NaviGate Cardiac Structures has revealed that the first-in-human implant of its catheter-guided, mitral-valve stent into a beating heart was performed successfully in a 53-year-old male patient presenting with severe mitral regurgitation. The interventional team was led by Cristián Baeza Prieto (San Borja Arriarán Hospital in Santiago, Chile); the patient is reported to be “thriving” at four weeks post-procedure.
A press release reports that early post-surgical evaluation showed that the catheter-guided procedure significantly improved the patient’s heart function by totally eliminating mitral regurgitation. It adds that the NaviGate innovative technology involves the use of a diffuser-shaped or truncated-cone nitinol stent including a trileaflet pericardial valvular mechanism that restores mitral valve function in patients with moderate or severe mitral regurgitation and who have been determined to be inoperable or at high risk of mortality if treated by conventional heart surgery. The valve tissue is preserved by the usual fixation but includes technology of dehydration licensed from Cleveland Clinic that removes the toxic fixative and allows shipment of the device in dehydrated form.
NCSI chose to initially deliver the valve by a transatrial approach, thus minimising the complications experienced by heart valves presently delivered transapically through a heart tip that is severely damaged by the disease and that must maintain pumping for a lifetime after recovery from the apical puncture.
The implant procedure was performed by Prieto as part of a feasibility study that will be also carried out in Krakow, Poland, and Varese, Italy. He notes: “The patient was considered at very high risk for conventional surgery. The implantation was completed and the valve began functioning well upon completion of the procedure. I was able to make minor adjustments to the valve position and see a mitral valve demonstrating normal function. This will be an excellent addition to our armamentarium in the treatment of these patients, who have at present no viable choice to survive this condition.”