FDA approves labelling change for balloon catheter


AngioScore has announced that the FDA has approved a pre-market supplement (PMAS) labelling change for its AngioSculpt scoring balloon catheter, which means the company can now include a summary of the AGILITY boronary bifurcation trial results in the catheter’s instructions for use. 

According to a company press release, the AGILITY trial enrolled 93 patients with complex “true” coronary bifurcation lesions at nine premier interventional cardiology programs in the USA and followed these patients for nine months. Gary Gershony, co-founder and chief medical officer of AngioScore, said: “The AngioSculpt represents an alternative to conventional balloon angioplasty catheters for the treatment of challenging lesions because of its ability to achieve predictable luminal expansion and a low rate of dissection. The results of the prospective multicentre AGILITY trial demonstrated that use of the AngioSculpt was associated with a high rate of procedural success (91.4%); a low need for bailout stenting of the side-branch vessel (10.9%); and a very low rate of target lesion revascularisation (TLR) at nine months follow-up, with only one of the 93 patients (1.1%) experiencing TLR after 30 days. It is significant that the FDA has now allowed the company to present certain AGILITY trial results relating to bifurcations in its Instructions for Use.”

In January 2007, the AngioSculpt percutaneous transluminal coronary angioplasty scoring balloon catheter received FDA pre-market approval (PMA) for the treatment of haemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.