Healthcare Industry News:  neuromodulation 

Devices Interventional Cardiology

 News Release - May 14, 2012

St. Jude Medical Continues Strong Show of PCI Optimization Technologies at EuroPCR

New technology, symposia and a FAME II data presentation keep St. Jude Medical at the forefront of PCI Optimization

ST. PAUL, Minn. & PARIS--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced it will display a number of technologies from the company's wide array of clinical solutions and launch its next-generation PressureWire™ Fractional Flow Reserve (FFR) assessment guidewire at EuroPCR 2012. There will also be a number of St. Jude Medical-sponsored percutaneous coronary intervention (PCI) optimization symposia and a late-breaking clinical trial session on the FAME II trial.

“With the launch of ILUMIEN, and the ongoing research about our PressureWire technologies from the FAME family of trials, St. Jude Medical’s PCI optimization technologies have been some of the most talked about at EuroPCR over the past several years, and this year will be no exception,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “Our focus on improving patient care and reducing health care costs is unrelenting, which is why we’re continually supporting research to learn more about clinical and economic benefits of our PressureWire FFR measurement technology.”

FAME II Late-Breaking Trial Session

The late-breaking clinical trial session revealing new data from the FAME II clinical study will take place on Tuesday, May 15, from 15:00 – 17:25 in the main arena. Investigators will present the study design, a subset of primary endpoint data, and discuss how the study results may change physicians’ practice.

The goal of the St. Jude Medical-sponsored FAME II (Fractional Flow Reserve Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment (OMT) Alone in Patients with Stable Coronary Artery Disease) trial is to study the role of FFR in the treatment of stable coronary artery disease by comparing PCI guided by FFR plus OMT to OMT alone. Enrollment in the trial was stopped following a recommendation from the Data Safety Monitoring Board (DSMB) after they found a highly significant reduction in the need for hospital readmission and urgent revascularization when FFR-guided assessment was used to direct treatment. The DSMB considered it unethical to continue to randomize patients to OMT alone.

FFR measurement identifies the severity of narrowings in the coronary arteries and allows for a more effective assessment of coronary lesions, or blockages, resulting in more accurate diagnosis and improved appropriate treatment of coronary artery blockages.

PressureWire with Agile Tip Launch

St. Jude Medical is announcing the European launch of its latest FFR assessment technology, the PressureWire™ with Agile Tip. The next-generation of PressureWire was designed to replicate the performance of standard PCI guidewires and deliver exceptional handling even in the most challenging anatomies. Available in both the Aeris (wireless) and Certus PressureWire models, the guidewire can also deliver interventional tools more easily, for faster and more cost-effective PCI.

“The new PressureWire platform offers exceptionally easy-to-use technology and allows me to assess my patients’ coronary arteries more quickly and accurately,” said Lars Hellsten, MD, Senior Interventionalist, PCI Cath Lab at Gävle Hospital, Sweden. “I am extremely pleased with the usability and added sense of control I get with St. Jude Medical’s latest FFR technology.”

The next-generation PressureWire features symmetrical Agile Tip technology, which greatly improves steerability in tortuous anatomies, and a new proprietary hydrophilic coating that reduces friction, allowing for easier deployment of stents and coronary balloons.

St. Jude Medical Sponsored Symposia:

St. Jude Medical will sponsor two sessions focusing on PCI Optimization:
  • FAME-trials Family: Physiology, Decision-making and Clinical Outcomes Symposium, Tuesday, May 15, 17:00–18:30 in room 252AB.
  • Optimizing PCI and Patient Outcomes with Combined FFR and OCT Guidance, Thursday, May 17, 12:00–14:00 in the Theatre Bordeaux.
Attendees can visit St. Jude Medical at booth F8 and F9 found on Level 1 of the exhibition hall during EuroPCR to see ILUMIEN – the first combined FFR and OCT system, PressureWire with Agile Tip and other leading technologies.

EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), a leading international course for interventional cardiovascular specialists.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

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 December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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