St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that the U.S. Food and Drug Administration
(FDA) has classified its voluntary medical device advisory letter
to physicians from Nov. 28, 2011, regarding the performance of
Riata® and Riata® ST Silicone Defibrillation Leads, as a Class I
Recall.
The classification of this recall is part of the process that
follows any medical device advisory issued by a device manufacturer
to physicians. The FDA’s classification updates the recommendations
provided in the Nov. 28, 2011 Physician Advisory Letter, which is
available on the company’s website, www.sjmprofessional.com. An
estimated 79,000 Riata and Riata ST family of silicone leads remain
active in patients in the U.S. The company stopped distributing the
Riata and Riata ST family of silicone leads in December 2010. The
affected model numbers are the Riata (8F) Silicone Endocardial
Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572,
1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr)
Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002,
7010, 7011, 7040, 7041, and 7042).
The FDA has classified this recall as a Class I recall because
of the potential risk of serious injury or patient death if
affected devices malfunction. As communicated in the Physician
Advisory Letter, the clinical implications of externalized
conductors in a defibrillation lead without electrical anomalies
are not fully known or understood at this time. Externalized
conductors can present as only a visual observation on x-ray or
fluoroscopy without any associated clinical or device-related
observations. If the electrical integrity of a lead were to be
compromised, failure to deliver appropriate therapy, or the
delivery of inappropriate therapy, could potentially occur, and
could lead to a serious adverse event or death. Reports to St. Jude
Medical associated with extraction of a Riata lead with
externalized conductors include two patient deaths and one serious
injury (effusion requiring thoracotomy). In addition, one patient
death and one serious injury in patients with externalized
conductors were reported, but were determined not to be due to the
presence of externalized conductors.
St. Jude Medical reiterates that all leads with an externalized
conductor, with or without an associated electrical abnormality, be
reported to the company’s Technical Services Department at
1-800-722-3774. The company strongly encourages that any experience
with screening of Riata leads for externalized conductors be shared
with the company, including information regarding a lead or leads
in which externalized conductors are not present. If a lead has
been removed from the patient, St. Jude Medical requests that it be
returned to the company, at company expense, for failure analysis
to further understand this particular failure mechanism. All
reports and returns received by St. Jude Medical of Riata leads
exhibiting externalized conductors, irrespective of whether there
is an associated electrical abnormality, are reported to FDA as a
Medical Device Report (MDR). Any adverse reactions experienced with
the use of this product, and/or quality problems also should be
reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088,
by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600
Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website
at www.fda.gov/medwatch.
St. Jude Medical acknowledges that the clinical implications of
leads with electrically intact externalized conductors are not
fully known at this time. Consequently, more data are required in
order to assess if specific patient subgroups with electrically
intact externalized conductors are at greater risk or should be
managed differently. Patients who require frequent defibrillation
or who are pacemaker dependent may be considered to be at greater
risk. It is recognized that physicians may choose to individualize
the approach to management of electrically intact externalized
conductors based on individual patient characteristics. The
potential risks associated with externalized conductors as well as
the potential risks and benefits of management options should be
considered and discussed with patients.
“At this time, no blanket statement can be made about clinical
recommendations. Until more data are collected, physicians should
follow standard practice of care to manage their patients with
Riata silicone leads,” said Dr. Anne Curtis, professor and chair of
Medicine at the University at Buffalo, former Heart Rhythm Society
(HRS) president and a member of St. Jude Medical’s Medical Advisory
Board (MAB). Also, over the next several weeks, there are two
public meetings scheduled to discuss Riata and associated clinical
recommendations: A Riata Leads Issue Webinar sponsored by the Heart
Rhythm Society on Dec. 21, 2011 and a Riata ICD Lead Summit
sponsored by the Minneapolis Heart Institute Foundation on Jan. 20,
2012. Any additional consensus opinion developed from these
meetings, including any additional screening efforts, will be
addressed by St. Jude Medical and, if appropriate, will be
communicated to the physician community.
