FDA Approves Integer’s RadialSeal Guidewire

Medical device outsourcer Integer earned FDA approval for its RadialSeal radial access introducer device.

The device is for use by interventional cardiologists to increase access options to the radial artery for entry of a catheter.

The device has a thin wall sheath that is especially useful for patients with smaller arteries, and the guidewire’s tip, which has a hydrophilic coating, reduces the risk for vessel trauma and spasm.