Recently, the U.S. Food and Drug Administration (FDA) agency
instructed medical devices major,
St. Jude Medical, Inc.
(
STJ
) to conduct a study to examine insulation failure in Riata
defibrillator leads, a thin wire used to connect cardiac
resynchronization therapy defibrillator (CRT-D) or implantable
cardioverter defibrillator (ICD) to the heart to monitor abnormal
heart rhythm.
The agency has recommended that X-rays or other imaging
alternatives should be conducted in patients who have been
implanted with the heart device to increase clinical know-how. The
FDA also recommended St. Jude to carry out post-market surveillance
studies to accumulate information regarding the risks associated
with the Riata leads for 3 years.
The FDA had issued, in late 2011, an urgent recall of the Riata
and Riata ST leads given the potential risk of serious injury or
patient death. St. Jude had stopped selling the product in 2010. As
of 2011, about 79,000 U.S. citizens had been implanted with these
leads.
Although the FDA believes that most of the leads are harmless,
despite signs of electrical conductor migration or externalization,
it is still necessary to collect data on the frequency and timing
of insulation failure to advance medical treatment and enhance
patient safety.
The FDA's scrutiny is supported by a number of studies which
have indicated that a regular checkup may identify more problems
that remained undetected earlier. However, the FDA has also
cautioned health care professionals not to remove the leads
randomly, without properly evaluating the condition of the
patient.
Earlier, St. Jude had announced early phase-one results from its
Riata Lead Evaluation Study. It was found that externalized
conductors occurred less frequently in Riata ST 7F with a small
diameter in comparison to the thicker Riata 8F leads. Management
asserted that the results were consistent with other published
studies. The company's Leads Medical Advisory Board did not make
any changes to existing patient management recommendations.
Apart from the post-market studies for Riata and Riata ST ICD
and CRT-D leads, the FDA has asked St. Jude to conduct post-market
surveillance studies on its QuickFlex LV CRT leads, QuickSite LV
CRT leads and Riata ST Optim and Durata ICD leads. In April 2012,
St. Jude had voluntarily recalled its QuickFlex LV CRT leads and
the QuickSite LV CRT leads due to insulation abrasion.
If such a trend continues and similar product recalls follow in
the future, it will negatively impact the company's goodwill and
might act as leverage for its peers such as
Medtronic
(
MDT
) and
Boston Scientific
(
BSX
) to gain market share. Moreover, we remain cautious about the
restructuring expenses within the CRM business as well as the
overall weakness in the CRM market. We currently have a Neutral
recommendation on St. Jude, along with a short-term Zacks #4 Rank
(Sell).
BOSTON SCIENTIF (BSX): Free Stock Analysis
Report
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis
Report
To read this article on Zacks.com click here.
Zacks Investment
Research