|[December 18, 2012]
St. Jude Medical Enrolls First Patient in ILUMIEN I Study to Develop Guidance for Stent Optimization
ST. PAUL, Minn. --(Business Wire)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced the first patient enrollment in its ILUMIEN I clinical
study. This observational study is designed to show the optimal way
Optical Coherence Tomography (OCT), an intravascular imaging technology,
combined with the St. Jude Medical PressureWire™
Aeris, a wireless interventional tool that measures Fractional Flow
Reserve (FFR), can guide stent implantation in patients with coronary
artery disease. The study will observe and record how physicians treat
patients while undergoing Percutaneous Coronary Intervention (PCI (News - Alert)), and
will also measure outcomes according to various procedural parameters.
Commonly known as coronary angioplasty, PCI is a non-surgical procedure
used to treat narrowed coronary arteries of the heart found in coronary
artery disease. Gathering this information will assist in establishing
guidance parameters for optimal stenting, which may result in improved
clinical outcomes for patients undergoing PCI.
"Improving patients' quality of life is our highest priority as
physicians, and if we can successfully treat our patients while
streamlining workflow, the benefit is even greater," said Dr. David
Holmes, ILUMIEN I Global Steering Committee Member and U.S. Coordinating
Investigator from Mayo Clinic in Rochester, Minn. "The ILUMIEN I study
is an important step towards guiding physician decisions during PCI,
ultimately leading to better clinical outcomes."
OCT images allow physicians to visualize and measure important vessel
characteristics for stent planning. Following stent placement, the
high-resolution images offered by OCT show precisely how the stent is
holding the artery open and whether it is positioned correctly against
the artery wall, informing treatment and follow-up strategies. When
combined with the PressureWire Aeris (News - Alert) to measure FFR, the use of OCT
potentially minimizes the need for urgent hospital visits, repeat
revascularizations or other complications.
"OCT offers a remarkably clear image from inside the coronary vessel,
which is something we haven't been able to see previously," said Prof.
William Wijns, ILUMIEN I Global Steering Committee Member and
International Coordinating Investigator from the Cardiovascular Center,
Aalst, Belgium. "Using this technology, I can assess important vessel
characteristics before placing the stent, confirm success after placing
the stent, and identify potential problem areas to quickly understand
how to best treat my patient."
The ILUMIEN I prospective, observational study will enroll approximately
500 patients at 40 edical centers around the world. Patients will first
undergo a catheterization procedure, which includes using the
PressureWire Aeris to take FFR measurements and establish the severity
of blood flow restriction to determine the level of treatment needed. In
arteries where FFR has determined that treatment is needed, OCT images
will then be collected to help inform stent selection and placement.
Following stent placement, OCT images will be collected again to help
inform the physician regarding the need for additional intervention.
Data will be collected before and after stenting, as well as throughout
the twelve month follow-up period, to understand the impact of coronary
lesion characteristics and stent deployment on patient outcomes. All
collected data will be compiled and used in determining stent guidance
parameters to achieve PCI optimization in both stable and unstable
coronary disease patients.
"Our FAME family of trials have demonstrated the compelling value of FFR
in the treatment of coronary artery disease, and we are now working with
leaders in the field to develop further evidence of OCT use and how it
can positively impact physician decision-making," said Frank J.
Callaghan, president of the Cardiovascular and Ablation Technology
Division at St. Jude Medical. "We are confident that the ILUMIEN I study
will result in establishing more efficient lab procedures for physicians
and better treatment plans for patients."
Coronary artery disease is the most common type of heart disease and
affects millions of people worldwide. It is caused by a narrowing or
blocking of the arteries due to plaque build-up that restricts blood
flow and reduces the amount of oxygen being delivered to the heart. In
time, reduced blood flow may cause cardiac ischemia (coronary narrowing
responsible for significantly obstructing the flow of blood to a
patient's heart muscle). A complete blockage can cause a myocardial
infarction, also known as a heart attack.
The St. Jude Medical ILUMIEN™
PCI Optimization System is a more advanced option that can provide
additional information and aid physicians in the treatment of coronary
About the ILUMIEN System
The ILUMIEN™ PCI Optimization System features the St. Jude
Aeris, a wireless interventional tool that measures Fractional Flow
Reserve (FFR) to evaluate the severity of blood flow blockages in the
coronary arteries, and the St. Jude Medical Dragonfly™ Catheter, a
first-to-market intravascular imaging catheter that allows physicians to
visualize and measure important vessel characteristics otherwise not
visible or difficult to assess with older intracoronary imaging
Combined, the two technologies enable the optimization of PCI procedures
by assisting physicians in identifying culprit lesions responsible for
ischemia. The technologies also provide physicians with precise
measurements of lesion dimensions, as well as vessel size and structure.
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.
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 (News - Alert), 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 December 31, 2011 and Quarterly Report on
Form 10-Q for the fiscal quarter ended September 29, 2012. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
[ Back To TMCnet.com's Homepage ]