Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, announced that it has received CE Mark for the treatment of Left Main Coronary artery disease. With this approval, Tryton Medical becomes the first company to earn a CE Mark for this indication.
Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75 percent of left main lesions are bifurcations. There are approximately 200,000 cardiac surgeries performed in left main annually.
"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," said Dr. Robert-Jan van Geuns, M.D., Ph.D., of Erasmus MC (Rotterdam, the Netherlands). "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."
"Tryton Medical 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," said Shawn McCarthy, CEO of Tryton Medical. "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."
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.