BSX TO GAIN ICD MARKET SHARE BECAUSE OF STJ PROBLEMS
My definition of widely reliable is a lead that is not on a class 1 recall by the FDA. WHich is the current recall on the Riata lead.
Riata is the older lead and has been out for 8 years and begins failing at about 15 percent rate at the 72 month mark Study out of Ireland shows this.
Durata the lead that they have been selling for 3 years or so is now starting to show the exact same failure mechanism "inside out abrasion" If FDA pulls the Durata lead St. Jude will have no tachy lead to sell.
My definition of reliable: not on a class 1 recall by FDA or a lead that is almost structurally identical to a lead that is on a class 1 recall (Difference between Durata and Riata is outer Optimum coating everything else the same)
Above is a link to the FDA maude database. Which shows a Durata lead that failed. This is St. Jude's current tachy lead. This was only a 38 month from implant failure. As time goes on failures will increase.
Durata is the new lead that St. Jude is trying to say will not fail like Riata. Here is documentation that the new lead is also failing.
FDA as many in the industry are watching this very closely. Few more reports like this to FDA and who knows what will happen.