NaviGate performs 1st-in-human transcath mitral valve replacement

Emerging heart valve-focused company NaviGate Cardiac Structures said it performed the 1st-in-human implant of its catheter-guided, mitral-valved stent.

The company’s transcatheter mitral valve replacement system includes 2 sets of stent wings designed to surround the valve and incorporate leaflets against the valve annulus, which open with stent self-expansion to attach to the mitral valve annulus through radial force.

A 53-year-old male patient with severe 4+ mitral regurgitation received the implant, and the procedure was performed by a team was led by Dr. Cristián Baeza Prieto at Santiago, Chile’s San Borja Arriarán Hospital.

“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,” Dr. Baeza said in prepared remarks.

Post-surgical evaluations showed total elimination of mitral regurgitation, and the company said the patient was “thriving” at 4 weeks.

“The road to the milestone of a successful 1st-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,” CEO Dr. Rodolfo Quijano said in a press release.

The device is designed to restore mitral valve functions in patients with moderate or severe MR who have been deemed inoperable or at high risk of mortality if treated by conventional heart surgery, the company said.

NaviGate’s heart valve technology was licensed from the Cleveland Clinic and further modified and developed by NCSI, and is currently not approved for investigational use inside the U.S.

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