Despite Lead Problems, St. Jude Stands by Product

An editorial in a medical journal has revealed that St. Jude Medical’s defibrillator leads perforated the hearts of four patients. The case studies, accompanied by an editorial, reportedly appeared on the Web site of Pacing and Clinical Electrophysiology (PACE). Despite this news, St. Jude is standing by its Riata leads and hasn’t issued a recall on the product. The company instead responded by submitting an article to PACE, which is expected to appear in the journal’s December issue. St. Jude’s article points to data that the company hopes will affirm the strong performance of the Riata leads. According to the summary of the article, the occurence of perforations in the Riata product is “comparable or below” what has been seen for standard right ventricular pacing leads that are being followed in the company’s OPTIMUM patient registry.