FDA clears balloon catheters for coronary arteries

by emma 9. November 2011 11:54

Medtech FDA news

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.

Pharma pays US doctors $150m

by emma 31. August 2011 11:50

Pf industry news

Several large pharmaceutical companies have paid US physicians nearly $150m this year, according to analysis by the Financial Times.

Industry data into the controversial marketing and support practices found that $148m has been given to 165,000 doctors so far, including $48m from Eli Lilly and $42m from Pfizer.

A spokesperson for Lilly said the “collaboration with healthcare providers is essential” to improve outcomes for patients and to provide innovative medicines.

In the UK, the ABPI recently changed its Code of Practice meaning companies now have to declare payments to healthcare professionals for their services from 2013 in an attempt to increase transparency. Government agencies in the US are currently finalising similar guidelines as part of the healthcare reforms.

The analysis by the Financial Times, in conjunction with PharmaShine, is designed to allow health authorities, medical institutions and patients better scrutinise and understand the links between doctors and pharma.

But the way current disclosures are made and presented varies and makes comparisons and analysis difficult for both authorities and patients alike.

Allan Coukell, Head of the Pew Prescription Project – a US drug safety watchdog – says that healthcare professionals and the industry needs to work together for research purposes, “but the marketing model is problematic”.

“The first step is transparency and we are not even there yet,” he added.

Research found that collectively the industry paid $437m to 262,000 doctors in 2010. Among the physicians who received the highest level of support was Dr Zale Bernstein, an Associate Professor from the Roswell Park Cancer Institute in Buffalo, New York. Dr Bernstein received $234,000 in 2010 from Cephalon, Eli Lilly and Pfizer and has already received more than $57,000 already this year.

Although the majority of doctors received smaller sums, studies have suggested even modest support by pharma can affect prescribing practices.

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