Medtronic landed a significant win with the announcement of an FDA win for its Resolute Integrity drug-eluting stent, the first device on the U.S. market cleared for patients with coronary artery disease as well as diabetes.
Diabetic patients make up about ⅓ of all those with CAD, and they represent a difficult-to-treat population.
"They tend to have smaller and often tortuous arteries, longer lesions, diffuse disease and a higher rate of treatment failures including relatively high rates of repeat procedures and stent thrombosis," Medtronic told MassDevice in an email. "As a result, many of these patients have undergone open heart surgery."
The need for treatment options for the patient population is significant. CAD is the leading killer in the U.S. and will be the cause of death in more than half of the total diabetes population, according to Medtronic.
While percutaneous coronary interventions are often used for diabetic patients with CAD, no drug-eluting stent had previously been approved specifically for those patients.
Because of the complications arising from the co-morbidity, many patients are treated with open heart surgery, a more invasive option that requires extended hospital care and recovery time compared to stenting procedures, according to a press release.
The zotarolimus-eluting Resolute Integrity stent system demonstrated "remarkably safe and effective outcomes" for diabetic patients with heart disease" in a series of global studies that Medtronic touted at various conferences over the last year.
The device’s new "continuous sinusoid technology," – it’s made with a continuous strand of wire – makes each stent comparable to a flexible spring and gives it more deliverability than alternative stents, according to a press release.
The Minneapolis, Minn.-based med-tech titan expects the Resolute Integrity DES to be a "key financial driver for the company in their next fiscal year," according to the company.
"Based on how well the Resolute Integrity has performed outside of the U.S., where it has been available since fall of 2010, we expect it to do quite well in the U.S. where it has had few competitors," Medtronic spokesman Joe McGrath told MassDevice today.
Abbott Labs (NYSE:ABT), with its Xience DES, and Boston Scientific (NYSE:BSX), with the Promus stent, are the 2 remaining large-cap players with drug-eluting stents on the U.S. market. Johnson & Johnson’s (NYSE:JNJ) Cordis Corp., once a formidable player, dropped out of the the stent game altogether at the end of last year.
Commercial launch of the Resolute Integrity system began yesterday.
Despite that win, MDT shares were down this morning on a narrowed earnings outlook for 2012 in the company’s fiscal Q3 earnings report. The company maintained its guidance for sales growth of between 1% and 3%, but "tightened" its earnings outlook for fiscal 2012, to between $3.44 and $3.47.
Chairman & CEO Omar Ishrak said the FDA win for the Resolute Integrity system "should contribute to improved revenue performance," according to a press release. The company’s coronary unit reported sales of $382 million during the quarter, up 3.2% compared with Q3 2011.
"The entire cardiac and vascular group sales force will be involved in selling the Resolute Integrity stent, and that’s about 2,800 employees," McGrath said. "Medtronic continues to sell the Endeavor drug-eluting stent, which has about 10% market share, and with the addition of Resolute Integrity we expect that share to increase significantly," he said