Integer's RadialSeal Introducer Kit Receives FDA and CE Mark Approvals
July 31, 2018—Integer Holdings Corporation, an outsource manufacturer, announced that it has received United States FDA and European CE Mark approvals for the RadialSeal radial access introducer. Integer's portfolio of access devices is available for distribution by medical device companies in the interventional cardiology and peripheral vascular markets.
According to the company, the RadialSeal introducer kit is founded on Integer's core technology platforms in guidewires and hemostatic introducers. The RadialSeal features a thin-walled sheath design that minimizes outer diameter while maximizing inner diameter and provided ease of sheath insertion through smooth transitions and a hydrophilic coating.