• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » St. Jude Medical wins EU green light for Ilumien Optis

St. Jude Medical wins EU green light for Ilumien Optis

May 16, 2013 By Ingrid Mezo

St. Jude Medical wins EU green light for Ilumien Optis

St. Jude Medical (NYSE:STJ) today announced CE Mark approval of its Ilumien Optis PCI optimization system, designed to help physicians assess and treat patients with coronary artery disease.

Ilumien Optis will launch in Europe next week during EuroPCR, the St. Paul, Minn., headquartered company said in a press release.

"This next-generation system delivers critical information to physicians about the location and severity of disease within the coronary arteries, potentially resulting in better medical decision-making and overall cost-effective treatment," Frank Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division, said in a press statement.

Ilumien Optis launched in Japan in March. An earlier version, Ilumien, got the marketing go-ahead in 2011 in the U.S. and in Europe.

Ilumien Optis provides enhancements to the Ilumien system, including first-in-kind stent planning software tools to aid in the treatment of coronary artery disease. This new version of St. Jude’s Ilumien platform combines the company’s PressureWire Aeris wireless fractional flow reserve technology with its Dragonfly JP imaging catheter.

The FFR tech measures the flow of blood across lesions in the arteries that feed the heart muscle, so that cardiologists can determine whether a stent is needed. The OCT tech uses near-infrared light to provide images of the lesions to measure pressure inside the coronary arteries, St. Jude said.

Featuring a faster, high-powered laser, Ilumien Optis offers twice the resolution for microscopic examination of disease inside the artery to assist with stent placement, according to the company. And, 3D vessel reconstruction offers a 360-degree panoramic view of the vessel, making it easier for physicians to visualize the area they are treating. St. Jude is the only company to provide these tools together in an integrated platform, the company notes.

"OCT technology has become increasingly important to help diagnose and treat patients with
coronary artery disease," Dr. Giulio Guagliumi, Cardiovascular Department of Ospedale Papa Giovanni XXIII, Bergamo, Italy, said in a press statement.

"The Ilumien Optis system is a significant advancement in intravascular imaging technology allowing physicians to comprehensively assess more vessel in less time and more easily plan their PCI procedure," he continued. "The three-dimensional format of the ILUMIEN OPTIS system provides a more true-to-life perspective of the arteries, which allows for individual decision making and precise guidance of stent placement to optimize coronary interventions."

According to the European Heart Network, the financial burden for EU health care systems related to cardiovascular diseases was estimated at just under €110 billion in 2006, which represents around 10% of the total health care expenditure in the EU, St. Jude pointed out. About one-fifth of that health care expenditure is due to coronary artery disease, the company said.

St. Jude in December enrolled the 1st of 500 patients in the Ilumien I clinical trial of its PressureWire Aeris fractional flow reserve device. The study aims to show the best way to use optical coherence tomography during coronary angiography procedures using the PressureWire Aeris.

Filed Under: News Well, Stents Tagged With: stjudemedical

More recent news

  • Neuralink files to raise $649M in new equity offering
  • BofA: Surgical robot remanufacturing not a major setback for Intuitive
  • InspireMD wins CE Mark approval for CGuard Prime
  • Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe
  • Ceryx Medical raises $15M to support bioelectronic pacemaker

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy