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 clinical outcomes.
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 interventional tool.
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 and Medtronic Inc. . 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 company.
We currently have a long-term ‘Neutral’ recommendation on St. Jude, which carries a short-term Zacks #3 Rank (Hold rating).