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FDA allows radial access introducer on US market
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Integer announced that a radial access introducer for patients undergoing PCI received approval from the FDA, in addition to a CE Mark approval.
The introducer kit (RadialSeal, Integer) provides treatment flexibility through a thin wall sheath design to minimize the outer diameter while maximizing the inner diameter, according to a press release from the company. Smooth transitions and hydrophilic coatings aid in sheath insertions.
“We set out to build upon our proven hemostatic introducer and guidewire technologies to develop a robust radial introducer portfolio ranging from 4F to 6F to address the needs of the interventional cardiologists,” Andrew Senn, vice president of product solutions for Integer, said in the release. “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.”
The radial introducer kit is available for use in the United States, according to the press release.
Disclosure: Senn is an employee of Integer.