LAKE FOREST, Calif.--(BUSINESS WIRE)--NaviGate Cardiac Structures Inc. (“NCSI”), an emerging medical device company developing valved stents for replacement of incompetent mitral heart valves, announced today 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+* MR. The interventional team was led by Dr. Cristián Baeza Prieto at San Borja Arriarán Hospital in Santiago, Chile, on October 26, 2015. The patient is thriving at four weeks post-procedure.
Early post-surgical evaluation showed that the NCSI catheter-guided procedure significantly improved the patient’s heart function by totally eliminating mitral regurgitation. 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 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 Cristián Baeza Prieto, M.D., 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 Dr. Baeza was Dr. Gabriel Maluenda, Interventional Cardiologist at the institution.
“The patient was considered at very high risk for conventional surgery,” said Professor 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.”
“The road to the milestone of a successful First-In-Human implant of the NaviGate valved stent is gratifying but without question demanded intensive care in making the transition from preclinical studies. We at NCSI are very fortunate to have Dr. Jose L. Navia from the Cleveland Clinic, who had the seminal idea, and the team of Prof. Jerzy Sadowski and Dr. Krzysztof Bartuś from St. Jan Paul II hospital department of Cardiovascular Surgery and Transplantology in Krakow, Poland, to work with us on the way to this gigantic step. This First-In-Human result clearly demonstrates great promise that the valve can be implanted via a minimally invasive procedure and immediately eliminate mitral regurgitation upon implantation in a highly compromised patient whose options may otherwise be limited," said Dr. Rodolfo C. Quijano, CEO of NCSI.
Mitral valve disease affects about two to three percent of the world's population and an estimated 2.3 million patients in the U.S. 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 U.S. alone, while over 80% are untreated for this disease. A significant number of patients have limited options for treatment because they are too sick to survive surgery.
NaviGate Cardiac Structures Inc. (www.navigatecsi.com) is an early-stage company focused on developing transcatheter solutions for the less-invasive treatment of atrioventricular valve regurgitation. The NaviGate valved-base technology was licensed from Cleveland Clinic and further modified and developed by NCSI.
NOTE: NCSI’s technology is not approved for investigational use in the United States.
* New York Heart Association (NYHA) Functional Classification Scale for MR—4+: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.