Response Submitted to PACE Affirming Performance of Riata Leads

St. Jude Medical has submitted a response to an editorial in Pacing and Clinical Electrophysiology (PACE) citing perforation concerns with its Riata family of leads. St. Jude’s article is expected to be published in the December issue of PACE.

The company’s response includes data from its returned product analysis, as well as from previously unpublished active, prospective registries showing the incidence rate of perforation with Riata is below or at the low end of what has been reported in the clinical literature for incidences of perforation for transvenous defibrillation leads, it said.

“Perforations are attributable to one or a combination of factors, including patient characteristics, the design characteristics of the lead and implant techniques,” according to Roger Freedman, director of clinical cardiology at the University of Utah Health Sciences Center and a member of the St. Jude Medical Independent Leads Medical Advisory Board.