Rumblings in the Drug-Eluting Stent market continued this week after Medtronic said it has obtained FDA approval for an additional indication for its Resolute DES platform and the Resolute Integrity.
The Dublin-based company’s new indication is for the treatment of patients with coronary disease who have de novo chronic total occlusion (CTO), a complex vessel condition involving complete blockage of a coronary artery. CTO is considered more difficult to treat with percutaneous coronary intervention (PCI) due to a greater risk of complications.
The expanded CTO indication was supported by data from the PERSPECTIVE Study, a single-center, observational study of 183 CTO patients who underwent a stent procedure with the older-generation Resolute IntegrityDES. Results showed that patients treated with the Resolute DES exhibited low rates of repeat revascularization (1.1%), cardiac death (2.2%) and minimal stent thrombosis (0.6%) at one year.
"This expanded indication will allow physicians the option to treat these more complex CTO cases with the Resolute Onyx DES, which has shown strong clinical performance across a variety of vessel sizes and anatomies," Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, said in a release.
Approved in the U.S. in 2017 following Resolute Integrity DES, the newest-generation Resolute Onyx is the first and only DES to feature Core Wire Technology, a unique Medtronic method of stent manufacturing that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent.
News of the expanded indication comes on the heels of Biotronik receiving approval for its DES system.