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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The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.
Abbott will pay SurModics $25m upfront and up to $67m in milestones for the exclusive right to commercialization SurVeil worldwide.
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