With this approval, Tryton Medical becomes the first company to earn a CE Mark for this indication.

Dr Robert-Jan van Geuns of Erasmus MC (Rotterdam, the Netherlands) noted a predictable and safe outcome is essential for the treatment of this high-risk population.

"The Tryton Side Branch stent provides the necessary control in each step of the procedure. With the launch last summer of the Tryton SHORT stent, the expansive range of Tryton stents allows me to definitively treat the vast majority of my left main bifurcation lesions cases with a predictable procedure and durable result," Dr Geuns added.

Tryton Medical CEO Shawn McCarthy noted the company is dedicated to the treatment of all coronary bifurcations.

"Obtaining CE-mark approval for the left main indication significantly expands the market opportunity for our stent platform. As market leaders, we continue to invest and introduce meaningful product innovation, clinical evidence, and physician education, to advance the standard of care for bifurcated coronary artery disease," McCarthy added.

The Tryton side branch stent is commercially available in Europe and parts of the Middle East, is investigational in the US, and is not available in Japan.