St. Jude’s New Optisure™ Defibrillation Lead Piggybacks Durata™ Success

St. Jude Medical, Inc. has announced the global launch of the Optisure™ Defibrillation Lead, joining the Optim™ lead family, which includes the company’s now famous Durata™ Defibrillation Lead.

Background

Followers of our pages will be familiar with the story of St. Jude’s implantable defibrillator leads. The sequence of events started with the highly publicised “externalisation” problems with Riata, the fallout from which saw a number of highly vocal medical professionals pitted against an equally vocal company response. Then came the Durata lead, with its Optim coating, which seemed (and still seems) to have cured the ills of its predecessor. Then St. Jude ended up in dispute with the supplier of said coating, Scottish company Aortech, in a bitter dispute that was finally resolved late in 2012 to the seeming satisfaction of both parties.

In the intervening period St. Jude has been assiduously building up the data set relating to its Durata lead, and the naysayers have been rendered silent.

So now, no doubt keen to enjoy the fruits of Durata’s clinical credentials, St. Jude has come up with another rendering of the design. Based on the established Durata lead design, St. Jude says the Optisure lead features additional Optim insulation at the proximal end of the lead, including under the superior vena cava (SVC) shock coil. The lead design is identical to Durata distal to the SVC shock coil.

The Optisure defibrillation lead is compatible with all of the company’s implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators,  including the company’s next-generation Ellipse™ and SJM Assura™ portfolio of ICDs and CRT-Ds. The Ellipse and SJM Assura family of devices feature the DynamicTx™ Over-Current Detection Algorithm, which automatically adjusts shocking configurations within the device to ensure the delivery of high-voltage therapy if an electrical short in one portion of the system were to occur.

In addition, the next-generation Ellipse and SJM Assura portfolio of implantable defibrillators feature low friction coating on the device, which has been demonstrated in testing to significantly reduce the friction between the device and leads. Physicians using the St. Jude Medical high-voltage system, now including the Optisure lead, have access to the most advanced portfolio of products to address commonly known causes of lead failure.

Physician comments

“The Optisure lead has a thicker layer of Optim insulation that adds additional abrasion resistance to a lead that has already demonstrated excellent safety and reliability, backed by clinical evidence from St. Jude Medical as well as large, independent, multi-center studies,” said Dr. Raymond H. M. Schaerf, a thoracic and cardiac surgeon at Providence Saint Joseph Medical Center, in Burbank, California.

Company comments

“Today’s announcement reinforces our commitment to continuous innovation across our entire cardiac rhythm management portfolio with a particular focus on system reliability,” said Eric S. Fain, group president at St. Jude Medical. “The Optisure lead builds on the proven track record of our Durata lead and Optim insulation, which is supported by a large body of evidence that will continue to grow through our active post-market registries.”

Source: St.Jude Medical, Inc., Business Wire

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