St. Jude Medical Inc. (STJ) has received both U.S. Food and Drug Administration (FDA) clearance and Conformité Européene (CE) Mark approval for its percutaneous coronary intervention (PCI) optimization system, OPTISTM.
OPTISTM Integrated System is the first PCI optimization system across the globe to offer optical coherence tomography (OCT) and angiography co-registration, which supports procedural decisions by providing high-resolution, 3-D OCT views of coronary anatomy while mapping the exact location of physician’s view via angiogram.
As a result, OPTISTM Integrated System is different from traditional, mobile cart-based diagnostic tools as it provides an advancement of PCI optimization through direct installation into a hospital’s cardiac catheterization laboratory, fully integrating OCT and fractional flow reserve (FFR) into PCI workflow.
The OPTIS Integrated system also integrates St. Jude Medical PressureWire FFR measurement technology to provide access to critical hemodynamic information during PCI. The system will be displayed for the first time during Transcatheter Cardiovascular Therapeutics (TCT) 2014, in Washington, D.C.
PCI, or coronary angioplasty, is a non-surgical procedure. It is designed to alleviate coronary blood flow blockages and restore blood flow to the heart. Earlier, physicians have relied on angiography or intravascular ultrasound to guide PCI.
St. Jude Medical has combined OCT and FFR technology in the ILUMIEN OPTIS and OPTIS Integrated systems to enable a more detailed, physiological and anatomical analysis of blood flow blockages inside the coronary arteries.
OPTIS Integrated upgrades PCI optimization by offering a side-by-side view of OCT and angiography via co-registration to “map” culprit lesions and provide the visual data necessary to guide stent selection and deployment. Further, FFR technology allows physicians to assess the severity of blood flow blockages.
More on FFR Technology
Recently, St. Jude Medical revealed that a multi-center clinical trial showed that its Fractional Flow Reserve (FFR) technology is capable of changing the course of treatment for more than 22% of patients, who are suffering non-ST segment elevation myocardial infarction (NSTEMI) heart attacks – the most common form of acute coronary syndrome.
The data also revealed that FFR-guided PCI is safe and helpful in reducing procedure-related myocardial infarctions in NSTEMI patients over angiography alone. This apart, it indicated a trend toward a reduction in procedure-related myocardial infarction among patients whose therapy was guided by FFR using St. Jude Medical PressureWire technology.
NSTEMI is the primary cause of premature morbidity and mortality across the globe. St. Jude Medical’s FFR technology enables physicians to judge the severity of blood flow blockages in the coronary arteries and identify the lesions that require treatment. Prior clinical studies have already showed that St. Jude Medical’s FFR technology can improve patient outcomes and reduce medical costs in patients with stable coronary artery disease.
Zacks Rank
Currently, St. Jude Medical carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), Abaxis, Inc. (ABAX), and Symmetry Medical, Inc. (SMA). ICU Medical sports a Zacks Rank #1 (Strong Buy), while both Abaxis and Symmetry Medical carry a Zacks Rank #2 (Buy).
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