SurModics Resumes TRANSCEND Trial Of SurVeil Drug-Coated Balloon
Executive Summary
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.
You may also be interested in...
FDA Panel To Address Paclitaxel Safety Concerns
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.
SurModics Recruits Abbott To Commercialize SurVeil Drug-Coated Balloon
Abbott will pay SurModics $25m upfront and up to $67m in milestones for the exclusive right to commercialization SurVeil worldwide.
Minute Insight: Abbott Rolls Out Navitor Next-Gen TAVR System To Catch Up To Medtronic And Edwards
Navitor is an upgraded version of Abbott’s Portico TAVR system with a better fabric cuff and large curved aortic “cells” to reduce the risk of injury to the native valve.