Following approval from the US Food and Drug Administration (FDA), Medtronic has launched the new 2mm Resolute Onyx Drug-Eluting Stent (DES) for the treatment of coronary artery disease (CAD).
The DES is for patients who have small vessels that could not be treated with larger stent technologies while performing percutaneous coronary intervention (PCI).
Resolute Onyx DES includes the Core Wire Technology, which is based on the firm’s stent manufacturing technique called Continuous Sinusoid Technology (CST).
CST is used to produce a stent by creating a single strand of cobalt alloy wire into a sinusoidal wave, while Core Wire Technology is designed for preparing thinner struts without comprising structural strength and visibility.
Medtronic Coronary and Renal Denervation business vice-president and general manager Dave Moeller said: “Furthering our core objective of developing technologies that address unmet patient needs, the introduction of the Resolute Onyx 2mm DES allows physicians to expand treatment options for patients with smaller vessels.
“The Resolute Onyx DES is an incredibly deliverable product that incorporates various design enhancements enabling physicians to optimise treatment for a wide range of patients.”
The 2mm stent expands the firm’s existing portfolio of Resolute Onyx 4.5mm and 5mm DES. This new stent is devised to expand from 2mm to a maximum-labelled diameter of 3.25mm after delivery.
For the approval, FDA reviewed the data obtained from the RESOLUTE ONYX 2mm clinical study, where the stent demonstrated low target lesion failure and target lesion revascularisation of 5% and 2%, respectively.
In addition, results did not indicate any stent thrombosis episodes or cardiac death at 12 months.
Medtronic also received new FDA indication for its continuous glucose monitoring sensor, Guardian Sensor 3, allowing its use on the upper arm of patients to manage automated insulin delivery through the firm’s MiniMed 670G system.