FDA Approves CTO Indication for Asahi's Corsair and Coronary Guidewires
April 2, 2018—Asahi Intecc Co., Ltd. announced that the US Food and Drug Administration has approved a chronic total occlusion (CTO) indication for its Corsair and Corsair Pro microcatheters and its coronary guidewires that include the MiracleBros series, Confianza series, Fielder series, and Gaia series. The company noted that this is the first expanded indication for Asahi devices in the United States.
According to Asahi Intecc, the CTO 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 percutaneous coronary interventions at 12 centers in the United States. The study included 163 patients and tracked both technical and procedural success.
The study's complex population included patients with exceptionally long total stent length (63.7 mm ± 30.6 mm), 6.8% of patients with a J-CTO (Multicenter Chronic Total Occlusion Registry in Japan) score ≥ 3, and 50.3% of patients having moderate/severe calcification in the target artery.
In the company's press release, David Kandzari, MD, commented, "In a trial representing the highest complexity among CTO 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 guidewires 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." Dr. Kandzari is Director of Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, Georgia.
Aaron Grantham, MD, added, "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 CTO, and we look forward to further collaborations with Asahi as we continue to educate the interventional community on best practices on this field." Dr. Grantham is Associate Professor of Medicine at the University of Missouri and Director of Cardiovascular Medicine at St. Lukes Health Center in Kansas City, Missouri.