Technology | July 09, 2012

r4 Vascular Announces Clearance of PTA Balloon

July 9, 2012 — r4 Vascular Inc. announced clearance from the U.S. Food and Drug Administration (FDA) to market the Vector percutaneous transluminal angioplasty (PTA) balloon catheters in 28 sizes. All Vector balloon catheter sizes are rated for up to 30 atmospheres of pressure and are radiopaque when deflated or inflated.

Vascular narrowings, lesions and blockages range from short and focal, to long and diffuse. Some lesions can be treated with basic low- pressure balloon catheters rated between 10 and 20 atmospheres, while other blockages may require advanced high-pressure balloons rated up to 30 atmospheres. High-pressure balloons are used to treat the full range of blockages, saving the physician and patient from the difficulties of initiating the procedure with a low-pressure balloon only to find out during the procedure that a high-pressure balloon is necessary.

High-pressure PTA balloons are used to keep hemodialysis access sites open for dialysis treatments, to restore blood flow in the legs, to dilate narrowings in renal (kidney) arteries and dilate lesions in other vessels throughout the body. The majority of PTA procedures are performed under X-ray fluoroscopic guidance.

r4’s patent pending Vector balloon catheter also includes radiopaque stripes on the balloon so physicians do not have to use viscous contrast media to visualize the balloon under X-ray. Instead, clinicians may use low-viscosity saline that reduces inflation/deflation time up to 50 percent and may reduce X-ray exposure to the patient and clinicians. Vector includes advanced catheter shaft technology to improve catheter tracking and handling.

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