We've written before about the ongoing problems in the cardiac rhythm management (CRM) device market. It's a mature market, and there's not much happening in the way of device innovation. As a result, the big companies in this market?Medtronic, St. Jude Medical, and Boston Scientific?are already bracing for a decline.
St. Jude's problems continue to be bigger than that though. After substantial controversy surrounding the safety of its Riata implantable cardioverter defibrillator (ICD) leads, the company is now facing more investigation over its next-generation Durata leads. In a recent inspection, the FDA found 11 problems
at the St. Jude plant that manufactures the Durata leads, including with its design verification testing procedure and risk analysis. Moreover, the company has been blamed with trying to hide potential manufacturing problems
with Durata leads by releasing a redacted version of the FDA report erasing all mentions of Durata.
It seems that St. Jude just can't catch a break. Unsurprisingly, the company's shares plummeted following this announcement, and Medtronic and Boston Scientific's futures looked a bit rosier, at least in the short term, as customers looked toward them for their CRM device needs?we expect that the impact of this announcement will be felt by St. Jude, but not by the entire industry. Nonetheless, St. Jude's history in this field is extensive, and goodwill can potentially be restored. The company's renal denervation, atrial fibrillation, and neurovascular business segments are also doing well, so its stock is expected to rebound. In the coming months, however, it will be interesting to follow the trajectory of the Durata and what strategy St. Jude will employ in dealing with this situation.