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

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Integer Holdings Corporation (“Integer”), a leading medical device outsource manufacturer, announced that it has received FDA and CE Mark approval for their new radial access introducer, RadialSeal(TM). 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 and innovative access devices.”

“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,” 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.

About Integer(TM)

Integer Holdings Corporation is one of the largest medical devices outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, vascular, portable medical and orthopedics markets. The company provides innovative, high-quality 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(TM) Medical, Lake Region Medical(TM), and Electrochem(TM).


For Further Information

More on the peripheral vascular stent market in the U.S. can be found in a report series published by iData Research entitled the U.S. Market Report Suite for Peripheral Vascular Devices and Accessories. The suite covers reports on the following markets: Peripheral Vascular Stent Market, PTA Balloon Catheter Market, Atherectomy Device Market, Chronic Total Occlusion (CTO) Device Market, Embolic Protection Device Market, Stent Graft Market, Surgical Graft Market, Diagnostic and Interventional Catheter Market, Diagnostic and Interventional Guidewire Market, Introducer Sheath Market, Inferior Vena Cava Filter Market, Arteriovenous (AV) Access Thrombectomy Device Market, Vascular Closure Device Market, and Transcatheter Embolization Device Market.

Reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about peripheral vascular device market data or procedure data, register online or email us at for a U.S. Market Report Suite for Peripheral Vascular Devices and Accessories brochure and synopsis.

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