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.

Four new-generation cardiac computed tomography (CT) scanners from leading diagnostic imaging companies are recommended in draft guidance from NICE’s Diagnostics Assessment Programme.

The provisional recommendations support the use of the following CT scanners in the NHS:

• Somatom Definition Flash CT (Siemens Healthcare)
• Aquilion ONE (Toshiba Medical Systems)
• Brilliance iCT (Philips Healthcare)
• Discovery CT750 (GE Healthcare).

The draft NICE guidance recommends the use of these CT scanners for first-line imaging of coronary arteries in people with suspected coronary artery disease who are difficult to image with earlier-generation CT scanners and who are considered at high risk (10–29%) of having the disease.

It also recommends their use in people with known coronary artery disease for first-line evaluation of disease progression to establish the need for surgical intervention where use of earlier-generation scanners is difficult.

Recent NICE guidelines on acute chest pain recommend CT (as well as invasive) coronary angiography to diagnose coronary artery disease in people considered at high risk (10–29%) of the disease.

However, people with complicating factors such as a high calcium score, obesity, arrhythmias, tachycardia or previous coronary stents or grafts, are difficult to image using earlier CT technologies.

The new-generation cardiac CT scanners listed above have superior technical features enabling faster image acquisition, better image quality and lower radiation dose.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The independent Diagnostics Advisory Committee concluded that new-generation cardiac CT scanners are good value for money for hard to image patients instead of proceeding directly to initial angiography.

“The Committee acknowledged that, from a patient perspective, a non-invasive cardiac diagnostic test is preferable to invasive coronary angiography because of the risks associated with this type of test.”

The draft guidelines are now open for consultation with healthcare professionals, industry and patient groups. NICE is particularly keen, Professor Longson said, to discuss “this important new technology” in relation to the existing NICE guidelines on the diagnosis and management of angina.

Coronary artery disease caused an estimated 91,000 deaths in the UK in 2007.