The company and its independent MAB have recommended the
following related to patient monitoring:
- For leads that do not exhibit
externalized conductors, continue to monitor the patient’s
implanted system at regularly scheduled visit intervals every three
to six months as per Heart Rhythm Society (HRS)/European Heart
Rhythm Association (EHRA) consensus with particular attention to
diagnostic information related to defibrillation lead
performance.
- For leads that exhibit externalized
conductors with no electrical abnormality, continue to monitor lead
and system performance as per HRS/EHRA guidelines. The value of
screening x-ray or fluoroscopy for patients with leads that exhibit
no electrical abnormalities is unknown at this time and therefore,
the risk of increased radiation exposure for monitoring should be
weighed against using remote monitoring and in-clinic follow-up for
detection of electrical anomalies. Prophylactic explant or
replacement of a lead without electrical dysfunction is not
recommended.
- For leads that exhibit externalized
conductors with an associated electrical abnormality, management of
the patient may include x-ray, fluoroscopy (cine), or additional
testing including provocative methods such as shoulder and arm
movements and deep respiration while looking at the surface ECG and
intracardiac electrograms(1). Consideration should be given to
prophylactically replacing leads with observed electrical
abnormalities. If the leads are replaced, the risks and benefits of
removing the old leads, or leaving them in place, should be
carefully considered.
- Currently there is no expert consensus
regarding whether patients undergoing pulse generator replacement
should undergo fluoroscopy or lead replacement if an externalized
conductor without electrical anomalies is present. This is, in
part, because the risk versus benefit of replacing a lead in such a
patient may vary from patient to patient and center to center.
Consideration of fluoroscopy and lead replacement at time of pulse
generator replacement should be individualized based on specific
patient conditions and circumstances.
St. Jude Medical strongly encourages that whenever possible,
remote monitoring and patient alerts be used to detect as early as
possible any electrical changes that may be associated with
externalized conductors. Changes in impedance from three high
voltage lead vectors (RVC to Can, SVC to Can, and RVC to SVC), as
well as pacing and sensing electrodes, can be detected by St. Jude
Medical ICDs and provided to the clinician during the in-clinic
device evaluation and may also be provided by means of remote
monitoring (Housecall+, Merlin@Home, and Merlin.net). Data are
displayed graphically to enable physicians to trend changes in
impedance over time. Customized DirectAlerts® notifications allow
physicians to monitor patient status between follow-ups. The noise
reversion feature is designed to protect against non-physiologic
high-rate event detection to avoid inappropriate shocks. Standard
reprogramming such as turning on the EGM for Noise Reversion or
ensuring that the ventricular rate EGMs are set to detection should
also be considered. A patient may also become aware of electrical
abnormalities even earlier when their device has a patient
vibratory alert. Patients who receive a patient vibratory alert
should contact their clinician.
In order to improve the understanding of this particular failure
mechanism, St. Jude Medical has initiated a prospective study to
evaluate the incidence rate and the long term performance of leads
found to exhibit externalized conductors without an associated
electrical abnormality, including an evaluation of any potential
long term degradation of the ETFE insulation that is exposed
outside of the silicone insulation. Enrollment has begun and is
expected to continue to follow patients for up to two years. As
information is gathered during this study, St. Jude Medical will
update the physician community and, as appropriate, provide any
specific updated recommendations for physicians to manage their
patients.
St. Jude Medical is committed to keeping customers informed
about product performance. If you have any questions or concerns,
please do not hesitate to contact your local St. Jude Medical
representative or the St. Jude Medical Technical Services
Department at 800-722-3774.
1) Epstein, A.E. “Troubleshooting of
Implantable Cardioverter-Defibrillators.” Clinical Cardiac Pacing,
Defibrillation, and Resynchronization Therapy, 3rd ed., Eds.
Ellenbogen, K.A., Kay G.N., Lau, C-P., Wilkoff, B.L., Philadelphia:
Elsevier, 2007, pp. 1063-1086.
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. St. Jude Medical is headquartered in
St. Paul, Minn. and has four major focus areas that include:
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made
by the Company are based upon management’s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control
and the risk factors and other cautionary statements described in
the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the
Company’s Annual Report on Form 10-K for the fiscal year ended
January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 2, 2011. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
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