US-based Tryton Medical has received CE Mark for its side-branch stent for the treatment of left main coronary artery disease.
According to the company, approval makes it the only coronary bifurcation stent cleared in Europe for the left main indication.
Left main disease is an accumulation of plaque that narrows the base of the coronary tree. There are approximately 200,000 cardiac surgeries performed in left main annually.
In May 2013, Tryton side branch short stent was approved in the European Union increasing the number of treatment options in large vessel bifurcations associated with a short main branch landing zone.
Erasmus MC (Rotterdam, the Netherlands) Dr Robert-Jan van Geuns said 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," Dr Geuns said.
"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."
The Tryton side branch stent is currently available for sale in Europe and parts of the Middle East, is investigational in the US, and is not available in Japan.
The device was developed based on the company's proprietary, first-in-class Tri-ZONE technology.
It offers a dedicated strategy for treating bifurcation lesions and is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.
Tryton Medical CEO Shawn McCarthy said: "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."