Medtronic has received the US Food and Drug Administration (FDA) approval for its Onyx Frontier drug-eluting stent (DES) to treat patients with coronary artery disease (CAD)
Onyx Frontier marks the latest development in the company’s Resolute DES family and leverages the same stent platform used in its Resolute Onyx DES.
The new device has undergone meaningful design changes, including enhanced catheter flexibility, advanced dual-layer balloon technology and a lower crossing profile, said Medtronic.
With the upgraded features, Onyx Frontier is said to have resulted in a 16% improvement in deliverability compared to the previous generation Resolute Onyx DES.
It is the only 2mm DES available in the US, similar to Resolute Onyx, and offers 4.5 to 5mm sizes that can be expanded to 6mm to support extra-large vessels.
Medtronic senior vice president and coronary and renal denervation business president Jason Weidman said: “The Onyx Frontier DES FDA approval is a very important milestone for Medtronic’s Coronary business and demonstrates our commitment to interventional cardiologists by providing best-in-class products.
“The Onyx Frontier launch also correlates directly to Medtronic’s commitment to engineering. The team built upon the design and clinical successes of the Resolute Onyx DES and has continued to evolve proven DES technology to further address the needs of physicians. We look forward to continuing the pursuit of innovation each day.”
In a separate development, Medtronic has completed the acquisition of California-based health care equipment company Intersect ENT for a total consideration of $1.1bn.
The transaction enables the company to expand its ear, nose, and throat (ENT) portfolio, with products related to sinus procedures to improve post-operative outcomes and treat nasal polyps.
As part of the deal, Medtronic has acquired Intersect ENT’s PROPEL and SINUVA sinus implant product lines and related technology and intellectual property.
PROPEL and SINUVA are unique bioabsorbable, steroid-eluting implants intended for the treatment of patients with sinus.
The transaction also included Intersect ENT employees and the company’s manufacturing facility in Menlo Park, California, US.
Intersect ENT president and CEO Thomas West said: “We believe the market leadership and global footprint of Medtronic, coupled with enterprise resources to fuel pipeline innovation and commercialization, will advance our reach to customers and patients more quickly and serve our shared vision.
“We are thrilled to combine these two companies as we now officially work together to bring more ENT options to patients.
“I am especially proud of our dedicated Intersect ENT employees, whose entrepreneurial spirit and passion for innovation have driven our ability to achieve this milestone.”
