The FDA has approved Cordis Corporation’s Empira and Empira NC RX PTCA dilatation catheters for the treatment of coronary artery disease.

Both balloon catheters are designed to allow cardiologists to open patients’ narrowed coronary arteries during angioplasty procedures.

Dr Campbell Rogers, Chief Scientific Officer and Global Head of R&D at Cordis, said that the company “worked closely with physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the Empira Balloon Catheters will meet physicians' needs and has the potential to improve patient outcomes”.

The two medical devices bring several design and technology alterations to Cordis’ portfolio of Empira balloon catheters. They feature the company’s next generation Duralyn Flex balloon material, which is 50% more flexible than the material used in the current Fire Star and Dura Star RX PTCA dilatation catheters, to improve crossability and recrossability, the ability to pass through a lesion.

Cordis Corporation is a Johnson & Johnson company, and develops and manufactures interventional vascular technology. The company works with interventional cardiologists, radiologists and vascular surgeons to treat patients with vascular disease.

The products are expected to be launched for sale in early 2012.

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.