Fractional flow reserve guidewires or pressure guidewires are used to measure blood flow through cardiac lesions for assessment of angioplasty or coronary artery stenting. Fractional flow reserve is the pressure of a blood flow through coronary artery in presence of stenosis. Pressure guidewires help physicians to measure this fractional flow reserve and decide if percutaneous coronary intervention (PCI) is needed. Pressure guidewires are designed to navigate the coronary artery to reach lesion. European Society of Cardiology has recently given Class I A recommendation for pressure guidewires. Over the past few years, use of pressure guidewires has increased due to adoption of ischemia guided coronary intervention approach for percutaneous coronary intervention. Global pressure guidewires market is expected to gain traction owing to entry of new players such as ACIST Medical Systems, Boston Scientific Corporation and Opsens Medical Inc. Cost effective nature of fractional flow reserve approach over other approaches also makes it a best choice by patients and physicians.
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The global market for pressure guidewires is expected to be driven by increasing number of coronary angioplasty procedures, growing prevalence of coronary artery disease and atherosclerosis, adoption of minimally-invasive techniques due to expanding aging population etc. Backing of pressure guidewires with convincing clinical data obtained through FAME trials which evaluate the efficiency of fractional flow reserve guided percutaneous coronary intervention against conventional therapy would further fuel the global market for pressure guidewires. However, stringent regulatory requirements for pressure guidewires is the prominent factor limiting the growth of global pressure guidewires market. According to US FDA and EU classification of medical devices, pressure guidewires are classified under Class III medical device.
Until 2011, the global market for pressure guidewires consisted of two player viz. St. Jude Medical and Volcano Corporation. Several companies recently obtained FDA approvals for new pressure guidewire products and several companies are nearing commercialization in future.
Based on end user, the global pressure guidewires market has been classified as hospitals, ambulatory surgical centers and cardiac catheterization labs. Hospitals end user segment is expected to hold maximum share in the global market owing to requirement of advanced healthcare infrastructure for conducting PIC procedures
On the basis of regional presence, global pressure guidewires market is segmented into five key regions viz. North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America is expected to lead the global market for pressure guidewires owing increasing number of minimally invasive PIC procedures. Europe is expected to hold second largest market share in global pressure guidewires market due good reimbursement policies in countries such as Spain and Nordic countries. Asia Pacific market for pressure guidewires is expected to grow at significant CAGR over the forecast period owing to increasing adoption of fractional flow reserve approach for PIC over traditional approaches.
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Some of the players operating in global pressure guidewires market are Boston Scientific Corporation, St. Jude Medical, Opsens Medical Inc. and Koninklijke Philips N.V. (Volcano Corporation). St. Jude medical provides PressureWire Certus and PressureWire Aeris. Philips provides pressure guidewires (acquired from Volcano Corporation in 2015) under the brand name of Verrata and Primewire Prestige PLUS which can be used along with Volcano’s intravascular ultrasound (IVUS) imaging system. In 2015, Opsens Medical Inc. received FDA approval for its OptoWire pressure guidewire. Boston Scientific Corporation recently entered into pressure guidewires market with its Comet FFR Guidewire.
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