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Medtronic gets FDA nod for smallest sized drug-eluting stent to treat CAD

MDBR Staff Writer Published 27 February 2018

Medtronic has secured approval from the US Food and Drug Administration (FDA) for Resolute Onyx 2.0mm drug-eluting stent (DES), which is claimed to be the smallest sized DES on the market.

Launched in the US market, the new stent is designed to support interventional cardiologists treat patients with coronary artery disease (CAD) who have small vessels often untreatable with larger stent technologies during percutaneous coronary intervention (PCI).

According to the company, around 65% of smaller vessels are located in critical locations of the heart, making them significant lesions to treat.

Medtronic also provides Resolute Onyx DES in 4.5mm and 5.0mm sizes, in addition to the new stent.

The stent is also engineered with the lowest crossing profile of any DES (less than 1 mm) allowing better deliverability.

The Resolute Onyx 2.0 mm DES can be extended from 2.0 mm to the maximum labeled expansion diameter of 3.25 mm.

Resolute Onyx DES platform features Core Wire technology, which is developed based on continuous sinusoid technology (CST).

CST is a Medtronic method of stent manufacturing that involves making a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent.

The company is marketing the Resolute Onyx DES in all sizes in the US, as well as in Europe and other countries that accept CE mark.

Resolute Onyx 2.0mm clinical study national principal investigator Matthew Price said: "Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures.

“The Resolute Onyx 2.0 mm DES is an extremely deliverable stent that, when needed, can be post-dilated to 3.25 mm to treat lesions in difficult-to-reach areas of the heart."

Medtronic cardiac and vascular group coronary and renal denervation business general manager Dave Moeller said: "Furthering our core objective of developing technologies that address unmet patient needs, the introduction of the Resolute Onyx 2.0 mm DES allows physicians to expand treatment options for patients with smaller vessels.”

Image: Medtronic operational headquarters. Photo: courtesy of Medtronic.