NaviGate Cardiac Structures Reports Successful FIH Implantation of Mitral-Valved Stent

November 23, 2015—NaviGate Cardiac Structures Inc. (NCSI) announced the successful first-in-human (FIH) implantation of the company’s catheter-guided, mitral-valved stent. The company reported that the patient, a 53-year-old man with severe 4+ mitral regurgitation (MR), was treated on October 26 and is thriving at 4-weeks postprocedure.

An interventional team led by Cristián Baeza Prieto, MD, Professor of Cardiac Surgery, performed the procedure at San Borja Arriarán Hospital in Santiago, Chile. The procedure is part of a feasibility study that will be also conducted in Krakow, Poland, and Varese, Italy.

According to the company, the early postprocedure evaluation showed that treatment with the NCSI device significantly improved the patient’s heart function by totally eliminating MR.

The NaviGate technology uses a diffuser-shaped or truncated-cone nitinol stent with a trileaflet pericardial valvular mechanism that restores mitral valve function in patients with moderate or severe MR who have been determined to be inoperable or at high risk of mortality if treated surgically. The valve tissue is preserved by the usual fixation but includes dehydration technology licensed from Cleveland Clinic that removes the toxic fixative and allows shipment of the device in a 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.

In NCSI’s press release, Prof. Baeza commented, “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.”

The company noted that the device was invented based on an idea by Jose L. Navia, MD, of the Cleveland Clinic in Cleveland, Ohio, and was further modified and developed by NCSI with Prof. Jerzy Sadowski, MD, and Krzysztof Bartus, MD, from the Department of Cardiovascular Surgery and Transplantology at St. Jan Paul II Hospital in Krakow, Poland.

The NaviGate valved-base technology is licensed from the Cleveland Clinic. NCSI advised that the device is not approved for investigational use in the United States.