Ultrasound Agent Receives ‘Innovation’ Designation

Bracco Diagnostics Inc.’s LUMASON, a contrast enhanced ultrasound agent, has received the Innovative Technology designation from Vizient (formerly Novation), the company that serves the more than 100,000 members and affiliates of Vizient, VHA Inc., UnitedHealthcare, the Children’s Hospital Association, and Provista.

The Innovative Technology designation was based on reviews of LUMASON by hospital experts who attended Vizient’s Innovative Technology Expo in November. The annual event provides medical technology suppliers with the opportunity to demonstrate their product and gain direct feedback from onsite clinical experts and healthcare providers on the impact their products may have on improving clinical care, safety, and benefits to an organization’s care and business models.

“After reviewing Bracco Diagnostics Inc. and LUMASON at our annual Innovative Technology Expo, the hospital experts who attended agreed the product offers unique and incremental benefits over other products available on the market today, and recommended it for the Innovative Technology designation,” according to Debbie Archer, director of procurement and leader of the Innovative Technology program for suppliers.

LUMASON has been approved by the U.S. Food and Drug Administration in the U.S. for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON is also the first ultrasound contrast agent to obtain FDA approval for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients. Known globally as SonoVue, which has been marketed for over 14 years in more than 40 countries,

LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect sound waves to enhance echocardiography. With a proven safety and efficacy profile, it provides quality images and is packaged in a three-part kit that does not require refrigeration or mechanical agitation. Each kit includes a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace; a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent); and a Mini-Spike.

In late 2015, the Centers for Medicare and Medicaid Services granted “pass-through” status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (OPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under OPPS unless the product has “pass-through” status. This additional payment is unique to LUMASON among contrast agents used in ultrasound procedures.

Vizient works with member-led councils and task forces to identify and review potentially innovative products. If it is determined that a product is innovative, a contract may be awarded outside of Vizient’s competitive bid cycle.”