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Market & Industry Briefs

Brief summaries of recent medtech market and industry developments. This month we cover use of fractional flow reserve PCI to avoid unecessary stenting; new European Society of Cardiology guidelines that should increase the use of implantable loop recorders; treating obesity with neurostimulation devices; Asthmatx's positive recommendation from an FDA panel; and the decrease in the number of 510(k) clearances.

One study that attracted a good deal of interest at the recent Transcatheter Cardiovascular Therapeutics (TCT) meeting was the FAME (Fractional Flow Reserve versus Angiography for Guiding PCI [Patients with Multivessel Coronary Artery Disease) Trial, presented during a late-breaking trials session. FAME assessed the use of fractional flow reserve (FFR), a guidewire-based tool that provides a physiologic measure of the severity of a stenosis by comparing blood flow at the distal and proximal ends of a lesion. FFR gives physicians an indication of which lesions are functionally significant in terms of restricting blood flow in the vessel, something that is not always evident from their appearance on angiography. The PressureWire Aeris FFR System used in the study was developed by Radi Medical Systems, which was acquired by St. Jude MedicalInc. in December 2008. [See Deal] The system is integrated into GE Healthcare/General Electric Co.'s Mac-Lab Hemodynamic Recording System, which displays, measures, and saves the FFR data. Volcano Corp., a leader in intravascular ultrasound (IVUS) imaging, also offers an FFR guidewire, PrimeWire Pressure, as part of its imaging consoles.

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