The University of Virginia press release reminded us about a cool percutaneous device, covered previously, which is still in the clinical trials stage: Evalve MitraClip™.
Here’s company’s info:
The system consists of three major components:
— A steerable guide catheter,
— A steerable clip delivery catheter, and
— The MitraClipTM (an implantable Clip).
The Steerable Guide Catheter is inserted into the femoral vein at the groin and provides a conduit to access the mitral valve. The MitraClip is used to grasp and coapt the leaflets of the mitral valve. The Clip Delivery System delivers and deploys the MitraClip. The principal benefit of the system is that it enables the clinician to repair the mitral valve while the heart is beating, without cardiopulmonary bypass (CPB) and without the need for a thoracotomy or sternotomy.
If necessary, a second MitraClip may be placed — similar to what is done in the surgical E2E repair when a longer suture line is used to increase valve coaptation. In addition, the system is designed to enable the physician to fully reverse all steps prior to implantation of the MitraClip. Specifically, if the physician is not satisfied with initial clip placement (after the mitral valve leaflets have been grasped and approximated), the system is designed to allow for repositioning or removal of the MitraClip. This safety feature is intended to preserve the patient’s conventional surgical options and outlook.
The design of the system includes many additional safety features intended to minimize potential risks, including:
– The MitraClip is designed to capture and retain each leaflet independently, which is intended to minimize the likelihood of clip embolization;
– The MitraClip is covered with a commonly-used implant-grade polyester fabric intended to promote healing that may further help anchor the clip to the leaflets;
– The MitraClip is designed to withstand the expected forces exerted on it during the cardiac cycle and the device is constructed from well-characterized, biocompatible materials that have undergone extensive testing; and
– The MitraClip requires three distinct steps to deploy and release it from the delivery catheter to minimize the potential for pre-mature deployment.