Medtronic has launched their Resolute Onyx drug-eluting stent (DES) in India. It features a new advancement called CoreWire Technology which enables increased radiopacity (i.e., visibility during the procedure). Dr Peter Andreka, Medtronic’s international key opinion leader (KOL), shares more details about the product and explains its advantages in detail, in an interaction with Lakshmipriya Nair
What differentiates Onyx from its counterparts?
Over the past 20 years, stents have evolved from a plain vanilla bare metal stent to new generation drug eluting stent (DES). Resolute Onyx DES is a revolution in stent technology. It is the most deliverable DES, featuring Core Wire Technology. CoreWire Technology is the next new DES advancement after Continuous Sinusoid Technology (CST). Core Wire Technology combined with CST enables thinner struts without compromise in radiopacity or overall structural strength. Wrapped in a cobalt alloy shell, the denser, more radiopaque inner core material allows for improved visibility during procedure, referred to as radiopacity. The cobalt alloy shell maintains the mechanical performance and structural strength of the stent material thus improving deliverability and acute performance.
Typically, a stent is a tiny, expandable, mesh-like tube made of metal and strut (refers to a strand of metal in the mesh). A stent, then mounted onto a tiny balloon, is opened inside of an artery to push back plaque and to restore blood flow. Traditionally, with thicker struts, there was always a high risk of injuring the wall of the artery during delivery. Also, delivering and navigating the stent through very tortuous arteries would be a problem. Resolute Onyx has thinner struts to help improve deliverability without compromising radial and longitudinal strength of the stent and has proven long-term safety and efficacy. Resolute Onyx DES builds on the Resolute Integrity platform’s acute procedural success for even greater flexibility and conformability.
How is the technology unique and what are its advantages?
The designs of current second generation DES are tested and proven in a broad spectrum of complex anatomical and patient subsets; they are the foundation for the excellent clinical outcomes seen with DES today. However, despite the solid clinical performance of current second generation DES, there are still potential areas of focus that may further improve outcomes like radiopacity, conformability, deliverability, procedural success. In order to achieve these improvements, next generation devices must consider design enhancements that look to things like platform updates, optimised materials and thinner struts, all without compromising structural strength. Resolute Onyx combines all these aspects in one and is an advanced DES for effortless navigation to unreachable lesions and precise placement in critical procedures. Also, there are medicines administered to post surgery patients, termed as DAPT –dual anti platelet therapy. The DAPT is a combination of two drugs (aspirin and clopidogrel) that are given orally to such patients to prevent stent thrombosis which is a condition when a previously placed stent in a coronary artery suddenly gets blocked because of a blood clot. Generally a DAPT is recommended for a period of 12 months after a stent is implanted in the body. But with the medical technology advancements and availability of DES like Resolute Onyx, the duration of the DAPT medications administered post-surgery can be reduced without compromising on clinical performance. It brings down the duration of DAPT from 12 months straight to one month, thereby liberating the patient from the daily intake of the DAPT medicines earlier without putting the patient at a risk of stent thrombosis.
What makes India a good market for Onyx?
With ~ 61.5 million coronary heart disease (CHD) patients in 2015, India becomes one of the largest contributors of CHD patients in the world. By 2020, India is expected to have the largest disease burden in the world and shall account for one-third of the deaths. Approximately 9-10 per cent of the CHD patients suffer from an acute coronary event, accounting for four to five million cases of Acute Coronary Syndrome (ACS) every year. Of this only ~ 1.6 million patients are treated with cardiac stents over the past 10 years. Cardiac stent therapy penetration in India is at 2.6 per cent of the diseased population. Cardiac stents are indicated as the first line of treatment for CAD patients with acute myocardial Infarction. Application of Core Wire Technology with Onyx makes it an exciting innovation that will have measurable impact on clinical practice today and tomorrow. All the above listed features incorporated in the Resolute Onyx coronary stent system allows the stent to be at least 20 per cent more deliverable than the current generation DES. When coronary stents fail to cross a tortuous anatomy they become ideal candidates for surgical revascularisation to provide relief from angina due to blocked artery. These could be the situations where Resolute Onyx, due to its superior deliverability, is able to reduce the need of surgical revascularisation in patients with angina due to occluded artery.
What has been the global response for this product?
The global response is very good. In Hungary, quite a high number of Resolute Onyx stent has been implanted, all with very good result. The excellent deliverability and visibility of this stent helped us a lot to avoid cardiac surgery with successful stenting.