Integer Receives FDA Approval for Thin Wall Radial Introducer Kit, RadialSeal

Integer Holdings Corporation, a medical device outsource manufacturer, has received U.S. Food and Drug Administration and CE Mark approval for its new radial access introducer, RadialSeal. The RadialSeal Introducer Kit is founded on Integer’s core technology platforms in guidewires and hemostatic introducers, and further strengthens its portfolio of high quality access products available for distribution by medical device companies in the interventional cardiology and peripheral vascular space.
 
“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,” said Payman Khales, president of Integer’s cardiovascular division. “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 access devices.”
 
“We set out to build upon our hemostatic introducer and guidewire technologies to develop a radial introducer portfolio ranging from 4F to 6F to address the needs of the interventional cardiologists,” said Andrew Senn, vice president of product solutions. “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 RadialSeal radial introducer kit is available for use in the United States as well as Europe and other countries that recognize the CE Mark.
 
Integer Holdings Corporation is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, vascular, portable medical, and orthopedics markets. The company provides medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical, and Electrochem.