Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark.
RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division. The introducer also offers easy sheath insertion through smooth transitions and hydrophilic coating, Khales added.
The device is Frisco, Texas-based Integer’s response to the limited number of viable offerings in the thin-wall introducer segment of the growing radial access market, he said.
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