CE mark and US FDA approval for RadialSeal introducer kit

RadialSeal kit

Integer Holdings has received US FDA and CE mark approval for its new radial access introducer, RadialSeal. According to a press release, the RadialSeal introducer kit is founded on Integer’s core technology platforms in guidewires and haemostatic introducers. The press release states that the kit further strengthens its portfolio of high quality access products available for distribution by medical device companies in the interventional cardiology and peripheral vascular space.

Payman Khales, president of Integer’s cardiovascular division, says: “RadialSeal was designed with two performance goals in mind: optimal treatment flexibility provided by a thin walled sheath design that minimizes outer diameter while maximizing inner diameter, and ease of sheath insertion through smooth transitions and hydrophilic coating. Given the currently limited number of viable offerings in the thin-wall introducer segment of the growing radial access market, RadialSeal addresses the needs of medical device manufacturers seeking to strengthen their product portfolios with high quality and innovative access devices.”

Andrew Senn, vice president of product solutions, notes: “We set out to build upon our proven haemostatic introducer and guidewire technologies to develop a robust radial introducer portfolio ranging from 4Fr to 6Fr to address the needs of the interventional cardiologists,” said. “The thin wall sheath design increases radial access options, especially for patients with smaller arteries, while the smooth transitions and tip, combined with a hydrophilic coating, lessen friction to potentially reduce the risk for vessel trauma and spasm.”


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