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for Transcatheter Valve-In-Valve Procedures

First TAVR Device Indicated for Replacement of Failed Surgical Heart Valves Expands Patient Population That Can Benefit from Minimally Invasive Procedure

valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed.

Each year, approximately 200,000 people worldwide receive surgical aortic valvesi, which typically last 15 years or more. When a surgical valve degenerates over time, patients may require another valve replacement. However, some patients are too sick or frail for a second open-heart surgery, and the transcatheter VIV procedure may now provide them with a new treatment option.

During the VIV procedure, the RTM System is placed inside a failing surgical heart valve with an inner diameter from 17-29 mm through a low-profile, 18Fr delivery catheter, which is approved for use with all four RTM sizes (23mm, 26mm, 29mm and 31mm), as well as three delivery approaches (transfemoral, subclavian and direct aortic).

The RTM System was approved by the FDA in 2014 for patients at extreme risk and high risk for surgery, and received CE (Conformité Européenne) Mark for VIV procedures in May 2013.


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