Founded in 2003, AngioScore is a privately held company backed by several venture capital firms. The AngioSculpt Scoring Balloon Catheter received the CE Mark for use in the coronary arteries in September 2004. The CE Mark for use in the peripheral arteries was granted in May 2005. Outside of the US, we currently have distribution in over 10 EU countries, as well as several in Scandinavia and the Asia/Pacific region.
In September 2005, the AngioSculpt Scoring Balloon Catheter received FDA marketing clearance for balloon dilatation of lesions in infrapopliteal arteries in the US. In January 2007, our coronary Pre-Market Approval (PMA) application was approved by the FDA and a full market launch is underway. Distribution within the US is achieved through a dedicated direct sales force.
AngioScore is currently involved in several post-market clinical studies to further evaluate the AngioSculpt Scoring Balloon Catheter, including a study on the usage of the product in treating coronary bifurcation lesions. Additionally, the company is developing a drug-coated version of the AngioSculpt to spearhead its next generation product-line.
WS-1000-0003 Rev B 01/09