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.

MedX Health’s skin imaging diagnostic systems, MoleMate and SIMSYS, have been granted FDA approval for sale in the US.

These non-invasive medical technologies use light to look beneath suspicious moles, creating accurate images to help physicians evaluate lesions, often eliminating the need for painful and expensive skin biopsies.

Steve Guillen, President and CEO of MedX Health, said: “The US market alone is estimated to be a $1 billion opportunity, and MoleMate and SIMSYS are the only FDA approved and patent protected siascopy products in this important health segment.”

MoleMate features a hand-held scanner designed for office use, providing images of the pigment, blood, and collagen below the mole or lesion.

SIMSYS allows image capture and storage as well as special features that can be used to compare moles. It will support ‘mole mapping’ in 2012, where the entire surface of the patient's skin is photographed to observe changes over time, so that suspicious moles can be monitored more closely.

Dr. R. H. Falcon, a dermatologist in New York, said: “I chose this technology because it gives me extra information about my patients’ suspicious moles and lesions through the additional views of the skin and helps me and the patients to come to a more informed decision about removal.”

Almost 13 million people in the US have a history of non-melanoma skin cancer, usually diagnosed as basal cell carcinoma or squamous cell carcinoma. The survival rate for patients whose melanoma is detected early is about 99%. This statistic falls to 15% for patients with advanced disease.

The MoleMate and SIMSYS medical technologies are already available in Australia, Europe and the UK.