Final-SON - Cath Lab Laser.docx

STATEMENT OF NEED

James A. Haley Veterans’ Hospital 13000 Bruce B Downs Blvd.

Tampa, FL 33612 Neximer Laser System GENERAL: James A. Haley Veterans’ Hospital (JAHVH) located at 13000 Bruce B. Downs Blvd, Tampa, FL 33612, has a requirement for Philips LAS-100 Neximer Laser System (BRAND NAME) to provide necessary laser technology to be used during Cardiac Catheterization procedures in Cardiology Section of Medicine and Specialty Care.

BACKGROUND: JAHVH currently provides patient care for veteran patients in the Cardiac Catheterization Labs of Cardiology Department – Medicine and Specialty Care Service. The current Neximer laser system is at the end-of-life expectancy and due for replacement.

PURPOSE: Neximer lasers are image-guided excimer laser systems used in interventional cardiology to treat a range of coronary and peripheral vascular problems, as well as certain cardiac lead management issues.

SCOPE: Vendor shall provide Philips LAS-100 Neximer Laser System (BRAND NAME) that meets the physical, functional and performance of the listed salient characteristics in this section. The equipment feature is essential to the technical requirements to meet the needs of the government.

CHARACTERISTICS:

· Start-Up Time: Ready for use in less than 30 seconds

· Touchscreen guided workflows

· 360° maneuverability and small lab footprint

· Seven indications for coronary vascular

· First technology proven effective for ISR in peripheral vasculature

· Only laser technology for lead removal

· Adjustable fluence and rate settings to optimize impact on various lesion morphologies

Capabilities in Coronary atherectomy:

· In-stent restenosis (ISR)

· Moderately calcified lesions

· Ostial lesions

· Lesions that previously failed PTCA

· CTO traversable by guidewire

· Occluded SVG

· Long lesions (> 20 mm)

Capabilities in Peripheral atherectomy:

· In-stent restenosis (ISR)

· Mixed morphologies

· Uncrossable CTOs

· Long lesions

· Thrombotic lesions

Capabilities in Lead extraction:

· Manage every lead

· Adjust from 25 Hz to 80 Hz based on anatomical and procedural considerations

· Advance up to 62% more efficiently through tough binding sites

· Use up to 55% less advancement force

SOFTWARE: There are no software requirements or compatibility needs regarding this request.

TRAINING: Government will not require additional training.

WARRANTY OF EQUIPMENT: Vendor shall provide standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.