FDA Approves Stent for Troublesome Cardiac Artery Lesions

Posted in Regulatory and Compliance by Nancy Crotti on March 9, 2017

The Tryton side-branch stent is compatible with stents manufactured to treat lesions in the main coronary artery, according to its North Carolina manufacturer.

Nancy Crotti

Tryton Medical's side-branch stent is designed to treat, protect, and secure bifurcation lesions and integrates into any conventional drug-eluting main vessel stent. 

 

FDA has approved a stent to treat plaque buildup in side branches of coronary arteries, nine years after the device received the CE mark in Europe.

Known as bifurcation lesions, these plaque buildups can be challenging for interventional cardiologists to treat because current stents do not come in a “Y” configuration. The Tryton side-branch stent is deployed in the side branch artery using a standard, single-wire, balloon-expandable stent delivery system, according to its manufacturer, Durham, NC-based Tryton Medical Inc. The main artery stent is then deployed and the two are joined into the “Y” configuration using the “kissing balloon” technique.

About 20% to 30% of all patients undergoing percutaneous coronary interventions to open blocked arteries have a bifurcation lesion. Provisional stenting of the main branch is the current standard of care, but the side branch is often not stented, leaving it vulnerable to complications like occlusion, which may require bailout stenting.

A randomized investigational device exemption (IDE) clinical trial showed that treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (appropriate for a ≥2.5mm stent) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = 0.02) and led to statistically significant lower side branch percent diameter stenosis at nine-month follow up (30.4% vs. 40.6%, P = 0.004) when compared to provisional stenting. A post hoc analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates versus provisional stenting at three years.

The safety profile of the Tryton side branch stent was validated in a confirmatory study. The company was founded in 2003 by Aaron Kaplan, a professor of medicine at the Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, to develop stents for the definitive treatment of bifurcation lesions.

The cobalt-chromium Tryton stent is available in multiple device diameters (2.5mm to 3.5mm in the side branch) and is compatible with any conventional drug-eluting stent in the main vessel, Tryton CEO Shawn McCarthy told Qmed.

“You can match it perfectly,” McCarthy said. “It’s very easy to use, and very predictable.”

The Tryton stent has been used to treat more than 12,000 patients in Europe, the Middle East, and Africa, the company noted. Tryton has signed a U.S. distribution agreement with Cardinal Health. It will become available later this month, McCarthy said.

Nancy Crotti is a contributor to Qmed.

 

[Image credit: Tryton Medical Inc.]