Medical devices manufacturer Osprey Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its AVERT System, designed to reduce the quantity of dye injected in patients undergoing angiogram or diagnostic heart procedures.
The Avert system comprises of a re-usable contrast modulator with easy adjustable settings for different types of contrast dyes. During heart procedures, the system’s disposable modulation reservoir loads into the contrast modulator unit and gets attached to manual injection systems used by interventional cardiologists.
The company received the FDA regulatory approval for marketing the system for ‘controlled infusion of dye’. A pivotal trial is currently being conducted by Osprey to include the ‘reduction of CIN’ tag thereby expanding the marketing claims for the product.
Osprey Medical president Mike McCormick said developing the Avert System and obtaining FDA clearance in such a short period of time is testament to the capabilities of the team at Osprey and potentially opens up further exciting opportunities for the company.
"We will shortly begin to commercialize AVERT in a controlled manner to demonstrate awareness and adoption patterns among select key opinion leading physicians," McCormick added.
The AVERT System lowered the amount of dye by approximately 40% in a pilot human clinical trial without compromising image quality.
The system is expected to be launched in the US in the fourth quarter of 2013 upon completion of inventory build-up, sales plans and development of product labels.