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| St. Jude won FDA approval for the new versions of its Ellipse and Assura implants.--Courtesy of St. Jude |
St. Jude Medical ($STJ) scored FDA approvals for the latest in its banner lines of implanted defibrillators, saying the new generation is less likely to scrape against leads and put patients at risk.
The newest Ellipse and SJM Assura devices are outfitted with technology that detects electrical shorts and tailors shocks to the patient, but, perhaps most importantly, St. Jude said the implants have been redesigned to cut the odds of lead abrasion, the bête noire behind Riata's recall and Durata's shaky public perception.
The devices are strapped with a proprietary low-friction coating St. Jude said can significantly reduce chafing between implants and leads, slashing the chances of external abrasion, the most common cause of lead insulation failure.
While Riata was recalled over dangerous lead failure in 2011, St. Jude reformulated its proprietary insulation for Durata, licensing a polymer from AorTech that's designed to negate the previous device's problems. Now, with the FDA's blessing to sell new implants insulated to slash abrasion rates, St. Jude is looking to further quell concerns that its devices are putting patients at risk.
Of course, it's not as if those worries are unfounded. After the Riata recall, which saddled St. Jude with costs monetary and otherwise, the company has been understandably sensitive to any publicized problem with Durata. Last week, after a journal reported that one patient's Durata lead failed after a likely insulation defect, St. Jude went on the defensive, pointing to independently verified data showing the devices to be nearly 100% safe from abrasion and mechanical failure after 5 years.
But some investors and analysts are staying cautious, considering the company's recent past. In January, the FDA served St. Jude a warning letter over its quality systems at a Durata plant in California, sending the company's stock reeling and leading investors to file a lawsuit claiming St. Jude withheld the fact that the FDA was scrutinizing Durata.
- read the announcement
Editor's note: An earlier version of this story misstated when Riata was recalled. We regret the error.