SurModics Resumes TRANSCEND Trial Of SurVeil Drug-Coated Balloon

SurModics suspended the trial with their SurVeil drug-coated balloon in March after the US FDA sent a letter to physicians alerting them to possible safety problem with paclitaxel-coated devices. The company has updated the patient consent form and established a new patient follow-up program for the trial.

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[Editor's note:Complete historical information on important medical device trial announcements is available from Informa’s Meddevicetracker. For an archive of previous Medtech Insight articles on medtech clinical trials, visit the Tracking Trials page.]

SurModics Inc. announced 17 April it resumed enrollment in the TRANSCEND trial of their SurVeil paclitaxel-coated balloon for treating peripheral vascular disease.

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