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Medtronic's Onyx Frontier DES Gets FDA Approval

medtronic fda des 051322 lt

Medtronic plc (MDT), Friday announced that it has received U.S. Food and Drug Administration's approval for the Onyx Frontier drug-eluting stent (DES).

The company says the Onyx Frontier DES, which uses the same stent platform as Resolute Onyx DES, has improved deliverability and increased performance in even the most challenging of cases.

The company said that European CE Mark approval for the Onyx Frontier DES is pending.

"The new Onyx Frontier DES, with its enhanced deliverability, will continue to help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently," said Azeem Latib, M.D., section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York City. "Delivering safe and effective outcomes to our patients is our number one priority. It's important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes."

Onyx Frontier DES has several new changes to its design, including increased catheter flexibility, a dual-layer balloon technology and a lower crossing profile, which increases deliverability by 16% compared to previous generation Resolute Onyx DES.

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. CAD is the leading cause of death for both men and women in the United States.

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