Medtronic plc’s winning streak continued this week with the announcement that the U.S. FDA had given its nod for new one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx drug-eluting stent (DES).
"The journey leading to an HBR indication has included years of rigorous clinical evaluation with more than 22,000 complex patients studied," noted Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. The approval is based on results from the Onyx ONE Clear Study that evaluated about 1,500 complex HBR patients on one-month DAPT treated with Resolute Onyx.
Indeed, at one year, the study met its primary endpoint of cardiac death or myocardial infarction and showed Resolute Onyx to be safe and effective in HBR patients on one-month DAPT. Results from the study were shared virtually in March at the American College of Cardiology together with the World Congress of Cardiology Scientific Sessions.
"It is remarkable how the combination of technology innovation, in conjunction with the generation of clinical evidence, has informed our understanding that shorter durations of DAPT may in fact be safe in appropriately selected patients treated with Resolute Onyx DES," explained Ajay Kirtane, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and principal investigator for the Onyx One Clear study.
According to the company, the Resolute Onyx is the first DES in the U.S. that has been proven safe and effective utilizing a one-month regimen of DAPT – the combination of aspirin and an anti-clotting medication – following a percutaneous coronary intervention in patients at high bleeding risk.
Individuals who are at risk for high bleeding include older patients, as well as those with a history of bleeding or who are on oral blood-thinning drugs. The company pointed to clinical studies that have demonstrated that Resolute Onyx DES and its biocompatible polymer and stent design promote fast vessel healing and is well-suited for patients who may benefit from a DAPT duration as short as one month.
For its part, Boston Scientific Corp. has received the U.S. FDA’s nod for an HBR indication for the Synergy drug-eluting stent system. The company said in August the approval makes Synergy the first such platform in the U.S. with an indication for HBR.
Last September, the Marlborough, Mass.-based company revealed primary endpoint results from the EVOLVE Short DAPT clinical trial, which looked at the safety of a shortened duration DAPT in patients at high risk for bleeding.
Results from the study showed that a three-month regimen of DAPT is noninferior to a 12-month or longer regimen in individuals facing an increased risk of bleeding after being treated with the Synergy bioabsorbable polymer stent.
This marks just the victory for the device in 2020. Earlier this year, Medtronic, of Dublin, reported that it had secured the CE mark for a one-month DAPT indication for HBR patients implanted with the device. Medtronic heralded the approval as the first of its kind globally.
In addition, Medtronic has been busy just over this last week, with another big piece of news being word of the planned acquisition of Avenu Medical Inc. That company focuses on the endovascular creation of arteriovenous fistulae for patients with end-stage renal disease undergoing dialysis. The two did not disclose the terms of the transaction.
Further, its wholly owned subsidiary Medtronic Global Holdings SCA has closed a registered public offering, with net proceeds expected at about €6.2 billion (US$8 billion), after deducting underwriting discounts and commissions and estimated expenses related to the offering payable by Medtronic Luxco.
Many analysts remain bullish about the prospects for Medtronic, including Margaret Kaczor, of William Blair. While COVID-19 might still have a near-term impact, the company does have a strong balance sheet to invest in employees and R&D, she explained in a Sept. 25 note. With that said, while her group remains “encouraged by the number of catalysts that could accelerate top-line growth, … we will wait for execution on pipeline products to demonstrate Medtronic’s ability to accelerate growth sustainably.”