In October 2009, cardiologists Ron Waksman and Rajbabu Prakala, from Washington Hospital Center in Washington, DC, posited that drug-eluting balloons could make balloon catheters the “comeback kid of percutaneous coronary intervention.” Balloon angioplasties, after all, have largely been outmoded by intracoronary stenting and drug-eluting stents. Their prediction appears to be ringing true.
“Drug-eluting balloons are the next big thing in vascular interventions,” Rajagopalan says. “With the first FDA approval in 2014, the global market for this product is likely to double in the next few years.”
C.R. Bard nabbed the first U.S. approval of a drug-eluting balloon catheter in October with its Lutonix 035, and other companies are hot on its heels. Medtronic, for one, is targeting 2015 for approval of its much-hyped IN.PACT Admiral drug-coated balloon.