AngioSculpt Evo

* Based on AngioSculpt PTCA clinical data, IFU

** Therapeutic portion (the balloon and scoring element) have not changed

1. D051336 AngioSculpt Evo Marketing Claims Report.

2. Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007;100:812-817.

3. AngioSculpt Test Report SR-1571.A (2012)

4. AngioSculpt Test Report SR-1571 (2008)

5. 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; 20:1.

AngioSculpt Evo PTCA important safety information. The AngioSculpt Evo 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 Evo 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); embolism, total occlusion of the treated coronary artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflow of treated vessel; emergency coronary arterybypass (CABG); emergency percutaneous coronary intervention; CVA/stroke/embolic stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable 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 of 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 this device 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.

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.