- Medtronic snagged FDA approval of an expanded indication for its Resolute drug-coated stent to treat patients with a condition known as chronic total occlusion, in which a coronary artery is completely blocked by the buildup of plaque.
- Data from the Perspective single-center, observational study of 183 patients who received a Resolute Integrity stent supported the expanded indication, demonstrating low rates of adverse events, the medtech giant said.
- The approval creates competition for Abbott's Xience stent in the subset of coronary artery disease patients with chronic total occlusion.
As the market for the wire-mesh tubes that prop open coronary arteries has matured in recent years, leading manufacturers Medtronic, Abbott and Boston Scientific have focused on advances in stent design and deliverability and improved polymer coatings that release medicines to prevent the vessels from re-clogging.
Patients with more complex coronary artery disease have benefited from the improvements in the newer-generation stents as rates of adverse events have been reduced. Medtronic highlighted low rates of adverse events after one year of treatment in the Perspective clinical study, with repeat revascularization of 1.1%, cardiac death at 2.2% and stent thrombosis of 0.6%.
Chronic total occlusion is a hard-to-treat condition found in about 20% to 30% of patients who undergo a routine diagnostic coronary angiography. Of those diagnosed, only about 5% to 7% are able to have a percutaneous coronary intervention (PCI), Medtronic said.
The difficulties involved in opening completely blocked arteries traditionally meant treatment options for patients with chronic total occlusion were limited to the more invasive coronary artery bypass grafting (CABG) or open heart surgery. But the advances in stent technology have made catheter-based PCI procedures an option for these patients.
In 2014, Abbott's popular Xience device became the first drug-eluting stent to receive FDA clearance for an additional indication to treat chronic total occlusion. It now faces a challenger in this niche with Medtronic's expanded indication for the Resolute stent.
Medtronic has dubbed Resolute its workhorse stent. FDA approved Resolute Integrity for coronary artery disease in February 2012 and Resolute Onyx, which boasts thinner stent struts and greater deliverability, in April 2017. Resolute Onyx comes in sizes from 2.0 mm to 5.0 mm. Both versions of the Resolute stent now have the green light to treat patients with de novo chronic total occlusion.