Medtronic ($MDT) won FDA approval for still more variations of its blockbuster Resolute Integrity stent. And in a global market that is already packed with plenty of competitors in the space, the Minnesota device giant is taking the approach this time that "size matters."
Specifically, the FDA approved new longer-sized 34mm and 38mm lengths of the company's Resolute Integrity drug-eluting stent, with 3mm, 3.5mm and 4mm diameters. The indication: to treat coronary artery disease in diabetic patients who have long coronary lesions.
But we'd be remiss in not reminding you that Boston Scientific ($BSX) already did the same thing in June, also gaining the FDA's OK for larger-sized 32mm and 38mm lengths of its Promus Element drug eluting stent to treat coronary artery disease. And Medtronic's latest FDA nod for Resolute Integrity follows its CE mark in May 2012 for seven new indications for the stent, allowing it to treat everything including acute coronary syndromes to total occlusions, diabetes and more.
Medtronic's move makes sense. Coronary stent competitors are plentiful and vying for attention, both overseas and in the U.S. And so any way to stand out can help make the difference. With this in mind, Medtronic, Boston Scientific and all the others are pursuing approvals for as many indications, sizes and shapes for a given stent as possible. What's more, as health care providers look increasingly for value as well as quality outcomes, stent manufacturers are betting that a product with the most market options will gain their attention.
For these latest Medtronic Resolute Integrity stent approvals, the FDA made its decision, in part, based on results from the company's global RESOLUTE clinical program. Their analysis involved data from patients from both the RESOLUTE US and RESOLUTE Asia studies who faced long coronary lesions.
- read the release