Marc Gerdisch

FDA Trial for New Tricuspid Valve Technology

Introduction Dr. Marc Gerdisch is a senior partner with Cardiac Surgery Associates and

chief of cardiovascular and thoracic surgery at Franciscan Health in Indianapolis, Indiana. In March 2016, Dr. Marc Gerdisch became the first surgeon to implant the CorMatrix ECM Tricuspid Valve in a patient. The operation was conducted as part of a feasibility study for the device in an attempt to prove its safety. An investigative device exemption from the FDA permitted the first procedure, which was successful.

The artificial valve being tested is a flexible, unstented valve that is able to function as a heart valve immediately after implantation. It is particularly remarkable for its bioscaffolding properties. It acts as a scaffold for the patient's own tissue, and is slowly replaced by new tissue growth over time. This means that the device eventually becomes completely replaced by the patient's natural tissue, leaving no foreign body behind and ending the need for long-term anticoagulation therapies. 

Several other patients have undergone this procedure since the initial success, and up to fifteen will be included in the study as it progresses. CorMatrix is currently recruiting additional participants for the FDA study.