Tryton Medical has becomes the first company to earn a CE Mark for the treatment of Left Main Coronary artery disease.
Background
Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation.
Left main disease 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.
Stent maker Tryton Medical positions itself as the leader in the field when it comes to delivering stents designed to address bifurcations, so it’s perhaps unsurprising that the company is the first to gain CE mark approval for use of its stent in Left Main Coronary artery disease.
Physician comments
“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.”
Company comments
“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.”
Regulatory status
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.
Source: Tryton Medical, Inc., Business Wire
published: February 13, 2014 in: Approval/Clearance, Cardio