outcomes needed for the challenging anatomy of coronary bifurcation lesions." Meanwhile, Aaron Kaplan, chief medical officer, said that the approval "could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead."
Tryton Medical noted that the pre-market approval application for the stent was supported by a post hoc analysis of an investigational device exemption (IDE) trial and showed that the device reduced the need for additional bailout stenting and led to lower side branch percent diameter stenosis at nine months versus provisional stenting. Tryton Medical said that the device also showed "comparable major adverse cardiovascular events and myocardial infarction rates versus provisional stenting at three years." Meanwhile, the device's safety profile was validated in a confirmatory study "that met its primary endpoint, periprocedural myocardial infarction, which was within its non-inferiority margin," the company added.
Tryton Medical signed a distribution agreement with Cardinal Health enabling its interventional vascular business Cordis to be the exclusive US distributor of the Tryton Side Branch Stent. David Wilson, Cordis president, noted that "we are actively preparing to commercially launch this product."
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