FDA approves single-wire DES system to treat non-left main bifurcation lesions
Medtronic announced it received FDA approval for its provisional bifurcation stenting technique utilizing a single drug-eluting stent for non-left main bifurcation lesions.
The systems (Onyx Frontier and Resolute Onyx) are the only DES approved featuring a single-wire design meant to improve vessel conformability, improve side branch access and provide the option to open the stent cell while maintaining stent scaffolding, according to a press release issued by the company.
“The bifurcation expanded indication is yet another exciting milestone for our coronary business this year,” Jason Weidman, senior vice president and president of the coronary and renal denervation business at Medtronic, said in the release. “As the first and only medical device company to offer this indication to U.S. interventional cardiologists, Medtronic remains committed to investing in DES technology, clinical evidence and physician education.”