AngioSculpt RX PTCA

1. Mooney M, Teirstein P, Moses J et al. Final results from the U.S. multi-center trial of the AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary artery lesions. Am J Cardiol. 2006;98(8 suppl):121M

2. AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc.

3. Fonseca A, Costa JR, Abizaid A, et al. Intravascular ultrasound assessment of the novel AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008;20:21-27.

AngioSculpt PTCA important safety information

The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

The AngioSculpt catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a significant stenosis.

Possible adverse effects include, but are not limited to: death; heart attack (acute myocardial infarction); total occlusion of the treated artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable chest pain (angina); thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular arrhythmias); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair or vascular access site; creation of a pathway for blood flow between the artery and the vein in the groin (arteriovenous fistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection.

This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

Caution: Federal law restricts the devices referenced on this site to sale by or on the order of a physician.

Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country.

AngioSculpt RX PTCA is distributed by Biotronik in Australia and New Zealand.

Always read the label and follow the directions for use.

Philips medical devices should only be used by physicians and teams trained in interventional techniques, including training in the use of this device.

Philips reserves the right to change product specifications without prior notification.