|
Medtronic Launches Newest Drug-Eluting Stent:
The Onyx Frontier™
|
 |
Medtronic's Onyx Frontier Drug-Eluting Stent |
August 24, 2022 -- Medtronic's latest iteration of its Onyx Drug-Eluting Stent, the Onyx Frontier™,
was initially approved by the U.S. FDA back in May 2022. The device was recently granted the European CE Mark as well, so today the company launched the product.
The major improvement that the Frontier has made over the previous device is that it employs a more deliverable system which includes an innovative dual-layer balloon, a lower profile for crossing, and increased catheter flexibility. All of these refinements point to a 16% improvement in deliverability vs. the previous generation while maintaining its superior radial strength.
Additionally, all of the indications and clinical data from the previous Onyx stents apply to this newest version: approval for bifurcation lesions, left main PCI, and only one month of dual antiplatelet therapy (DAPT) for high bleeding risk patients.
Like the previous device, the Onyx Frontier is available in a wide range of sizes: from 2mm to 5mm in diameter, with the largest sizes of 4.5 and 5mm able to be expanded safely to 6.0mm for large vessels, such as the left main artery.
This morning's press release from Medtronic follows:
Medtronic Launches Latest Generation Drug-Eluting Coronary Stent System Following CE Mark Approval
Medtronic announced today that it has launched its newest drug-eluting coronary stent, the Onyx Frontier™ drug-eluting stent (DES), following recent CE Mark approval
August 24, 2022 -- Dublin -- Medtronic announced today that it has launched its newest drug-eluting coronary stent, the Onyx Frontier™ drug-eluting stent (DES), following recent CE Mark approval. The Onyx Frontier DES offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx™ drug-eluting stent. The DES leverages the same best-in-class stent platform as Resolute Onyx™ DES, with an enhanced delivery system1 designed to improve deliverability and increase acute performance in the most challenging cases.
Onyx Frontier DES’ meaningful design changes include an innovative dual-layer balloon, lower crossing profile, and increased catheter flexibility leading to a 16% improvement in deliverability vs. the previous generation Resolute Onyx DES without compromising on radial strength. In addition to the delivery system enhancements, Onyx Frontier offers a broad size matrix to treat patients ranging from 2.0mm to 5.0mm diameters and its 4.50-5.00 mm sizes1 can be expanded to 6.00 mm - specifically designed to support extra-large vessels including the left main. Onyx Frontier inherits the same clinical data and indications of Resolute Onyx, including approval for bifurcation lesions, left main PCI, and one month of dual antiplatelet therapy (DAPT) in high bleeding risk patients.
Jason Weidman |
"The Onyx Frontier DES launch demonstrates our commitment to interventional cardiologists by providing best-in-class products,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business unit, which is part of the Cardiovascular Portfolio at Medtronic. “Following our launch in the US, we're thrilled to provide hospitals across western Europe and the globe with the Onyx Frontier DES, which has been thoughtfully designed with physicians’ needs in mind. This launch furthers Medtronic’s goal of engineering the extraordinary, and we look forward to continuing to pursue innovation each day.”
The Onyx Frontier DES is used for the treatment of patients with coronary artery disease (CAD), which is caused by plaque buildup on the inside of the coronary arteries. These plaque deposits can narrow or clog the inside of the arteries, which decreases the supply of blood and oxygen to the heart. To help to restore blood flow, a physician may use a stent (a flexible metal scaffolding) that is delivered during a minimally invasive procedure to prop open the artery. A drug-eluting stent is the most common type of stent used to treat a blockage of the heart arteries.
The Onyx Frontier DES received FDA approval in the United States in May and recently received CE Mark in Europe.
Reported by Burt Cohen, August 24, 2022
|
