Abbott (NYSE:ABT) said today it enrolled the 1st patient in a clinical trial of a minimally invasive, clip-based transcatheter valve repair system for treating patients with severe tricuspid regurgitation, looking to eventually support CE Mark approval in the European Union.
The 1st patient in the trial was enrolled at the Abbott Northwestern Hospital by Dr. Paul Sorajja of the Minneapolis Heart Institute, the Abbot Park, Ill.-based company said.
The transcatheter tricuspid valve repair system is built off of technology which has been tested with the company’s MitraClip system, designed to treat mitral valve regurgitation, Abbott said.
“Current pharmacological and surgical treatment options are not meeting the needs of people living with tricuspid regurgitation. Abbott’s MitraClip has shown positive results for mitral regurgitation, and we hope this study shows that a similar clip-based technology may effectively treat people with tricuspid regurgitation,” trial lead investigator Dr. Georg Nickenig of Bonn, Germany’s University Hospital said in a press release.
The newly launched Triluminate study will look to enroll 75 symptomatic patients at 25 US and European sites. Primary endpoints will include echocardiographic tricuspid regurgitation reduction of greater than or equal to 1 grade at 30 days post-procedure and the assessment of major adverse events at 6 months.
“As a leader in structural heart therapies, Abbott is exploring new ways to treat people with heart valve diseases. The investigational medical device that will be used in this study builds on years of learnings and knowledge using our clip-based device for treating mitral regurgitation. We look forward to the results of the trial to determine if this new minimally invasive technology has the potential to benefit people living with tricuspid regurgitation just as predictably,” chief medical officer Dr. Charles Simonton said in a prepared statement.
Abbott said it is hopeful that the trial will support its application for CE Mark approval in the EU for the clip-based tricuspid valve repair system.
In May, a Canadian cardiologist said they had successfully inserted and performed a procedure with Abbott’s MitraClip through the jugular vein instead of the femoral vein.