Coronary Clinical Brochure

Product catalog summary

Overview: The document discusses the AngioSculpt Scoring Balloon Catheter by AngioScore, Inc., focusing on its effectiveness in treating complex coronary artery lesions. It highlights data from various studies and publications, emphasizing the device's safety and efficacy.

Specifications: The catheter is designed to treat significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, to enhance myocardial perfusion.

Clinical Success: The device has shown a 98.5% procedural success rate and a 97.5% clinical success rate, with minimal balloon slippage and greater luminal gain compared to traditional methods.

Study Data: The document cites 9 studies and 37 publications from 53 international sites, involving 1,075 patients and 1,362 lesions, noting low dissection rates and significant luminal gain.

Publications: Research has been published in prominent journals such as the American Journal of Cardiology and the Journal of the American College of Cardiology.

Contraindications and Warnings: The catheter is not suitable for lesions unsuitable for percutaneous revascularization or coronary artery spasm without significant stenosis. Antiplatelet and anticoagulant therapy is advised during and after procedures.

Conclusion: The AngioSculpt device is a reliable and effective tool for interventional cardiology, with extensive clinical validation supporting its use in complex coronary interventions.

Device Usage and Specifications: The device is for single use only and should not be resterilized or reused. For de novo or in-stent restenosis lesions, the balloon's diameter should match the vessel diameter near the stenosis. Pre-dilating before stenting requires a catheter one size smaller than the vessel diameter.

Procedures and Recommendations: PTCA in patients unsuitable for coronary artery bypass graft surgery requires careful consideration. Manipulate the catheter under high-quality fluoroscopic observation, ensuring the balloon is fully deflated before advancing or retracting. Do not exceed the rated burst pressure during inflation, and use a pressure monitoring device to prevent over-pressurization. PTCA should be performed only in hospitals equipped for emergency coronary artery bypass graft surgery.

Precautions: Extra care is needed near freshly deployed stents, especially drug-eluting stents. Verify catheter functionality before use. Only trained physicians should use the catheter. Avoid excessive rotation of the catheter shaft and luer hub. If resistance is felt, remove the catheter system carefully.

Possible Adverse Effects: Potential adverse effects include death, heart attack, artery occlusion, dissection, perforation, rupture, tamponade, no/slow reflow, emergency CABG, stroke, pseudoaneurysm, restenosis, unstable angina, thromboembolism, arrhythmias, severe blood pressure changes, spasm, hemorrhage, need for transfusion, surgical repair, arteriovenous fistula, drug reactions, allergic reactions to contrast medium, and infection.

Contact Information: AngioScore, Inc., 5055 Brandin Court, Fremont, CA 94538. Tel: 510.933.7900, Fax: 510.933.7901, Toll-Free: 877.264.4692, Email: [email protected]. Federal law restricts this device to sale by or on the order of a physician. US Patent No. 7022104 granted and other patents pending. © 2013 AngioScore, Inc. All Rights Reserved.

Catalog excerpts

Scoring Balloon Catheter

Open the catalog to page 1

Let’s clear a few things up.

Open the catalog to page 2

Multiple studies have shown that AngioSculpt® is a plaque modification tool that delivers excellent outcomes. Studies Published in Leading Journals. American Journal of Cardiology Catheterization and Cardiovascular Interventions Cardiovascular Revascularization Medicine Circulation Journal of the American College of Cardiology Journal of Invasive Cardiology International Journal of Cardiology Endovascular Forum Vascular Heart and Vessels “The AngioSculpt device is very deliverable and effective in the treatment of complex lesion morphologies. It is associated with low complication and dissection...

Open the catalog to page 3

AngioSculpt works. 98.5% Procedural Success + 97.5% Clinical Success. Mooney M, Teirstein P, Moses J et al. Final results from the US 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 Larger Luminal Gain. 33% greater luminal gain vs. conventional POBA balloon, 50% vs. direct stent. AngioSculpt has shown in 5 key studies to deliver a greater luminal gain than other pre-dilatation techniques, regardless of plaque morphology: Soft, Calcific, Fibrotic and Mixed. +50% vs. direct stent Costa JR. Mintz...

Open the catalog to page 4

AngioSculpt Peer Reviewed Publications ABSTRACTS 1. Gershony G, Virmani R, Lotan C, Konstantino E, Leon MB. A Novel Angioplasty Catheter For The Treatment Of Complex CAD: AngioSculpt. American Journal of Cardiology September 2003; Vol. 92, Issue 6, Supplement 1: 166L. 2. Abizaid A, Feres F, Gershony G, Konstantino E, Staico R, Mattos L, Vaz V, Ferreira E, Silva CE, Sousa E. Results of the First in Man Study of the AngioSculpt™ Scoring Balloon Catheter. Catheterization and Cardiovascular Interventions May 2004; Vol. 62, Issue 1:117. 3. Abizaid, A, Grube E, Gershony G, Feres F, Mueller R, Staico...

Open the catalog to page 5

Contact your AngioScore® sales representative to find out more about our peer-reviewed publications. AngioScore, Inc. 5055 Brandin Court, Fremont, CA 94538 www.angioscore.com Tel: 510.933.7900 Fax: 510.933.7901 Toll Free: 877.264.4692 [email protected] CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. ML-1120-0001 Rev B 12/13 US Patent No. 7022104 granted and other patents pending. © 2013 AngioScore, Inc. All Rights Reserved.

Open the catalog to page 6

Coronary Clinical Brochure

Coronary Clinical Brochure

Catalog excerpts

All AngioScore catalogs and technical brochures