Medtronic bags FDA nod for stent tipped to halt falling sales

Medtronic has won FDA approval for its Resolute Onyx drug-eluting stent (DES). The approval sets Medtronic up to start selling a stent it claims offers greater flexibility without sacrificing structural strength in the U.S.

Resolute Onyx DES is made out of a single strand of cobalt alloy wire with a platinum-iridium core that is formed into a wave, wrapped up to form a tube around a radiopaque inner core and fused. Medtronic took this approach to reduce the thickness of the device's struts, improve its visibility and make the it flexible without reducing its strength. The stent is available in sizes of up to 5 mm, making it the largest DES available in the U.S.

Roxana Mehran, M.D., a cardiologist at Mount Sinai School of Medicine, sees that mix of features as attractive.

“The Resolute Onyx DES provides physicians with additional 4.5 mm and 5.0 mm sizes to treat patients with large coronary anatomies, while the stent’s enhanced visibility and exceptional deliverability further differentiates it from other drug-eluting stents on the market,” Mehran said in a statement.

Medtronic secured approval for the stent on the strength of data from the RESOLUTE Global Clinical Trial Program. Five-year data from 7,618 patients presented in January linked Resolute zotarolimus-eluting stents to cumulative incidence of cardiac events and stent thrombosis of 13.4% and 1.2%, respectively. Medtronic also used data from the 75-person Resolute Onyx Core (2.25 mm - 4.0 mm) Clinical Study to secure approval.

Clearance to sell the device in the U.S. comes more than two years after Medtronic picked up a CE mark and commercialized the stent in the European Union.

A lot is resting on the commercial performance of the stent in the U.S. Talking to investors during a third quarter results conference call in February, Medtronic CEO Omar Ishrak said the company is looking to the device to “turn the mid-twenties U.S. DES sales declines into meaningful growth” in the 2018 fiscal year.

Medtronic revealed its success in bringing the product to market in the U.S. days after it learnt it had failed in its attempt to pull the stent from the market in India. The device manufacturer asked to withdraw its Resolute Onyx DES from the Indian market after the country introduced a price cap on cardiac stents. Medtronic claims the ceiling makes the sale of Resolute Onyx DES commercially unviable but regulators rejected its withdrawal request, pointing to an order that forces the firm to maintain supplies for six months to explain their decision.