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.

Low-profile balloon catheter for PAD launched

by emma 21. September 2011 13:54

Coyote Balloon Catheter

Boston Scientific has launched its new balloon dilation catheter, Coyote, to treat patients undergoing peripheral angioplasty procedures below the knee.

The Coyote Balloon Catheter is intended to help physicians when treating patients who have challenging obstructive lesions in the lower extremities.

With an ultra-low profile of 0.0174 inches, it promises to be highly deliverable and offer rapid deflation.

Balloon catheters are often used during peripheral angioplasty and stenting procedures to open blocked arteries.

J. A. Mustapha, Director of Endovascular Intervention at Metro Health Hospital in Wyoming, Michigan, said: “Its performance gives me greater confidence in being able to effectively treat patients with difficult anatomy who suffer from peripheral artery disease.”

The device is the latest in a series of balloon catheter products developed by Boston Scientific.  In June, the company launched its Mustang PTA Balloon Catheter, a 0.035 inch percutaneous transluminal angioplasty (PTA) catheter designed to be used in a range of peripheral angioplasty procedures.

Jeff Mirviss, President of Boston Scientific's Peripheral Interventions Division, said the new product launch “builds on Boston Scientific's global leadership in low-profile peripheral balloon angioplasty”.

Up to 9 million US patients suffer from peripheral artery disease, which is associated with high rates of morbidity.

Boston Scientific has begun marketing the product in the US, Europe and other international markets.

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