Medical devices major,
St. Jude Medical Inc.
) has enrolled the first patient for its Ilumien I clinical
study. The study is intended to guide physicians about the
optimal way to use the Ilumien integrated Fractional Flow Reserve
(FFR) and Optical Coherence Tomography (OCT) platform to treat
coronary artery diseases.
The Ilumien study will enroll roughly 500 patients in 40
centers across the world. The results of the observational study
will be used to develop stent guidance parameters to accomplish
Percutaneous Coronary Intervention (PCI) optimization and enhance
OCT is an intravascular imaging technology used by doctors for
high resolution imaging of vessel structures in numerous coronary
interventions. The FFR technology, an index that identifies and
measures the severity of coronary artery narrowing, can be
measured by St. Jude's PressureWire Aeris, a wireless
The ILUMIEN PCI Optimization System from St. Jude, featuring
the unique OCT-FFR combination, provides cardiologists with
comprehensive information to assess and determine the lesions
that warrant coronary interventions, resulting in better
treatment outcomes. The Ilumien system received both the Food and
Drug Administration (FDA) and CE Mark approvals in 2011.
St. Jude reckons FFR and OCT, the two exciting emerging
technologies, as the most important growth drivers in its
vascular business. While the company is battling pressure in the
Implantable Cardioverter Defibrillator (ICD) market due to the
Durata lead issue, we believe that positive results from the
Ilumien I clinical trial should boost the Cardiovascular and
Ablation Technology Division at St. Jude.
However, the company continues to have a substantial market
share in the worldwide CRM market along with
Boston Scientific Corporation
). St. Jude has maintained a robust growth rate over the past
decade. We believe that new product development and penetration
into emerging markets will drive long-term growth for the
We currently have a long-term 'Neutral' recommendation on St.
Jude, which carries a short-term Zacks #3 Rank (Hold rating).
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