Integer's RadialSeal Introducer Kit Receives FDA and CE Mark Approvals


July 31, 2018—Integer Holdings Corporation, an outsource manufacturer, announced that it has received United States FDA and European CE Mark approvals for the RadialSeal radial access introducer. Integer's portfolio of access devices is available for distribution by medical device companies in the interventional cardiology and peripheral vascular markets.

According to the company, the RadialSeal introducer kit is founded on Integer's core technology platforms in guidewires and hemostatic introducers. The RadialSeal features a thin-walled sheath design that minimizes outer diameter while maximizing inner diameter and provided ease of sheath insertion through smooth transitions and a hydrophilic coating.


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.