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Bard Buys Lutonix For Lead In Race To U.S. Market With Drug-Coated Balloon

This article was originally published in The Gray Sheet

Executive Summary

Deal worth up to $325 million makes Bard first in line to enter the U.S. market with a drug-coated balloon. Firm anticipates PMA submission for Moxy in 2014.

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Medtronic, Bard In Close Race To First FDA-Approved Drug-Eluting Balloon

Medtronic says it reached the necessary trial enrollment to support PMA approval for its IN.PACT Admiral drug-eluting balloon catheter to treat atherosclerosis in the superficial femoral artery. On the same day, CR Bard said it was prepared to submit its final PMA module for its Lutonix drug-eluting balloon by year’s end.

Drug-Coated Balloons Fuel Multibillion-Dollar Hopes

With a total market potential estimated in the multibillion-dollar range, the drug-coated balloon opportunity is attracting a growing list of competitors, including several leading multinational cardiovascular device companies that have entered the space via recent acquisitions. DCBs still need to prove their worth in large, long-term clinical trials, but the ultimate proving point for DCBs could center on cost: if they can offer an effective treatment option that is significantly less expensive than existing devices, DCBs may provide a compelling economic argument.

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