Product Spotlight: What You Need to Know About the LUNA Fluorescence Angiography System

Information for this feature was provided by Brian D. Lepow, DPM, AACFAS, associate at Lepow Foot and Ankle Specialists, Houston, TX. Featured product: LUNA Fluorescence Angiography System. Date of product launch/release: Pre-launch occurred during fall 2012 with full launch in March 2013 at the Diabetic Foot Global Conference in Los Angeles. In honor of the launch and to highlight the winner of the 2013 Edward J. Olmos Award for Advocacy in Amputation Prevention (Lawrence B. Harkless, DPM), Novadaq presented the College of Podiatric Medicine at Western University Health Sciences (Pomona, CA), where Harkless serves as founding dean and professor of podiatric medicine and surgery, with a LUNA system for use in podiatric medical and surgical training. Product description: The LUNA Fluorescence Angiography System is the latest member of Novadaq’s SPY Fluorescence Imaging technology family of products. LUNA combines the properties of a fluorescence imaging agent called indocyanine green with unique near-infrared laser, camera technologies, and sophisticated software to produce high-quality angiographic images of blood flow in vessels and tissue perfusion. LUNA does not involve the potential safety hazards associated with ionizing radiation and traditional contrast agents, making it an ideal system for use by wound clinic staff and in patients whose kidney function may be of concern, such as those living with diabetes. The LUNA system consists of a mobile unit with an articulating arm that facilitates easy movement of the imaging head over the area of interest. Once the camera is positioned, the imaging agent (which binds to the proteins in blood and circulates naturally and quickly through the body) is administered and the LUNA system is activated. Moving images of blood flow into and out of the area of interest are captured by the camera and displayed on flat-screen monitors that are attached to the mobile unit. Images are processed, can be further analyzed using the analysis toolkit software, and are then stored for future reference and comparison. LUNA software enables the automated generation of a procedure report that can be printed and stored in the patient’s record. LUNA also allows for the capture, storage, and printing of still-color photographs with the push of a button. The system also consists of the LUNA convenience Paqs, which include all the disposable products required to perform LUNA studies in the wound care clinic. Product’s role in the wound care clinic: LUNA allows for visual assessment of blood flow quality to extremities and chronic nonhealing wounds. LUNA images can assist wound care specialists in determining the best care pathways for patients and have been reported in the literature to potentially be predictive of wound healing. The use of LUNA allows specialists to quickly and easily observe real-time, clinically relevant images of inflow and outflow of blood in an area of interest and to make critical decisions that may influence patient outcomes. The result: Patients can be more efficiently directed into the appropriate care pathways to promote healing, which ultimately can also reduce the cost of care. LUNA procedures are reimbursable and allow wound care specialists to assess and document baseline tissue perfusion on admission, define optimal care pathways based on the visual quality of blood flow, and validate and revise treatment strategies by assessing perfusion before and after therapies such as:     • vascular intervention     • hyperbaric oxygen therapy (HBOT)     • tissue debridement     • negative pressure wound applications     • skin substitutes. How is the product unique?   The LUNA system is unique in that it provides wound care specialists with a real-time, clinically relevant visual image of tissue perfusion in the extremities and chronic nonhealing wounds. Images can be acquired within approximately 2-3 minutes without causing any patient discomfort or need for sedation. LUNA imaging studies can be performed by existing wound care staff and do not require specialized personnel or additional infrastructure. Multiple imaging studies can be done if necessary during a single patient visit. Images can be stored for future reference and specialized software allows for the comparison of serial images over time, which can be critical in managing patients through certain therapies such as a series of HBOT, for example. Are there different variations/models of the product or are any planned?   No, and none are planned for the immediate future. Are there any warrant offers?   Yes, LUNA is sold as a “program,” which means customers are eligible to receive additional value beyond what is typical of other device purchases. The LUNA program fee includes clinical education and training support, marketing and reimbursement support, and technical service for the life of the program agreement. So, with the exception of gross negligence, Novadaq covers the cost of all service and maintenance of the system. Does the product come with any add-on services?   Yes, the LUNA program includes clinical and educational support services that offer trained professionals to be on-site to ensure the system is being used properly by both physicians and support staff. The LUNA program also includes the support of reimbursement experts to help ensure proper billing and coding practices are put in place to maximize reimbursement to the clinic. The Centers for Medicare & Medicaid Services have effected code C9733 to describe LUNA fluorescence angiography and have established a standard payment for the procedure as of October 2012. In addition, LUNA can assist wound care centers in differentiating themselves from other centers in their regional area. Knowing that marketing budgets are tight for both wound care clinics and hospitals, Novadaq provides turnkey marketing support and materials that are customizable and allows our customers to promote themselves as leaders in the field. Materials include news, broadcast and media releases, newsletter templates, patient education materials, referring-physician campaigns, health fair materials, and more. Novadaq can act like a silent partner or be as active as our customers would like, and we’re often asked to reach out to media and others on their behalf. Customers who have taken advantage of Novadaq’s marketing support have claimed to save thousands of dollars in expenses by not having to develop their own materials. Does the product come with any training or educational materials?   Yes, in addition to the on-site mentoring program, Novadaq provides reference guides, videos, and other materials that assist wound care specialists and their staffs to properly perform and interpret LUNA images to physician and support staff. We also provide materials to educate patients and referring physicians. Where is the product available for purchase?   The product can be purchased in the US through Novadaq’s direct-selling organization. To contact a local sales professional, call Novadaq customer service at 800-230-3352 or email customerservice@novadaq.com For additional information: Contact a sales representative or customer service associate at 800-230-3352 or customerservice@novadaq.com.