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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CSI markets minimally invasive devices to remove vascular plaques and has a full pipeline of complementary vascular intervention technologies. Abbott expects CSI’s products to complement its existing coronary intervention business and expand its presence in the peripheral market.
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.