St. Jude Medical (St. Paul, Minnesota) had high hopes for its Optim coating process for the Riata ST and Durata lines of leads for implantable cardioverter defibrillators, but according to an article appearing in a European cardiology journal, these leads have failed a conspicuous number of times after four years or less, including the Durata, seen as the lead that would fix all that ails the Riata ST. The news applies yet more pressure on St. Jude, which was recently informed by FDA that it would have to conduct post-market 522 studies on the leads (Medical Device Daily, Aug. 17, 2012), a requirement the firm may yet be able to fulfill with ongoing post-market studies of the devices. Read More
