FDA Expands Drug-Eluding Stent to Treat De Novo CTO

The US Food and Drug Administration (FDA) has granted an expanded indication approval to Medtronic’s Drug-Eluding Stent (DES) platform for patients with coronary artery disease who have de novo chronic total occlusion (CTO).

Patients with CTO suffer a complex condition which results complete vessel blockage of a coronary artery, and is a far more difficult-to-treat condition with standard percutaneous coronary intervention (PCI), as complication risks are greater with invasive care. According to Medtronic, only about 5% to 7% of patients who are diagnosed with a CTO are capable of receiving PCI.

The DES platform, which includes the Ireland-based company’s Resolute Onyx and Resolute Integrity DES, is now indicated to treat the 20% to 30% of patients who undergo routine coronary angiography and are affected by CTO.

The approval addresses various challenges physicians face in treating CTO revascularization, David Kandzari, MD, director of Interventional Cardiology and chief scientific officer at Piedmont Heart Institute, said. The issues that arise are due to both limited procedural technique and tools.

“In part because of these challenges, CTO remains undertreated in interventional cardiology," Kandzari said in a statement. "The newest-generation, thin-strut Resolute Onyx DES, in particular, is well-suited to address the procedural challenges of deliverability and conformability, with now demonstrated excellent early and late safety and efficacy."

The FDA expanded approval was supported by data from the PERSPECTIVE Trial—of which Kandzari was the principal investigator. The single single-center, observational study assessed 183 CTO patients who had undergone stent procedure with Resolute Integrity, the older DES platform from Medtronic. Study results showed that patients treated with the platform reported low one-year post-treatment rates of repeat revascularization (1.1%), cardiac death (2.2%), and minimal stent thrombosis (0.6%).

The newest-generation of Medtronic’s DES platforms, Resolute Onyx, was approved by the FDA in 2017. It manufactures stent by forming a single strand of cobalt alloy wire in a sinusoidal wave, allowing for greater deliverability and conformability to the vessel, while maintaining its structural strength.

Kandzari noted this newest platform in particular is well-suited to address physicians’ challenges in stent procedure.

More clinical data and information regarding Resolute Onyx for the treatment of CTO will be made available at the Chronic Total Occlusion Summit, a Cardiovascular Research Foundation-funded meeting in New York, NY, this year.