Micro Interventional Devices last week touted early results from a study of its minimally invasive annuloplasty technology as a treatment for severe tricuspid regurgitation.
The technology has been successfully implanted percutaneously in four patients, the company reported.
The procedure uses fluoroscopy and 3D echocardiography to plae the anchors of the implant on the annulus of the tricuspid valve, according to MID. The company’s PolyCor anchoring technology allows for the percutaneous bicuspidization of the tricuspid valve, the company explained, replicating the results of an open surgical bicuspidization procedure.
MID enrolled patients ages 61 to 85 years old who suffered from severe tricuspid regurgitation into the trial. The company reported that the study has thus far produced significant reductions in tricuspid regurgitation of 2 or more grades from severe/torrential to moderate/mild or mild.
“The outcomes of these procedures are really impressive, with significant reductions in tricuspid regurgitation and annular dimensions,” Dr. Joachim Schofer, chief of cardiology at the Albertinan Medical Center, said in prepared remarks. “The MIA technology appears to be easy to deploy and the implant can be customized to the patient’s anatomy.”
The company plans to enroll 40 patients in the trial and expects that the results will support an application for CE Mark clearance. The company also plans to expand the trial to the U.S. next year.
“MID set out to develop a technology that is simple, safe and secure,” president & CEO Michael Whitman said. “That was over 7 years ago. The early outcomes we are experiencing with MIA suggest that we have achieved this objective. Clearly we are extremely pleased with these results and are very thankful for the guidance and support of our talented interventional and surgeon advisors.”
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