r4 Vascular nabs 510(k) for quick-inflate balloon catheter

Minnesota's r4 Vascular has secured FDA clearance for its Vector percutaneous transluminal angioplasty balloon catheter, a quick-inflate device rated for up to 30 atmospheres of pressure.

The device is designed to keep blood vessels open during hemodialysis procedures, and its novel construction will help cut back on surgery times, the company said. Vector's radiopaque striping allows it to show up under x-ray, meaning physicians don't have to use viscous contrast media to visualize it. Instead, they can apply low-viscosity saline, cutting inflation and deflation times by 50% and reducing patient exposure to radiation.

Because the device is approved for up to 30 atmospheres, it allows for greater flexibility in procedures, treating the full range of blockages by functioning as both a high- and low-pressure balloon, depending on what physicians need, according to r4.

And there may be space in the balloon catheter market for r4 to cash in on the clearance. Last month, Johnson & Johnson ($JNJ) unit Cordis recalled some of its similar devices after they failed to properly inflate, and Boston Scientific ($BSX), despite getting a CE mark, has yet to get its Emerge balloon catheter on the U.S. market.

- read r4's release