Mitralign has announced the successful compassionate use treatment of a patient suffering from tricuspid regurgitation due to a cardiac implantable electronic device lead, with their investigational Trialign system. The Trialign system is an investigational device and is limited by US law to investigational use only, and it is designed to offer versatility as a frontline solution to address patients with tricuspid regurgitation.
The SCOUT I early feasibility study using the Trialign system is currently enrolling patients in the USA. The aforementioned patient was treated under the FDA compassionate use exemption. Christopher Meduri (Marcus Heart Valve Center, Piedmont Healthcare, Atlanta, USA) says: “We are pleased to be the first centre in the world to report treatment of a patient with mechanically induced TR due to their pacemaker lead. We continually receive referrals for patients looking for treatment of their tricuspid regurgitation, and a substantial proportion of these patients have leads. This large population of patients has a significant unmet need that could potentially be addressed with a less invasive intervention like this.”
“We believe this is the first reported patient ever treated with a transcatheter device to relieve tricuspid regurgitation that was primarily caused by a lead. Data suggest that one third of patients with severe tricuspid regurgitation have one or more leads in their tricuspid valve, which could be more than 1 million patients worldwide. Any transcatheter solution that is intended to treat tricuspid regurgitation, must address this large population,” comments Rick Geoffrion (chief executive officer of Mitralign).