St. Jude Medical ($STJ) might not like one researcher's claims that its Riata and Riata ST defibrillator leads were not up to snuff and led to patient deaths, but Medtronic ($MDT) isn't complaining about his results. In fact, the device giant says its own analysis of the same database the Minneapolis Heart Institute Foundation's Dr. Robert Hauser reviewed concurs with his findings favoring its Sprint Quattro heart defibrillator lead over the St. Jude offering.
For the past few days, St. Jude has gone on the offensive against Hauser, demanding a retraction of his study published in the journal HeartRhythm. "Dr. Hauser's research substantially undercounted total deaths in the [FDA's] MAUDE database for Quattro Secure," the company maintains, thereby resulting in "substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead."
And mid-morning Tuesday, the company issued a statement saying it has posted information from the MAUDE database showing 377 deaths associated with the Quattro Secure lead, rather than the 62 Hauser reported. It also invited Medtronic to check out its findings.
But Medtronic is singing a different tune: Its own analysis of an FDA database confirms Hauser's findings, the company claims. "The conclusions we have reached about Sprint Quattro are consistent with what Dr. Hauser found, and we confirm his results related to Sprint Quattro," the company said in email to Reuters.
St. Jude halted sales of the Riata leads in December 2010 and sent a voluntary medical device advisory letter to doctors late last year. The letter advised them of a higher rate of insulation failures with the leads than initially reported. The FDA subsequently deemed the physician alert a Class I recall--the most serious category.
Still, St. Jude is accusing its rival of trying to vilify it over Riata, but Medtronic has refuted this allegation. "Numerous other institutions have issued case studies and manuscripts on this issue," Medtronic's Chris Garland told MassDevice. "This is very clearly not a marketing campaign; this is a serious issue with a device in the marketplace."
Garland added that St. Jude's accusation against his company isn't new. "From the very beginning of this Riata issue, St. Jude has been making claims that this is nothing more than a marketing campaign by Medtronic," Garland told MassDevice via email.
The hubbub surrounding the Hauser story sent St. Jude's stock down 5% yesterday, representing the biggest decline in the S&P 500, Barron's reports. But not everyone is down on the company's stock. "We suspect ICD lead concerns will remain on the table, or in investors' and physicians' minds, regarding the stock (potentially increasing volatility) and the company's reputational profile in general," wrote BMO Capital Markets analyst Joanne Wuensch last week, as quoted by Barron's. "However, we believe STJ can work through the issues, continue to take share, and deliver on its pipeline."