The FDA approved Tryton Medical’s stent for the treatment of coronary bifurcation lesions, or cases of coronary artery disease where plaque accumulates where an artery branches from another.
Coronary artery disease is the most common form of heart disease, according to the Centers for Disease Control and Prevention. CAD, characterized by the buildup of plaque in the coronary arteries, can lead to angina or a heart attack, and leads to more than 370,000 deaths in the U.S. each year, the CDC says.
While 20 to 30% of patients undergoing percutaneous coronary intervention have a bifurcation lesion, Tryton said in a statement, Tryton’s Side Branch Stent is the first device to earn FDA approval for the treatment of such lesions. The standard of care involves stenting the main artery, but not the side branch, which can result in complications, Tryton said.
During PCI, the interventionist predilates the side branch and then positions and deploys the Tryton stent, the company explained in a video. A drug-eluting stent is then placed in the main artery.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, M.D., a professor of medicine at Dartmouth-Hitchcock Medical Center and chief medical officer of Tryton Medical, in the statement. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
Tryton filed its PMA submission in November 2015. And last fall, it struck a distribution agreement with Cardinal Health, under which the latter’s Cordis subsidiary will exclusively market the stent in the U.S.
“This strategic agreement is a significant step for Cordis to quickly get innovative technologies into the hands of our customers in the U.S.,” said Cordis President David Wilson. “We are actively preparing to commercially launch this product with Tryton to ensure physicians will soon have a new treatment option in their cath labs to help deliver the best patient care available.”