November 23, 2015 — NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved stent into a beating heart was performed successfully in a 53-year-old male patient presenting with severe 4+ mitral regurgitation (MR). The interventional team was led by Cristián Baeza Prieto, M.D., at San Borja Arriarán Hospital in Santiago, Chile, on Oct. 26, 2015. The patient is thriving at four weeks post-procedure.
Early post-surgical evaluation showed the NCSI catheter-guided procedure significantly improved the patient’s heart function by totally eliminating mitral regurgitation. The NaviGate technology involves the use of a diffuser-shaped or truncated-cone nitinol stent including a tri-leaflet pericardial valvular mechanism that restores mitral valve function in patients with moderate or severe MR 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 minimizing 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, who is professor of cardiac surgery at San Borja Arriarán Hospital, as part of a feasibility study that will be also carried out in Krakow, Poland, and Varese, Italy. Assisting Baeza was Gabriel Maluenda, M.D., interventional cardiologist at the institution.
“The patient was considered at very high risk for conventional surgery,” said Baeza. “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.”
Mitral valve disease affects about 2-3 percent of the world's population; an estimated 2.3 million patients in the United States and similar number in Europe suffer from moderate to severe mitral regurgitation. Approximately 500,000 new patients present every year with moderate to severe MR in the United States alone, while over 80 percent are untreated for this disease. A significant number of patients have limited options for treatment because they are too sick to survive surgery.
For more information: www.navigatecsi.com
April 17, 2024 
