Medtronic Inc. said Monday it’s received U.S. approval to sell a drug-coated balloon device used to reopen blood vessels in legs narrowed by peripheral artery disease. It’s a minimally invasive treatment alternative to angioplasty and stents that is believed to have considerable sales growth potential.
Fridley-based Medtronic is the second company to receive such U.S. approval, and its pending acquisition of Covidien is seen as adding considerable sales muscle for the product later this year.
A senior analyst with Wells Fargo predicted that last year’s $91 million global market for drug-coated balloon devices will grow sixfold by 2020 — and Medtronic is on pace to capture most of it, starting with $160 million in sales this year.
More than 700,000 people around the world were treated surgically for symptoms of peripheral artery disease in 2013, and that figure is expected to grow even as rates of contributing conditions like diabetes level off in countries like the U.S. Within five years, experts say as many people around the world will be treated with drug-coated balloons as with traditional angioplasty.
The Food and Drug Administration on Monday approved Medtronic’s In.Pact Admiral drug-coated balloon for domestic sales, just three months after the agency greenlighted the U.S.’ first therapeutic ballon, Lutonix, made by C.R. Bard of Murray Hill, N.J. Boston Scientific is developing a similar device, as is Denver’s Spectranetics, which agreed to acquire Covidien’s Stellarex product while still in development, for $30 million.
Regulators required the sale of Stellarex due to Covidien’s pending acquisition by Medtronic, which shareholders of both companies are expected to approve in voting Tuesday.
The Covidien acquisition, expected to close soon, will put Medtronic devices like the In.Pact Admiral in the hands of a Covidien sales force well accustomed to hospitals and outpatient departments. The acquisition, expected to boost Medtronic’s annual revenue to $27 billion, “will enhance [Medtronic’s] marketing muscle and hospital access, likely providing a market advantage over BCR and outnumbering BCR in terms of feet on the ground,” Wells Fargo senior analyst Larry Biegelsen wrote in a note to investors, using C.R. Bard’s stock-ticker abbreviation, BCR.
Peripheral artery disease causes veins in the legs to narrow or become blocked by fatty deposits, cutting circulation to the lower limbs and increasing the risk of heart attack and stroke. Having diabetes puts a person at a greater risk for developing peripheral artery disease, as does cigarette smoking, high blood pressure, being overweight, and having a family history of heart disease, according to the American Diabetes Association.
In cases where fatty buildup becomes severe enough to require a surgical intervention, the standard option in the U.S. has been balloon angioplasty that often includes implantation of a stent, a metal coil that springs open and holds a vein’s shape.
Drug-coated balloons are seen as alternatives to traditional balloon treatments and stents in cases of blockages in the thighs and knees arteries. A drug-coated ballon catheter is inserted through a small leg incision, threaded into the narrowed blood vessel, and precisely inflated to reopen it. The outside surface is coated with a drug called paclitaxel, which is supposed to treat the tissue and prevent the vessel from re-narrowing by minimizing scarring.
Last year, Medtronic officials presented data showing that 2.4 percent of their In.Pact Admiral patients who were treated for stenosis of the superficial femoral artery with a drug-coated balloon needed a repeat procedure within one year, compared with 20.6 percent of patients treated with a traditional angioplasty.
“This is important because a reduction … represents the avoidance of another procedure for the patient, which saves the health care system money,” Biegelsen wrote.
Global sales for drug-coated balloons are projected to rise to $617 million in 2020, and Medtronic will capture about 63 percent of that, even after other competitors’ products are introduced.