Technology | Stents Drug Eluting | May 01, 2017

FDA Approves Medtronic Resolute Onyx Drug-eluting Stent

Engineered for improved deliverability, features thin struts, enhanced visibility and broadest size range

Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval, core technology

The device is the first DES to feature core wire technology, an evolution of Medtronic’s continuous sinusoid technology. This involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. The vendor said this enables greater deliverability and conformability to the vessel wall.

May 1, 2017 — The U.S. Food and Drug Administration (FDA) approved Medtronic’s Resolute Onyx Drug-eluting Stent (DES). The device is the first DES to feature core wire technology, an evolution of Medtronic’s continuous sinusoid technology (CST).

CST is a unique method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. The vendor said this enables greater deliverability and conformability to the vessel wall. With core wire technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. The technology also enables thinner struts while maintaining structural strength.

Watch a VIDEO animation of how the stent is deployed in the cath lab.

“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES,” said Roxana Mehran, M.D., cardiologist and professor of medicine at Mount Sinai School of Medicine in New York City. “The Resolute Onyx DES provides physicians with additional 4.5 and 5 mm sizes to treat patients with large coronary anatomies, while the stent’s enhanced visibility and excellent deliverability further differentiates it from other drug-eluting stents on the market.”
 
The new stent was designed with the transradial approach in mind, including 5 French catheter compatibility with stent sizes up to 5 mm. With the first 4.5 and 5 mm DES sizes available in the U.S., the Resolute Onyx DES helps expand treatment options for patients with extra-large vessels, Medtronic said.
 
The Resolute Onyx is supported by data from the RESOLUTE ONYX Core (2.25 - 4 mm) Clinical Study, as well as the long-term safety and efficacy with low stent-thrombosis rates in the Global RESOLUTE Clinical Program. It uses the BioLinx polymer — specifically designed for DES — that features a unique hydrophilic and hydrophobic blend, allowing rapid endothelial healing with minimal inflammation and low risk of stent thrombosis.

The Resolute Onyx DES is available for use in the United States, as well as in Europe and other countries that recognize the CE (Conformité Européene) mark.

 

Related Onyx and CST Technology Content

Medtronic Announces Clinical Study of Drug-Filled Stent

Watch the VIDEO “Drug-Filled Stents as an Alternative to Polymer Drug Carriers at TCT 2015.”

First Clinical Data of Medtronic Drug-Filled Stent Show Positive Outcomes

Medtronic Announces New Sizes, Indications for Resolute Onyx Drug-eluting Stent

 

For more information: www.medtronic.com 

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