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First dedicated coronary bifurcation stent receives FDA approval
Tryton Medical Inc. announced the FDA premarket approval of a stent designed for the treatment of coronary bifurcation lesions involving large side branches.
The stent (Tryton Side Branch Stent) is the first specifically designed for treatment of coronary bifurcation lesions to receive FDA approval, according to a press release issued by the company.
According to the release, PCI of bifurcation lesions has typically been performed with provisional stenting of the main branch, but in many cases, the side branch is left unstented, which may make the side branch vulnerable to complications, such as occlusion that requires bailout stenting.
“It is estimated that nearly one-third of all patients treated with angioplasty each year have a bifurcation lesion and the standard provisional treatment approach leads to side branch occlusion and bailout stenting far too often,” Shawn McCarthy, president and CEO of Tryton Medical, said in a press release. “With this first-of-its-kind approval in the U.S., interventional 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.”
A post hoc analysis of a randomized investigational device exemption clinical trial showed that treatment Tryton stent reduced the need for additional bailout stenting (0.7% vs 5.6%, P = .02) and was associated with significantly lower side branch percent diameter stenosis at 9 months (30.4% vs 40.6%, P = .0004) compared with provisional stenting, according to the release.
The Tryton stent was also associated with MACE and MI rates comparable to provisional stenting at 3 years, the company stated in the release.
A confirmatory study conducted to compare patients treated with the Tryton stent against a performance goal based on the control arm from the randomized IDE clinical trial, met its pre-specified primary endpoint of periprocedural MI, which was within the margin of noninferiority (Upper bound of 95% CI for primary endpoint, 10.5%; historical performance goal, 17.9%; P = .01), according to the release.
“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,” Aaron Kaplan, MD, professor of medicine at Dartmouth Hitchcock Medical Center and chief medical officer at Tryton Medical, said in the release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting.”
According to Kaplan, the approval could have impact on treatment protocols and guidelines for the treatment of bifurcation lesions.
Tryton also stated in the release that it signed an agreement with Cordis, the interventional vascular business of Cardinal Health, to be the exclusive distributor of the stent in the U.S.
Disclosure: Kaplan and McCarthy are employees of Tryton Medical.