Boston Scientific Corporation, a worldwide developer, manufacturer and marketer of medical devices, has received clearance from the US FDA to market its Peripheral Cutting Balloon microsurgical dilatation device in the United States. The Company will launch the device immediately.
The Peripheral Cutting Balloon device features tiny, longitudinally mounted atherotomes (microsurgical blades) on the surface of an angioplasty balloon and will be used to treat patients who are currently undergoing haemodialysis for End Stage Renal Disease (ESRD). A form of kidney disease, ESRD occurs when both kidneys are impaired or functioning at less than 10 per cent of their normal rate.
Reliable access to the bloodstream three or more times a week is required to perform haemodialysis. This access must be created either through a direct connection to an artery (arteriovenous fistula) or via a graft, which involves connecting a soft, synthetic tube from the end of an artery to the end of a vein. The Peripheral Cutting Balloon device has been cleared by the FDA to treat patients with the second type of access point: the graft. A graft is typically used when patients have small or weak veins. Because of the need for repeated needle sticks during haemodialysis treatments, these access points are prone to stenosis (blockage of a vessel) that leads to decreased blood flow. In order to treat such stenosis, clinicians have traditionally used percutaneous transluminal angioplasty (PTA).
However, in many cases the high inflation pressure associated with PTA can put unwanted pressure on the vessel wall. The Peripheral Cutting Balloon device provides an innovative option to conventional angioplasty because it reduces this type of trauma on the vessel. As the balloon is expanded, the atherotomes score the lesion with precise incisions, allowing the balloon to dilate the vessel with less pressure.
The stubborn make-up of these blockages may also pose a challenge called elastic recoil. The Peripheral Cutting Balloon device scores the lesion, disrupting the fibrotic continuity of the lesion.
"This device will undoubtedly have an important role in interventional medicine, particularly for the treatment of recalcitrant stenoses which are unyielding to conventional angioplasty," said Thomas Vesely, MD of the Washington University School of Medicine in St. Louis. "Because the device scores the lesion with precise incisions, it may also prevent elastic recoil in these stubborn lesions. There also appears to be a pain benefit associated with the device, as well as a six-month long-term benefit to patients with thrombosed dialysis grafts," he added.
"The introduction of the Peripheral Cutting Balloon device shows Boston Scientific's continuing commitment to developing advanced technology for peripheral intervention," Paul LaViolette, Boston Scientific senior vice president and group president, Cardiovascular said adding, "Physicians now have a new, highly effective tool for treating the complications that can result from haemodialysis access grafts."
The Peripheral Cutting Balloon device's availability comes amid a growing prevalence of ESRD, which affects more than 500,000 people worldwide every year, nearly 400,000 of them in the US.