FDA clearance for Osprey Medical's DyeVert PLUS

Company News

Osprey Medical (ASX:OSP) has received US FDA 510(k) clearance for its DyeVert PLUS Contrast Reduction System.

This new platform adds to its current technology with the capability to actively manage dye administration during coronary interventions.

DyeVert PLUS received European CE Mark in 4Q 2016.

The company said it further validated its dye savings capabilities through initial market testing with multiple physicians in Germany and Italy, which showed a 44 per cent contrast reduction.

The product received strong positive feedback on the utility of real-time contrast monitoring and ease of-use. Through wireless communication, the system interfaces with a 'smart syringe' and reusable LCD monitor.

Osprey said it expects the DyeVert PLUS system will accelerate sales in 2017 with the added value of displaying dye savings per injection and per case.

“The monitoring of dye is a valuable feature, especially in a patient with impaired kidney function – you know exactly where you are at each point during an intervention,” said Professor Steffen Desch of the Heart Centre in Lubeck, Germany.

Osprey’s President and CEO, Mike McCormick, added: “DyeVert PLUS is a substantial upgrade for our customers and we will thus transition all current users on to this next generation product. This exciting new product further supports our long term company vision: to make heart imaging procedures safer for patients with poor kidney function.”