120
Participants
Start Date
November 24, 2022
Primary Completion Date
November 24, 2025
Study Completion Date
November 24, 2029
GeminiOne Transcatheter Valve Edge-to-Edge Repair System
The transcatheter valve clamp system consists of a valve clamp, an adjustable bend mid-tube, and a manipulated inner tube. The adjustable bend introducer catheter consists of an adjustable bend outer tube and dilator. The valve clip is composed of nickel-titanium alloy, cobalt-chromium-nickel-molybdenum-iron alloy, and polyethylene terephthalate material and contains a closure clip, gripping tab, central mechanism, braid, and suture. The adjustable bend guiding catheter is used to provide access to the transcatheter valve clamping system and to reach the designated position. The adjustable curved mid-tube and manipulated inner tube are used to enable the delivery, gripping, and release process of the valve clips within the body.
RECRUITING
Peiga Medical Technology (Suzhou) Co., Suzhou
Peijia Medical Technology (Suzhou) Co., Ltd.
INDUSTRY