FDA approves Medtronic’s Onyx Frontier drug-eluting stent for treating CAD

USA – The US Food and Drug Administration (FDA) has approved the Onyx Frontier drug-eluting stent (DES) to treat patients with coronary artery disease (CAD), the device manufacturer, Medtronic has announced.

The Onyx Frontier is based on the same stent platform and clinical indications as the previous generation Resolute Onyx zotarolimus-eluting stent, including the most recent approval for patients at high risk of bleeding who may benefit from only one month of dual antiplatelet therapy.

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.

In addition to the enhanced delivery system enhancement, the Onyx Frontier also offers a broad size matrix to treat more patients and joins the Resolute Onyx as the only 2.0 mm DES available in the United States.

Onyx Frontier is available in 4.5-5mm sizes that can be expanded to 6.00 mm, and shares the same clinical indications as Resolute Onyx, including the most recent approval for patients that are at high risk of bleeding who may benefit from a dual antiplatelet therapy (DAPT) duration as short as one month.

In Europe, the Onyx Frontier DES is awaiting CE Mark.

The Onyx Frontier DES is used to treat patients who have coronary artery disease (CAD), which is caused by plaque buildup inside the coronary arteries.

These plaque deposits can narrow or clog the inside of the arteries, reducing blood and oxygen supply to the heart. In the United States, CAD is the leading cause of death for both men and women.

In another milestone, Medtronic has closed the deal of its US$1.1 billion acquisition of medtech device company Intersect ENT, just a few days after the FTC said the buyout could only proceed if Intersect ENT subsidiary Fiagon was sold off within 10 days of the deal’s close.

The newly divested company manufactures the Cube ear, nose, and throat navigation system as well as the VenSure balloon sinus dilation system.

The FTC concluded in an antitrust review of the proposed acquisition that adding those technologies to Medtronic’s existing market-leading ENT portfolio would significantly reduce competition and innovation in an already very narrow space, driving up healthcare costs for patients and providers.

Intersect’s proposal to sell Fiagon to Hemostasis, which had only one product in the ENT market before acquiring Fiagon’s assets, was approved by the agency. The terms of the transaction were not disclosed.

Intersect’s remaining ENT devices are now part of the Medtronic family. They include a pair of bioabsorbable, steroid-eluting implants that have been approved by the FDA for patients with chronic rhinosinusitis.

The Propel implant, which has also received CE mark clearance in Europe, is used to keep sinuses clear following an endoscopic sinus procedure, whereas the Sinuva device is used to treat nasal polyps that develop after ethmoid sinus surgery.

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