New data announced at Transcatheter Cardiovascular Therapeutics 2016
confirm benefit of using St. Jude Medical OCT Technology in complex PCI
procedures
Company Website:
http://www.sjm.com
ST. PAUL, Minn. & WASHINGTON -- (Business Wire)
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced the ILUMIEN III trial met its primary endpoint
demonstrating percutaneous coronary intervention (PCI) guided by optical
coherence tomography (OCT) to be superior to angiography in stent
expansion and procedural success and non-inferior to intravascular
ultrasound (IVUS) guided-PCI in post-procedure minimal stent area (MSA).
This Smart News Release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20161030005014/en/
St. Jude Medical™ Optical Coherence Tomography (OCT) Software features automated measurements, co-registered angiography views and new stent deployment features. (Graphic: Business Wire)
Results from the ILUMIEN III study were presented today in the first
Late Breaking Clinical Trial session of the Transcatheter Cardiovascular
Therapeutics (TCT) Conference in Washington, D.C. The study enrolled 450
patients at 29 sites in eight countries. It is the first multicenter,
prospective, randomized, controlled study to date comparing OCT-guided,
IVUS- guided and angiography-guided PCI outcomes.
ILUMIEN III confirms that OCT-guided PCI:
-
Results in comparable MSA and stent expansion as IVUS-guided PCI;
-
Results in significantly greater stent expansion than
angiography-guided PCI, with greater rates of procedural success; and
-
Is superior to IVUS-guided PCI at detecting predictors of major
adverse events (major stent malapposition and dissection).
“These results provide further evidence of the importance of imaging in
PCI procedures,” said Dr. Ziad A. Ali, associate director of
translational medicine at the Columbia University Medical Center’s
Center for Interventional Vascular Therapy and a principal investigator
of the ILUMIEN III study. “Minimal stent area is widely considered the
most important factor for circumventing both early and late major
cardiovascular events. Now we know that OCT-guided PCI achieves similar
MSA results to IVUS-guided PCI and results in significantly greater
stent expansion to angiography.”
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. A key factor in
reducing stent failure is increasing the MSA and securing appropriate
stent expansion during PCI to restore blood flow, a process commonly
known as revascularization.
In the ILUMIEN III study, physicians employed the St.
Jude Medical™ OPTIS™ Integrated and ILUMIEN™ OPTIS™ PCI optimization
systems, along with the Dragonfly™ imaging catheters designed for
high-resolution imaging, to assess vessel and lesion characteristics,
size stents, and optimize stent placement in patients randomized to
OCT-guided stent implantation.
“These results demonstrate that OCT is an important imaging option to
achieve optimal stent deployment to advance the care of patients with
coronary artery disease,” said Philip Ebeling, vice president and chief
technology officer at St. Jude Medical. “Optical coherence tomography
has a superior resolution to detect predictors that can contribute to
major adverse events and thus can facilitate the treatment of those
conditions, if necessary, to minimize the likelihood of their
occurrence.”
Next year, St. Jude Medical plans to expand research that demonstrates
the long term value of OCT further. “It gives me great pleasure to
announce that St. Jude Medical recently committed to sponsoring the
ILUMIEN IV study, a global multicenter trial that will evaluate long
term outcomes in patients randomized to angiography-guided PCI alone
versus angiography and OCT-guided PCI,” said Dr. Gregg W. Stone,
professor of medicine at Columbia University, director of cardiovascular
research and education at the Center for Interventional Vascular Therapy
at New York Presbyterian Hospital/Columbia University Medical Center and
co-director of medical research and Education at the Cardiovascular
Research Foundation (CRF). “We will provide more information as it
becomes available in the coming weeks and look forward to initiating
this trial in 2017.”
About Optical Coherence Tomography Imaging
The St. Jude Medical 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 older imaging technologies. 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. Learn more about how
the OPTIS™ Integrated system works.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer and is
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 five major areas of focus that include heart failure, atrial
fibrillation, neuromodulation, traditional cardiac rhythm management,
and cardiovascular. 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, reimbursement strategies, 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
2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended
July 2, 2016. The company does not intend to update these statements and
undertakes no duty to any person to provide any such update under any
circumstance.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161030005014/en/
Contacts:
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor
Relations
jweigelt@sjm.com
or
Gina
O’Connell, 651-756-3380
Media Relations
goconnell02@sjm.com
Source: St. Jude Medical, Inc.
© 2024 Canjex Publishing Ltd. All rights reserved.