Thursday, May 21, 2015

BUSINESS WIRE: New data confirm clinical benefit of OCT … – Finanztreff

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Two new high current clinical studies have shown: OCT imaging method has an impact on clinical decision-making and contributes to better health outcomes during PCI in

ST. PAUL, Minnesota (USA) and PARIS – (BUSINESS WIRE) – 21/05/2015 –

St. Jew Medical, Inc. (NYSE: STJ), an international medical technology company, has announced the preliminary results of ILUMIEN I study as well as the final results of clinical ILUMIEN II trial today. Taken together, the results of both studies suggest that the optical coherence tomography imaging can (OCT) with up to ten times higher resolution than intravascular ultrasound (IVUS) help to improve the selection and insertion of stents to support clinical decision-making better and to improve the treatment results.

Data from both studies were presented today as a highly topical clinical trials within the EuroPCR 2015 and drive the use of OCT imaging in addition to percutaneous coronary intervention (PCI) even further.

At PCI procedures doctors use in diagnostic imaging, to make decisions with respect to the stent size and to assess how the artery best kept dilated and blood flow can be restored to the heart. For patients, this visualization is important because an inappropriate stent size to injuries around the vascular tissue may result, while too low a distention in the future to blood clotting (thrombosis) or a new blood vessel constriction can result.

Now data from the ILUMIEN I study showed that the before and after PCI performed OCT imaging has influenced the decision of the doctors at 65 percent of all patients and in the context of a lower number of myocardial infarction (MI), commonly known as heart attack, are. The ILUMIEN II study showed that the OCT method achieved a similar level of stent dilatation or insertion of the stent can be supported as well as the total IVUS. The stent dilatation is considered as an important sign of negative patient outcomes in PCI patients, such as blood clotting (thrombosis) or renewed restrictions in blood flow (restenosis).

“The clinical trials ILUMIEN I and ILUMIEN II provide important additional data and information on the already existing clinical evidence supporting the use of OCT imaging method for optimizing the PCI, “said the chief medical officer of St. Jew Medical, Mark Carlson. “These studies confirm the important contribution of the OCT to PCI treatment planning makes, and show a relationship between the OCT imaging procedures and improved treatment results.”

Results from ILUMIEN I: Optimization of PCI by the OCT method

As part of the largest ever prospective study to evaluate the impact of the OCT in clinical decisions and the associated outcomes, ILUMIEN I , 418 patients were examined who suffer from stable or unstable angina or non-ST elevation myocardial infarction-(NSTEMI). The annual data of the study show the following:

  • When performing the OCT process either before or after PCI, the decision of the doctors changed in 65 percent of patients
  • .

  • Before the PCI OCT resulted in 55 percent of patients in a change in treatment plan and changes in the decisions on stent length and diameter.
  • The OCT imaging was associated with a reduction in the number of MIs in the hospital when it was applied before and after PCI, to modify the intervention strategy.

“Many physicians suspect for a long time that the higher resolution of the OCT may be supportive for the treatment planning and the PCI process engineering, and the ILUMIEN I study is another important step towards the confirmation that the OCT may contribute to perfecting the PCI, “said William Wijns, Co-Director of the Cardiovascular Center in Aalst, Belgium

Results from ILUMIEN II:. assessment of stent dilatation using the OCT process

The ILUMIEN II study was to determine geared whether the OCT method a comparable degree of stent dilatation the result has as the IVUS imaging. After an analysis of the OCT-guided or guided stenting of IVUS to 940 patients from the studies I ILUMIEN and ADAPT-DES has been found that the degree of stent dilatation at OCT and IVUS imaging was comparable. The data of the study that the OCT and IVUS procedures beyond stood with a comparable number of essential stent malposition, Gewebeprotrusionen and dissections of the stent ends in connection.

“The results of related ILUMIEN II to achieve long-standing questions about the ability of OCT method, a comparable stent dilatation, precise measurements and a higher level of vascular visualization as imaging tools of the first generation, such as IVUS, “said Prof. Dr. med Gregg W . Stone, professor of medicine from the Columbia University Medical Center and chairman of ILUMIEN II study. “At present, the results of angiography performed, the IVUS-guided and the OCT-guided stent implantation within the prospective, multicenter, randomized study ILUMIEN are now III: OPTIMIZE PCI evaluated.”

About the optical coherence tomography imaging

In the OCT technology from St. Jew Medical is an intravascular imaging tool that uses light to provide anatomical pictures of the disease morphology and for automated measurements , Use the OCT technology enables doctors to visualize and measure that are not assessed in other ways visible or difficult with the older imaging technology major blood vessel characteristics. Consequently, the OCT deliver automated high-precision measurements that will be helpful in the selection and deployment of stents and in the assessment of stent placement and so able to ensure a successful intervention. The need for repeated revascularization can be potentially minimized.

About St. Jew Medical

St. Jew Medical is an international medical technology company that is committed to a change in the treatment of some of the most costly epidemic disease in the world. The company does so cost-effectively by developing medical technology that saves and improves the lives of patients worldwide. St. Jew Medical is headquartered in St. Paul, Minnesota, operates in four priority areas: cardiac rhythm management (Cardiac Rhythm Management), atrial fibrillation (atrial fibrillation), cardiovascular system (Cardiovascular) and neuromodulation. For more information, please visit, or follow us on TwitterSJM_Media.

Forward-Looking Statements

This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. 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 the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the control of the company and the risk factors and other cautionary statements described in the Company’s filings with the Securities and Exchange Commission, for example in the sections “Risk Factors” and “Cautionary Statements “in the Company’s Annual Report on Form 10-K for the year ended January 3, 2015 and the Quarterly Report on Form 10-Q for the quarter to April 4, 2015. The Company does not intend to update these statements and undertakes under no circumstances to send anyone such an update.

The original language in which the original text of this announcement is the official, authoritative version. Translations are provided as an accommodation. Only the language version, which was published in the original is valid. Equal to Thus Translations with the original language of publication from

St. Jew Medical, Inc.
J. C. Weigelt, +1 651-756-4347
Investor Relations
Justin Paquette, +1 651-756-6293
Public Relations


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