Vector PTA balloon gets FDA clearance


The US Food and Drug Administration (FDA) has given clearance to r4 Vascular to market its 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.

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 visualise the balloon under x-ray (fluoroscopy). Instead, clinicians may use low-viscosity saline which reduces inflation/deflation time up to 50% and may reduce x-ray exposure to the patient and clinicians. Vector includes advanced catheter shaft technology to improve catheter tracking and handling.