ASAHI INTECC CO., LTD. announces a Chronic Total Occlusion (CTO) indication for its Corsair, Corsair Pro Microcatheters and its Coronary Guide Wires to include MIRACLEbros series, CONFIANZA series, FIELDER series and Gaia series. This marks a significant milestone as it is the first expanded indication for ASAHI devices in the United States.
CTO’s are common findings in patients with coronary artery disease. A CTO is defined as complete occlusion of a coronary vessel for at least 3 months. CTO’s in major coronary arteries continue to present significant obstacles to complete percutaneous revascularization and are a common reason for patients to be referred to coronary artery bypass grafting (CABG) procedures. CTO’s are identified in approximately 20% of patients with coronary artery disease who get a diagnostic coronary angiogram. The CTO indication was awarded to ASAHI from the FDA on February 12, 2018 (FDA 510k# K171933). The indication was supported by clinical data from the ASAHI-CTO trial – a prospective, single-arm, multicenter trial examining procedural and in-hospital outcomes among patients undergoing attempted CTO PCI at 12 centers in the United States (US). The study included 163 patients and tracked both technical and procedural success.
The study had the most complex patients studied to date as indicated by an exceptionally long total stent length (63.7mm ± 30.6mm), 46.8% of patients with a JCTO score ≥ 3 and 50.3% of patients having moderate/ severe calcification in the target artery. Dr. David Kandzari, Director Interventional Cardiology and Chief Scientific Officer at Piedmont Heart institute said, “In a trial representing the highest complexity among chronic total occlusion trials, these results reaffirm the high success rates that are achievable with contemporary methods and among experienced programs. In addition to the regulatory approval of ASAHI guide wires and Microcatheters, we also welcome the educational opportunity these study results bring to raising awareness and advancing competency in the treatment of complex coronary disease.”
ASAHI will be working closely with physicians to provide education to support minimally invasive treatments for patients with CTO’s. Dr. Aaron Grantham, Associate Professor of Medicine at the University of Missouri and Director of Cardiovascular Medicine at St. Lukes Health Center said, “We are pleased that we could provide the FDA with the information needed to gain approval for a host of devices that have revolutionized the approach to coronary chronic total occlusions and we look forward to further collaborations with ASAHI as we continue to educate the interventional community on best practices on this field.”
For Further Information
More on the interventional cardiology market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Interventional Cardiology Devices. This report covers the following market segments: coronary stent, coronary balloon catheter, balloon-inflation device, interventional coronary catheter, interventional coronary guidewire, coronary embolic protection device, coronary atherectomy device, coronary thrombectomy device, chronic total occlusion system, introducer sheath, coronary vascular closure device, diagnostic coronary catheter and guidewire, intravascular ultrasound (IVUS) and optical coherence tomography (OCT).
The iData series on the market for interventional cardiology covers the U.S., Japan, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about interventional cardiology device market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Interventional Cardiology Devices brochure and synopsis.