- 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.
- Costa RA, Mooney MR, Teirstein PS, et al. Final results from the multi-center trial of the angiosculpt scoring balloon catheter for the treatment of complex coronary artery lesions Cardiovascular Revascularization Medicine 7 (2006)81–126.
- AngioSculpt Test Report SR-1571 (2008).
- Zhang J et al. The ULTIMATE trial. Journal of the American College of Cardiology (2018), doi.org/10.1016/j.jacc.2018.09.013
- D051336 AngioSculpt Evo Marketing Claims Report.
- D059995 Customer Preference Study Report Evo Claims validated by clinician feedback on clinical cases performed with AngioSculpt EVO, with a sample size of 39 physicians using AngioSculpt EVO on 105 cases. Clinicians participating in the survey compared AngioSculpt EVO’s deliverability against the deliverability of their most used non-compliant balloon.
ELCA important safety information indications:
The laser catheters are intended for use either as a stand-alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (PTCA) in patients who are acceptable candidates for coronary artery bypass graft (CABG) surgery. The following indications for use, contraindications and warnings have been established through multicenter clinical trials. The Philips CVX-300 Excimer laser system and the multi-fiber laser catheter models are safe and effective for the following indications: occluded saphenous vein bypass grafts, ostial lesions, long lesions (greater than 20mm in length), moderately calcified stenosis, total occlusions traversable by a guidewire, lesions which previously failed balloon angioplasty, restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calcified material. The lesions should be well defined by angiography. Contraindications: Lesion is in an unprotected left main artery. Lesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot traverse. Guidewire cannot be passed through the lesion. Lesion is located within a bifurcation. Patient is not an acceptable candidate for bypass graft surgery. Potential adverse events: Use of the Philips CVX-300 Excimer laser system may contribute to the following complications: dissection of the arterial wall, perforation, acute reclosure, embolization, aneurysm formation, spasm, coronary artery bypass graft surgery, thrombus, myocardial infarction, arrhythmia, filling defects, death. No long term adverse effects of ELCA are known at this time. Risks: The primary endpoint defined in the laser angioplasty of restenosis stents (LARS) randomized trial was the absence of major adverse cardiac events (MACE) at 6 months: Death; myocardial infarction; coronary artery bypass surgery. Procedural complications include: any dissection, acute thrombus, haziness, no reflow, arrhythmia, acute vessel closure, occlusion of side branch, occlusion non-target, coronary spasm, coronary embolism, coronary perforation, laser/stent damage, balloon/stent damage,
and other serious. Caution: Federal law restricts this device to sale by or on the order of a physician.
Summary of safety and effectiveness – PTCA catheter 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 artery bypass (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.
Federal law restricts this device to sale by or on the order of a physician.