Medtronic ($MDT) won two more peripheral artery disease treatment options in the U.S. for its Complete self-expanding vascular stent. The FDA signoff on expanded indications is an important step to reach more patients as rivals nip at its heels.
The FDA approved Complete SE (its formal name) to restore blood flow to the superficial femoral artery and proximal popliteal artery. Both transport blood through the upper legs. Previously, the Minnesota medical device giant has only had FDA approval to treat the iliac arteries in the pelvis. As of earlier this summer, Medtronic also has a CE mark in hand for all three indications.
In the U.S., Medtronic relied on the data from its Complete SE SFA study to win the FDA's backing for more treatment options. The trial was fairly large, involving 196 patients at 28 sites in the U.S. and Europe. Medtronic celebrated study results that included an 8.4% repeat procedure rate at one year, and in-hospital major adverse events that hit the 11% mark in the same time period.
This was an important win for Medtronic for a number of reasons. Rates of diabetes, obesity and elevated blood pressure are profoundly high in the U.S., and all contribute to peripheral artery disease, which leads to plaque buildup in blood vessels, less blood flow to the arms and legs, amputations and death. And an aging population will only add to a patient base that is already sizable (an estimated 27 million PAD patients around the world).
That means the more peripheral artery disease options Medtronic can address, the better off it will be in the marketplace. Expanded indications for Complete SE will help as it pursues approval for another product also targeted to PAD: IN.PACT Admiral, a drug-eluting balloon. And then there's the competition. Rivals including Boston Scientific ($BSX) are close behind. In August, Boston Scientific began a multicenter trial of Innova, a self-expanding stent to treat PAD that already has a CE mark.
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