New Data Further Emphasize the Clinical Benefits of St. Jude Medical’s OCT Technology
May 20 2015 - 4:19AM
Business Wire
In two new late-breaking clinical trials, OCT imaging guidance
was found to influence clinical decision-making and support
improved patient outcomes during PCI
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced preliminary results from the ILUMIEN I
trial and final results from the ILUMIEN II clinical study. Taken
together, the findings from both studies show that with resolution
up to 10 times higher than intravascular ultrasound (IVUS), optical
coherence tomography (OCT) imaging can help improve stent selection
and deployment, better support clinical decision-making and improve
patient outcomes.
Data from both studies were presented today as late-breaking
clinical trials at EuroPCR 2015, and further advance the use of OCT
imaging alongside percutaneous coronary intervention (PCI).
During PCI procedures, physicians use diagnostic imaging to make
decisions related to stent sizing and to assess how to best keep
the artery expanded to restore blood flow to the heart. For
patients, this visualization is important, as inappropriate stent
sizing can induce trauma to surrounding vascular tissue, while
under-expansion can lead to future clotting (thrombosis) or a
recurrence of vessel narrowing (restenosis).
Now, data from the ILUMIEN I study has revealed OCT imaging
conducted pre- and post-PCI influenced physician decision-making in
65 percent of patients and is associated with reduced rates of
myocardial infarction (MI), commonly known as heart attacks. The
ILUMIEN II study found that OCT guidance can yield a similar degree
of stent expansion, or support full stent deployment, in comparison
to IVUS. Stent expansion is viewed as an important predictor of
adverse outcomes for patients undergoing PCI, such as blood
clotting (thrombosis) or the recurrence of blood flow restriction
(restenosis).
“The ILUMIEN I and ILUMIEN II clinical studies provide important
additional data and information to the body of clinical evidence
supporting the use of OCT imaging guidance to optimize PCI,” said
Mark Carlson, M.D., chief medical officer at St. Jude Medical.
“These studies validate the important contribution of OCT in PCI
treatment planning, and show a correlation between OCT imaging
guidance and improved patient outcomes.”
Findings from ILUMIEN I: Optimizing PCI
with OCT Guidance
In the largest prospective study to date examining OCT’s impact
on clinical decisions and their associated outcomes, ILUMIEN I
assessed 418 patients suffering stable or unstable angina or non-ST
segment elevation myocardial infarction (NSTEMI). The study’s
12-month data shows:
- OCT guidance conducted either pre- or
post-PCI altered physician decision-making in 65% of patients.
- Pre-PCI OCT altered treatment planning
in 55% of patients and led to changes in decisions related to stent
length and diameter.
- OCT imaging was associated with a
reduction of in-hospital MI when used pre- and post-PCI to
change the procedural strategy.
“Many physicians have long suspected that OCT’s higher
resolution could support treatment planning and PCI procedural
technique, and the ILUMIEN I study is another important step toward
confirming OCT can contribute to the perfection of PCI,” said
William Wijns, M.D., Ph.D., co-director of the Cardiovascular
Centre in Aalst, Belgium.
Findings from ILUMIEN II: Gauging Stent
Expansion Achieved with OCT Guidance
The ILUMIEN II study was designed to determine whether OCT
guidance results in a comparable degree of stent expansion as IVUS
imaging. After an analysis of OCT-guided stenting or IVUS-guided
stenting in 940 patients from the ILUMIEN I and ADAPT-DES studies,
the degree of stent expansion was found to be comparable between
OCT and IVUS imaging. The study’s data shows OCT and IVUS guidance
were also associated with comparable rates of major stent
malapposition, tissue protrusion and stent edge dissection.
“The results of ILUMIEN II address long-standing questions
regarding the ability of OCT guidance to achieve comparable stent
expansion, more precise measurements and a greater level of
vascular visualization than first generation imaging tools such as
IVUS,” said Gregg W. Stone, M.D., professor of medicine, Columbia
University Medical Center and Study Chairman of Ilumien II. “Now,
the results of angiography-guided, IVUS-guided and OCT-guided stent
implantation are currently being evaluated in the prospective,
multicenter ILUMIEN III: OPTIMIZE PCI randomized trial.”
About Optical Coherence Tomography Imaging
St. Jude Medical’s OCT technology is an intravascular imaging
tool that uses light to provide anatomical images of disease
morphology and automated measurements. With OCT technology,
physicians can visualize and measure important vessel
characteristics that are otherwise not visible or difficult to
assess with the older imaging technology. As a result, OCT can
provide automated, highly-accurate measurements that can help guide
stent selection and deployment and assess stent placement to help
ensure successful procedures. This can potentially minimize the
need for repeat revascularization.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer
dedicated to transforming the treatment of some of the world’s most
expensive epidemic diseases. The company does this by developing
cost-effective medical technologies that save and improve lives of
patients around the world. Headquartered in St. Paul, Minn., St.
Jude Medical has four major clinical focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com or
follow us on Twitter @SJM_Media.
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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 4, 2015. 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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St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorJustin Paquette, 651-756-6293Public
Relationsjpaquette@sjm.com
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