FDA Clears r4 Vascular’s Vector™ High Pressure PTA Balloon

In short

r4 Vascular, Inc. has announced FDA clearance 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. r4’s proposition is why start with a low pressure balloon if there’s a chance you’re going to need something a bit more capable.

High-pressure PTA balloons have a variety of uses, from keeping haemodialysis access sites open for dialysis treatments, to restoring blood flow in the legs, dilating narrowings in renal arteries or other vessels throughout the body.

The majority of PTA procedures are performed under x-ray fluoroscopic guidance and often rely on use of high viscosity contrast media. r4 says its balloon possesses radiopaque stripes on its surface, so usually only requires low-viscosity saline in order for it to be visualised. The company claims this reduces inflation/deflation time by up to 50% and may reduce both patient and clinician x-ray exposure.

Vector™ includes advanced catheter shaft technology to improve catheter tracking and handling.

Source: r4 Vascular Inc., Business Wire