Tryton Medical won a CE mark for a short version of its Side Branch Stent to treat bifurcated lesions, a crucial step toward reaching more patients and pursuing the company's U.S. approval pathway.
CEO Shawn McCarthy told FierceMedicalDevices that the company will sell its shorter-version stent in many of the same places where the standard one has had CE mark status for the last three years. That means a limited launch in 18 countries served by the company's distribution network, including Germany, the U.K., the Netherlands, Spain, Italy, Russia and Israel. The short stent is 15 mm, 3 mm shorter in the main branch zone than its standard product.
The variation will help treat more patients who have more problems and are built in a way where a longer stent won't work well. And Tryton says it sees a market potential for its technology of up to 700,000 procedures annually around the world.
Tryton raised $24 million in new financing just in January, and that money will help support the new new product launch and continue its pursuit of FDA approval for the standard Side Branch Stent, which treats left main disease. It helps revascularize lesions during percutaneous coronary inventions and is targeted at the one-third of patients who receive the procedure and must deal with restenosis when the artery bifurcates, or splits (a drug-eluting stent goes in the primary artery).
A pivotal study involving 704 patients finished enrollment in November, and the company now has nine-months in follow up data. Plans call for suing that data to help support a PMA approval by year-end. McCarthy told us that the company is actively talking with regulators about an approval strategy for its shorter stent, and seeking regulatory approval in various Asian markets.
While side branch stents to treat bifurcated lesions are more common in Europe, the U.S. doesn't yet have the technology available. McCarthy said he sees his company as having a major lead here, compared to its rivals.
"We will be the first in the U.S.," McCarthy said. "We have a two to three year lead before anyone else will be able to follow us. And no one has an approved IDE that we are aware of."
Launched 8 years ago, North Carolina-based Tryton employs just under 20 full-time and contract employees, and has raised close to $60 million in venture funding to date.
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