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 

Related Content

First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
Tryton Medical, Side Branch Stent, first U.S. commercial case, New York-Presbyterian Hospital, Columbia University Medical Center
News | Stents Bifurcation| March 31, 2017
Tryton Medical Inc. recently announced that the first U.S. commercial case using the Tryton Side Branch Stent was...
Sponsored Content | Videos | Stents Bioresorbable| March 30, 2017
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses t
Gore Tigris Vascular Stent, Health Canada approval, PAD, peripheral artery disease
News | Stents Peripheral| March 16, 2017
W. L. Gore & Associates Inc. recently announced the Health Canada approval of the Gore Tigris Vascular Stent, a...
Sponsored Content | Videos | Stents Bifurcation| March 06, 2017
This video, provided by Tryton, demonstrates the implantation of the Tryton Side Branch Stent.
tryton side branch stent, dedicated coronary side branch stent

The Tryton Side Branch Stent is deployed in the side branch artery using a standard single wire balloon-expandable stent delivery system. A conventional drug eluting stent is then placed in the main vessel.

Technology | Stents Bifurcation| March 06, 2017
March 6, 2017 – The U.S.
Biosensors, BioFreedom drug-coated stent, LEADERS FREE II IDE trial, first patient, U.S. pivotal study
News | Stents Drug Eluting| March 03, 2017
Biosensors International Group Ltd. announced in February enrollment of the first patient in LEADERS FREE II, its new...
CeloNova Cobra Pzf stent
Technology | Stents| March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
Overlay Init