St Jude Refutes NEJM Claims About Its PMS Procedures And Durata.

St Jude Medical recently and very sensibly established a website, www.riatacommunications.com in order to provide an information source for  patients and healthcare professionals concerned about the ongoing problems and recall of its Riata and Riata ST implantable Cardioverter Defibrillator leads.

The site is also seemingly quite a good vehicle on which the company can state its case as here.

In response to criticism from an editorial which has appeared in the New England Journal of Medicine, St Jude strongly defends its post-marketing surveillance procedures and also bites back against any suggestion that its Durata lead may not be trouble free.

An excerpt states:

“First and most importantly, we take very seriously our responsibilities as a leading medical device company and treat product quality as our highest priority at St. Jude Medical. In this response, we would like to comment on the topic of our Riata silicone-only leads as we believe that there were inaccuracies and omissions in the editorial that are important to recognize in order to more fully understand this issue. Secondly, there is no evidence to suggest any similar issue with our new generation Durata lead and St. Jude Medical has the most active post-market surveillance program in the industry for these leads. We have explained these programs below as well.”

Source: St Jude Medical