Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Medtronic's In.Pact drug-eluting balloons: Firm's ongoing In.Pact drug-eluting balloon catheter clinical trial program will enroll a total of 1,500 patients via a combination of company-sponsored and physician-initiated studies, the company says. Medtronic announced Sept. 28 initiation of a 150-patient European study of its In.Pact Admiral paclitaxel-eluting balloon to treat superficial femoral artery disease, and the firm also plans a U.S. study of the indication. Six-month data from a recent 23-patient, investigator-initiated German study of the firm's In.Pact Falcon paclitaxel-eluting balloon for treatment of coronary in-stent restenosis showed in-stent late lumen loss of "just 0.07 mm ... indicating a minimal degree of tissue growth inside the stented segment of the treated vessel," the company said. Both devices, which gained European CE-mark clearance in 2009, feature FreePac hydrophilic coating that "frees and separates paclitaxel molecules, facilitating their absorption into the vessel wall to mitigate re-narrowing of the artery," Medtronic explains
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