SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
May 5, 2001
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Date of Report (Date of earliest event reported)
ST. JUDE MEDICAL, INC.
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(Exact name of registrant as specified in its charter)
Minnesota 0-8672 41-1276891
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
One Lillehei Plaza, St. Paul, MN 55117
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(Address of principal executive offices) (Zip Code)
(651) 483-2000
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Registrant's telephone number including area code
Not applicable
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Former name or former address, if changed since last report
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ITEM 5. OTHER EVENTS
ST. JUDE MEDICAL ADOPT-A TRIAL RESULTS REPORTED AT NASPE
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On May 5, 2001, Dr. Mark Carlson reported on the results of the ADOPT-A
study, which was sponsored by the Company, to an audience of heart specialists
in Boston at the annual meeting of the North American Society of Pacing and
Electrophysiology (NASPE).
Mark Carlson, M.D., M.A., Vice chairman, Department of Medicine,
University Hospitals of Cleveland and Associate Professor of Medicine, Case
Western Reserve University, was one of the investigators in the ADOPT-A trial.
The Atrial Dynamic Overdrive Pacing Trial (ADOPT-A) was designed to
test the efficacy of a new feature in the Company's low voltage, bradycardia
pacemakers, Dynamic Atrial Overdrive (DAO), in treating atrial fibrillation
(AF). The trial was conducted under an Investigational Device Exemption (IDE)
from the FDA because the FDA has not approved the DAO feature for commercial
release.
ADOPT-A is a randomized, controlled, single-blinded study conducted at
over 40 medical centers in the US, Canada, and the European Union. Patients
enrolled in the study received the St. Jude Medical Trilogy DR(R) or
Integrity(TM) Afx(TM) Autocapture(TM) Pacing System and were randomized into two
groups: one with the DAO algorithm ON and DDDR pacing set at 60 ppm; the other
with the DAO algorithm OFF and DDDR pacing at 60 ppm. A total of 399 patients
with confirmed, symptomatic AF were enrolled in the study with approximately 200
patients in each treatment group. The duration of the trial was approximately
two-and-a-half years.
Significant results of the ADOPT-A study reported by Dr. Carlson
include:
- Over 90% of the atrial arrythmias observed during the 6-month
follow-up period were atrial fibrillation (vs. other organized
atrial arrythmias).
- The percentage of beats that were atrial paced was
significantly greater (p<0.0001) in the DAO ON group (92.9%)
than in the DAO OFF group (67.9%), demonstrating that the
algorithm performed as specified in stimulating the patient's
atrium in a very high percentage of the time.
- Overall AF burden was 25.03% less in the DAO ON group than in
the DAO OFF group, and there was a consistent and decreasing
AF burden observed over time (p<0.05).
- When patients with no AF episodes >30 days after device
implant are excluded from both the treatment and control
groups, AF burden was 36.33% less in the DAO ON group than in
the DAO OFF group (p<0.02).
- Patients in the DAO ON group showed a 60% reduction in
symptomatic AF episodes from baseline levels, while patients
in the DAO OFF group showed a 45% reduction in symptomatic AF
episodes from baseline levels (both p<0.001).
- Quality of Life (QoL) scores for standardized physical
(p=0.013) and mental (p<0.001) components significantly
improved in the DAO ON group, while only improving to a
significant degree for the standardized mental component of
the DAO OFF group (p<0.001).
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- No DAO-related complications and no unanticipated adverse
events were recorded.
When the study commenced in 1998, the Company set a goal of a 30%
reduction in AF burden as it was defined in the protocol. In 2000, an
FDA advisory panel considering the general topic of AF suppression
algorithms in pacemakers recommended that a 25% reduction in AF burden
was an appropriate efficacy goal for clinical studies assessing such
suppression algorithms in patients with underlying bradycardia therapy
indications. The results of the ADOPT-A trial met this recommended
goal.
Approximately 55 of the 399 patients enrolled in the study have not yet
fully completed the 6 month follow-up period required by the study
protocol. It is possible that some or all of the reported results of
the study could change in a statistically meaningful manner when the
final data is collected. The Company intends to submit results of the
ADOPT-A study to the FDA as part of a submission for the Integrity Afx
Autocapture Pacing System, (Model 5346) which contains the DAO
algorithm.
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ST. JUDE MEDICAL, INC.
Date: May 7, 2001 By: /s/ Kevin T. O'Malley
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Kevin T. O'Malley
Vice President and
General Counsel
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