Mitralign Reports First-In-Man Percutaneous Tricuspid Repair

September 29, 2014­—Mitralign Inc. reported on the successful use of its technology to perform a percutaneous repair on a patient with tricuspid regurgitation (TR). The procedure was a percutaneous bicuspidization of the tricuspid valve, successfully converting a regurgitating trileaflet valve into a functioning bileaflet valve. Prof. J. Schofer, MD, and Rebecca Hahn, MD, presented details of the procedure at the PCR London Valves Conference held September 28–30, in the United Kingdom.

Prof. Schofer is from the Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease at Albertinen Heart Center in Hamburg, Germany. Dr. Hahn is Director of Interventional Echocardiography at Columbia University Medical Center/New York Medical Center/New York Presbyterian Hospital in New York, New York.

The company advised that the Mitralign device is being evaluated in clinical trials for an indication for use in functional mitral regurgitation. The device is not approved for sale or distribution. The German regulatory body, the Federal Institute for Drugs and Medical Devices, approved the patient for a compassionate use exemption because no other options were available, noted the company. The procedure was performed at the Albertinen Heart Center.

In Mitralign’s press release, Prof. Schofer commented, “We continue to see more and more patients presenting with tricuspid regurgitation and to date, we have not had an interventional device available to treat these patients. This is perhaps the most important intervention I have ever performed. It is the very first percutaneous tricuspid annuloplasty and it was performed successfully; dramatically reducing tricuspid regurgitation with a single small implant and improving the outcome for a patient who would have had a 30% chance of mortality with surgery. I expect that in the future, this will become an outpatient procedure as we start to treat more and more patients in this manner.”

Dr. Hahn added, “Current two-dimensional and three-dimensional echo imaging technologies allow us to easily and accurately place the implant in the correct location, and then immediately see dimensional changes in the valve once the procedure is completed.”

The company stated that treatment with the Mitralign device can eliminate the need to choose one valve over the other and to mimic a Kay bicuspidization surgical repair procedure that has good long-term data. This will enable a physician to successfully treat the tricuspid valve without open surgery.

A company spokesman explained to Cardiac Interventions Today that the primary indication for the Mitralign device is for the treatment of patients with functional mitral regurgitation and a mitral annuloplasty is performed. To support CE Mark approval of the functional mitral regurgitation indication, Mitralign completed a trial (n = 61), with 6-month primary endpoint data to be presented at EuroPCR 2015, which will take place May 19–22, 2015, at the Palais des Congrès in Paris, France. CE Mark approval is anticipated in 2015. The company is not conducting trials in the United States, advised the spokesman.

The Mitralign tricuspid procedure that is being performed in compassionate-use cases is a modified version of its mitral approach. To date, the company does not have a clinical trial for the tricuspid procedure and will continue to evaluate the device through the compassionate-use access.