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PCI Optimization Portfolio

OPTIS™ integrated system angio co-registered optical coherence tomography (OCT)

Portfolio Overview

  • Combining the power of fractional flow reserve (FFR) and accuracy of optical coherence tomography (OCT) to identify and treat coronary lesions
  • Providing comprehensive insight to make informed treatment decisions



KNOW WHAT TO TREAT

AND HOW TO TREAT

​Only St. Jude Medical offers a portfolio that combines both FFR and OCT technologies to optimize treatment decisions. 


OCT in Your Lab: Use It Daily 

The on-demand OPTIS™ integrated system fits seamlessly into your cath lab, eliminating setup time and providing tableside control of OCT and FFR acquisition and review from the sterile field.

OCT is not a research tool for us—it's an everyday tool with clinical utility... If you want to be precise and target the lesions exactly and deploy your stents with a very high level, OCT has become our default [imaging] modality.
—Dr. Jonathan M. Hill

Watch the video to hear Dr. Hill talk about integrating OCT into his everyday clinical practice, then learn more about using the OPTIS integrated system.


Clinical Evidence: The Use of FFR and OCT to Optimize PCI

Based on numerous clinical studies and assessments, St. Jude Medical™ OCT systems have been proven to improve decision-making and efficiency and procedural effectiveness in pre-stent planning and post-stent assessment.2,9-13  And, compared to angiography alone, FFR has been shown to more accurately identifies hemodynamically relevant stenoses, thus reducing rates of death, myocardial infarction and repeat revascularization.1

A recent clinical compendium summarizes evidence supporting the use of FFR and OCT to optimize percutaneous coronary intervention (PCI). See the compendium.

In addition, a thorough pre-procedural lesion assessment studied the use of OCT with angio co-registration in PCI and showed that it enables accurate device sizing, selection of the vessel segment requiring treatment, as well as efficient planning of the implantation strategy. See the assessment.

Watch what physicians say about the power of fractional flow reserve (FFR) and accuracy of optical coherence tomography (OCT) to identify and treat coronary lesions, and see more clinical evidence for OCT and FFR.

Sample OCT image: malapposed stent struts with early tissue coverage

Our optical coherence tomography (OCT) systems incorporate the most technology for enhanced anatomical assessment and PCI optimization.

Sample OCT image: two edge dissections

Our optical coherence tomography (OCT) systems incorporate the most technology for enhanced anatomical assessment and PCI optimization.

Sample OCT image: circumferential calcium

Our optical coherence tomography (OCT) systems incorporate the most technology for enhanced anatomical assessment and PCI optimization.

Sample OCT image: white thrombus at side branch

Our optical coherence tomography (OCT) systems incorporate the most technology for enhanced anatomical assessment and PCI optimization.

Drawing of two arteries in the heart with arrows showing direction of blood flow

Transforming the Treatment of Cardiovascular Disease

Cardiovascular disease is the leading cause of death for both men and women worldwide, with billions of dollars spent globally on its diagnosis, management and treatment.17,18 An estimated 7.3 million people worldwide die each year from coronary artery disease alone.19 Our vision is to transform the treatment of cardiovascular disease by creating cost-effective technologies that save and improve lives. 

Learn more about our approach to cardiovascular disease.

