The Resolute Onyx™ Drug-Eluting Stent (DES) from Medtronic plc (NYSE:MDT) has received an endorsement from the U.S. Food and Drug Administration (FDA). It will now be launched in the United States having obtained the clinical performance approval from its advanced deliverability.
The presence of the Resolute Integrity™ DES comes at a time when clinical studies claim that the latest technologies have not been able to establish a clinical advantage over durable polymer DES. Nonetheless, there is a lot to reap from the Resolute Onyx DES according to cardiologist and professor of medicine at Mount Sinai School of Medicine in New York City, Roxana Mehran.
Evolving stent technologies
The Resolute Onyx DES features the Core Wire Technology, which incorporates a radiopaque inner core within the cobalt alloy wire. Its main role is to enhance visibility for accurate stent placement. Thus, the Resolute Integrity DES is expected to reinforce the gold standard safety and effectiveness of DES technology.
The Resolute Onyx DES is primarily designed to provide treatment options to those struggling with extra-large vessels. This is the more reason the first 4.5 mm and 5.0 mm DES sizes will be made available in the US.
“The Resolute Onyx DES provides physicians with additional 4.5 mm and 5.0 mm sizes ………. while the stent`s enhanced visibility and excellent deliverability further differentiates it from other drug-eluting stents on the market,” Mehran emphasizes.
The expansion of DES technology
The Resolute Onyx DES is already making a significant impact in the US. Furthermore, it has also obtained the support of the RESOLUTE ONYX Core (2.25mm-4.0mm) Clinical Study. The VP and GM of the Coronary and Renal Denervation business, Jason Weidman explains that the market can expect more expansion of the technology through meaningful innovations.
He says that their intention is in advancing their DES portfolio to make it available to a wide range of patients. The collaborations that Medtronic has established with leading global clinicians, researchers and scientists could help make this possible. The company is well-known for its innovation in medical technology and its efforts in delivering products and services of economic value.
In the meantime, Medtronic’s stock closed at $83.74 witnessing an increase of $0.65 or 0.78%.