CVX-300 and CVX-300-P
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Vascular Intervention and Lead Management EXCIMER LASER SYSTEM Spectranetics excimer laser technology treats complex cardiovascular conditions through the unique mechanism of pulsed photoablation. Indicated treatments using the CVX-300 and excimer laser catheters include removing lesions comprising atheroma, fibrosis, calcium, thrombus, and neointimal hyperplasia in the coronary and peripheral vasculature and include transvenous removal of problematic pacing and defibrillator leads. Operators—both physicians and hospital staff—can anticipate an easy-to-use system with simple set-up. The Spectranetics excimer laser platform coupled with excimer laser catheters is indicated for use in several applications within the minimally invasive interventional cardiovascular market. Spectranetics Vascular Intervention markets and sells the excimer laser platform and disposable laser catheters to interventional cardiologists and radiologists and vascular surgeons for the following Indications for Use in both peripheral and coronary interventional procedures: Peripheral Procedures • Treatment of infrainguinal stenoses and occlusions • Critical Limb Ischemia (CLI) • Total occlusions crossable by guidewires Coronary Procedures • Moderately calcified stenoses • Occluded saphenous vein bypass grafts Spectranetics Lead Management provides the excimer laser platform and disposable laser sheaths for transvenous removal of chronically implanted pacing and defibrillator leads. • Long diffuse disease • Restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy Lead Management Procedures • Lesions that previously failed balloon angioplasty • Laser-assisted lead removal has an established safety profile and has proven effective in multiple clinical trials1,2 • Balloon-refractory and balloon-resistant lesions • Ostial lesions Additionally, the laser and fiber optic catheter system has FDA-cleared individualization of treatment for the following: • In coronary procedures, excimer laser treatment may be considered in the presence of acute myocardial infarction, acute thrombus, and ejection fraction of less than (<) 30% • In peripheral procedures, excimer laser treatment may be considered if a guidewire crossing attempt is unsuccessful, the proximal occlusion cap deflects the guidewire into a subintimal path or collateral branch, and if calcification obstructs the complete passage of the guidewire through the lesion • Additionally, in peripheral procedures, recanalization of native arteries may be considered when presented with occluded bypass grafts For more information, visit www.spnc.com • The laser sheath enables fast and predictable lead removal procedures1 • Laser technology enables higher success rates than mechanical sheaths1 1 Wilkoff, Bruce L., et al. (May 1999). Pacemaker Lead Extraction with the Laser Sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, 33, 6. 2 Byrd, Charles, et al. (May 2002). Clinical Study of the Laser Sheath for Lead Extraction: The Total Experience in the United States. Journal of Pacing and Electrophysiology, 125, 5.

Vascular Intervention and Lead Management CVX-300® and CVX-300-P® EXCIMER LASER SYSTEM Excimer Laser System Maintenance The CVX-300 Excimer Laser System is a precision instrument that will provide years of service with a very low failure rate when properly serviced and maintained. Spectranetics offers a full-complement of factory-certified service options for the laser to meet our customers’ needs. These programs, designed with our customers in mind, eliminate the need for institutions to purchase any specialty tools or equipment required for servicing. SERVICE LEVEL ANNUAL CUSTOMER...