REFERENCES

The color gold is a trademark of St. Jude Medical, Inc. and its related companies.
1. Tonino, P. A., De Bruyne, B., Pijls, N. H., Seibert, U., Ikeno, F., van’t Veer, M., ... Fearon, W. F.;  FAME Study Investigators. (2009). Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. The New England Journal of Medicine, 360(3), 213-224. http://dx.doi.org/10.1056/NEJMoa0807611
2. De Bruyne, B., Pijls, N., Kalesan, B., Barbato, E., Tonino, P. A., Piroth, Z., ... Fearon, W. F. (2012).  Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. The New England Journal of Medicine, 367(11), 991-1001. http://dx.doi.org/10.1056/NEJMoa1205361
3. Pijls, N. H., van Schaardenburgh, P., Manoharan, G., Boersma, E., Bech, J-W., van’t Veer, M., ... de Bruyne, B. (2007). Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. Journal of the American College of Cardiology, 49(21), 2105-2111. http://dx.doi.org/10.1016/j.jacc.2007.01.087
4. Nissen, S. E., & Yock, P. (2001). Intravascular ultrasound: Novel pathophysiological insights and current clinical applications. Circulation, 103(4), 604-616. http://www.ncbi.nlm.nih.gov/pubmed/11157729
5. Dijkstra, J., Koning, G., & Reiber, J. H. (1999). Quantitative measurements in IVUS images. International Journal of Cardiac Imaging, 15(6), 513-522. http://link.springer.com/article/10.1023/A:1006334517720
6. St. Jude Medical. ILUMIEN™ OPTIS™ PCI Optimization System Instructions for Use, OPTIS™ Integrated System Instructions for Use,  ILUMIEN™ PCI Optimization System Instructions for Use. 
7. Volcano Corporation, R-100™ Instructions for Use. 
8. Boston Scientific Corporation, Galaxy™ Instructions for Use. 
9. Kubo, T., Imanishi, T., Takarada, S., Kuroi, A., Ueno, S., Yamano, T., … Akasaka, T. (2007). Assessment of culprit lesion morphology in acute myocardial infarction: Ability of optical coherence tomography compared with intravascular ultrasound and coronary angioscopy. Journal of the American College of Cardiology, 50(10), 933-939. http://dx.doi.org/10.1016/j.jacc.2007.04.082
10. Tearney, G. J., Regar, E., Akasaka, T., Adriaenssens, T., Barlis, P., Bezerra, H. G., ... Weisz, G. (2012). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: A report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. Journal of the American College of Cardiology, 59(12), 1058-1072. http://dx.doi.org/10.1016/j.jacc.2011.09.079
11. Kubo, T., Akasaka, T., Shite, J., Suzuki, T., Uemura, S., Yu, B., ... Zhang, S. (2013). OCT compared with IVUS in a coronary lesion assessment: The OPUS-CLASS study. Journal of the American College of Cardiology: Cardiovascular Imaging, 6(10), 1095-1104. http://dx.doi.org/10.1016/j.jcmg.2013.04.014
12. Allahwala, U., Cockburn, J., Shaw, E., Figtree, G. A., Hansen, P. S., & Bhindi, R. (2015). Clinical utility of optical coherence tomography (OCT) in the optimisation of Absorb bioresorbable vascular scaffold deployment during percutaneous coronary intervention. EuroIntervention, 10(10), 1154-1159.  http://dx.doi.org/10.4244/EIJV10I10A190
13. Prati, F., Di Vito, L., Biondi-Zoccai, G., La Manna, A., Tamburino, C., Burzotta, F., ... Albertucci, M. (2012). Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: The Centro per la Lotta contro I’Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention, 8(1), 823-829. http://dx.doi.org/10.4244/EIJV8I7A125
14. Layland, J., Oldroyd, K. G., Curzen, N., Sood, A., Balachandran, K., Das, R., ...  Berry C.; FAMOUS-NSTEMI investigators. (2015). Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: The British Heart Foundation FAMOUS–NSTEMI randomized trial. European Heart Journal, 36(2), 100-111. http://dx.doi.org/10.1093/eurheartj/ehu338
15. Engstrom T. (2015, March). The Third DANish study of optimal acute treatment of patients with ST-segment elevation myocardial infarction: PRImary PCI in MULTIvessel Disease—DANAMI3-PRIMULTI. Presented at the meeting of the American College of Cardiology, San Diego, CA.
16. ClinicalTrials.gov. A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease (FAME 3). Identifier: NCT02100722. https://clinicaltrials.gov/ct2/show/NCT02100722?term=NCT02100722&rank=1
17. Centers for Disease Control and Prevention. Heart disease facts. Retrieved from http://www.cdc.gov/heartdisease/facts.htm
18. Bloom, D. E., Cafiero, E. T., Jané-Llopis, E., Abrahams-Gessel, S., Bloom, L. R.,
Fathima, S., ... Weinstein, C. (2011). The global economic burden of noncommunicable diseases. Presented at the meeting of the World Economic Forum, Geneva, Switzerland. http://www.hsph.harvard.edu/program-on-the-global-demography-of-aging/WorkingPapers/2012/PGDA_WP_87.pdf
19. World Health Organization (WHO). (2011). Global status report on noncommunicable diseases 2010. Geneva, Switzerland. http://www.who.int/nmh/publications/ncd_report_full_en.pdf
20. Thoratec Corporation. (2015). HeartMate PHP Instructions for Use. Pleasanton, CA.

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