“Our bi-annual product performance report is part of our commitment to providing physicians complete and accurate information so they can make decisions about how to best treat their patients”
St. Jude Medical, Inc. has released its bi-annual product performance report which extends to 266 pages and provides details of the performance of all the company’s cardiac rhythm management devices.
The company is no doubt hoping the issuance of this report speaks of its openness and thoroughness as it is prepared to publicly stand behind its products. Of course, given the hoo haa relating to its defibrillator leads however, most readers will flick straight to the Riata® summary staring on page 228. Read the full report here (pdf) or if you just want a few highlights, read on.
St.Jude’s Riata® leads are all under scrutiny for a reportedly high incidence of problems, specifically so-called externalisation. The company developed it’s polyurethane Optim® coating in a move to improve durability, this coating having been applied to later Riata ST leads and all Durata products. Data in the report speaks to all categories of lead, but we’re focusing on Riata and Riata St here.
As of February 29, 2012, there were 671 confirmed cases of externalised conductors reported to St. Jude Medical worldwide on Riata® (8F) and Riata® ST (7F)silicone defibrillation leads, equating to a 0.30% incidence rate (671 out of 226,973). Of these 671 leads, 171/671 were returned for analysis.
The majority of the increase since issuance of the Medical Device Advisory on November 28, 2011 is from non-returned leads identified during fluoroscopic screening.
The incidence rate observed for Riata 8F is 0.37% and for Riata ST is 0.13%.
St. Jude Medical states clearly that it understands that the passive complaint reporting system results in under-reporting and hence underestimates the true failure rate associated with any given failure mechanism. The company says this is especially true for “externalised” conductors since most manifest as visual anomalies only with normal electrical performance. In fact the report acknowledges that peer reviewed publications indicate that the incidence rate observed on Riata and Riata ST leads is substantially higher than the 0.30% derived from passive complaint reporting.
Focus on Durata
Clearly St.Jude is firmly of the view that its Optim polyurethane coating has done the trick as it reports on its Optim coated Riata ST and Durata models. It states in the report that “The safety and reliability of our Durata® high voltage leads is supported by robust post-market surveillance monitoring.”
The company is continuing to enrol patients with Durata or Riata® ST Optim® leads in its various prospective, outcome-oriented, actively monitored registries. These currently number 10,950 Optim-insulated leads (8,075 Durata and 2,875 Riata ST Optim leads) at 292 sites. The leads have been followed for over five years with a total of 27,477 patient-years of follow-up and the most recent data indicate freedom from mechanical failures including insulation abrasion, conductor fractures, and failures of crimps, welds and bonds to be 99.6% at five years with zero reported externalisation events.
“Our bi-annual product performance report is part of our commitment to providing physicians complete and accurate information so they can make decisions about how to best treat their patients,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “The combined registry data on our Optim leads represent the most robust post-market surveillance monitoring system in the ICD industry, which will also be independently verified by a third-party research institution. We are committed to ensuring that we deliver the highest quality devices possible.”
Source: St.Jude Medical Inc., Business Wire