|An independent study found that St. Jude Medical's Durata ICD leads were safe and effective after 5 years.--Courtesy of St. Jude Medical|
St. Jude Medical's ($STJ) much-scrutinized defibrillator leads remained almost 100% safe from abrasion and mechanical failure after 5 years, according to an independent analysis, results the company hopes will quiet alarm from regulators and competitors.
The Population Health Research Institute pooled data from three registries on Durata and Riata ST Optim, finding the leads had a 99.9% rate of freedom from all-cause insulation abrasion and a 99.4% rate of freedom from all-cause mechanical failure.
Both leads are outfitted with Optim polymer insulation, licensed from AorTech, and St. Jude has said the technology prevents the dangerous corrosion that led to patient deaths and a global recall of the original Riata in 2011. Now, with independent validation of its results, St. Jude has some backup for its long-held assertion of the leads' safety.
"We are pleased that PHRI's independent analysis of our Optim-insulated lead registries continues to demonstrate the excellent safety and reliability of our Durata ICD leads," Chief Medical Officer Mark Carlson said in a statement.
But that might not be enough to dull the damage already done. The FDA hit St. Jude with a warning letter over its manufacturing practices at a Durata-making plant in California earlier this year, and Medtronic ($MDT) sponsored a study finding that St. Jude's prized insulation can break down in the body after 6 years, leaving patients at risk.
St. Jude is facing investor lawsuits over how it handled the warning letter, with shareholders claiming the company willfully withheld that the FDA's action related to Durata. Meanwhile, St. Jude has spoken out against Medtronic's study, questioning its methodology and pointing to internal data supporting a long lifespan for the leads.
A few analysts have speculated that Durata may endure its own recall in the near future, but St. Jude has wasted no time in fighting back against the worry, and getting an independent co-sign on Optim's reliability is a step in the right direction.
- read the statement