Tryton Medical said yesterday it launched a post-approval study of its Tryton Side Branch Stent system designed for treating coronary artery disease.
The side-branch stent is designed to be compatible with any conventional drug-eluting stent in the main vessel, and comes in sizes ranging from 2.5mm to 3.5mm, the Durham, N.C.-based company said.
“Greater than 20% of all percutaneous coronary interventions involve a bifurcation for which Tryton is the only FDA approved device. The enrollment of the first patient in the study is yet another milestone for Tryton, confirming the company’s commitment to education and understanding of the treatment of bifurcation disease in complex PCI,” prez & CEO Carl St. Bernard said in a prepared statement.
The first case in the study was recently performed by Dr. Robert Jobe and principal investigator Dr. Joel Schneider at Raleigh, N.C.’s NC Heart and Vascular, Tryton Medical said.
“The Tryton stent has become the critical component for predictably treating my patients with coronary bifurcation lesions. This post approval study is anticipated to confirm the excellent procedural and long term clinical outcomes we obtained in the Tryton pivotal study,” Dr. Schneider said in a press release.
Last March, Tryton said its Side Branch Stent had been used in its 1st commercial procedure, performed by Dr. Martin Leon and Dr. Ajay Kirtane at the New York-Presbyterian Hospital.