Mitralign said today it launched the Scout II study of its Trialign system designed for treating patients with tricuspid regurgitation, looking to support eventual CE Mark approval in the European Union.
The Trialign device, which is designed to be delivered by catheter, uses implanted anchors to help restore valves to their natural shape and reduce tricuspid regurgitation, the Tewksbury, Mass.-based company said.
“We are pleased to be the first center in Europe to commence enrolling in Scout II. This is an exciting therapy which allows us to deliver a minimally invasive solution to a group of patients who have limited treatment options. The procedure was a great success, as we saw acute reduction in tricuspid regurgitation and the patient was able to go home shortly thereafter,” Dr. Azeem Latib of Milan, Italy’s San Raffaele Scientific Institute said in a prepared statement.
The company said that its devices have a small footprint to enable more clinical options for future interventions.
“The tricuspid valve is the last major valve opportunity in the structural heart space. The 6-month data from our Scout I EFS Study in the United States has provided early safety and efficacy signals that we plan to build on with Scout II,” CEO Rick Geoffrion said in a press release.
Last May, Mitralign said it raised nearly $40 million in a Series E round to support both its Mitralign annuloplasty system and the Trialign system.