FDA Grants IDE Approval to Mitralign to Conduct Study of PTVAS System

The FDA has granted Investigational Device Exemption approval to Tewksbury, Mass.-based Mitralign Inc. to conduct an early feasibility study to examine its percutaneous tricuspid valve annuloplasty system.

The system is designed to be a minimally invasive option to treat tricuspid regurgitation occurring when the tricuspid valve fails to open and close properly, causing blood to flow backward into the right atrium.

CEO Rick Geoffrion says the device mimics a known surgical procedure, but does not require open heart surgery. The system provides a potential treatment option for patients who are too sick for surgical intervention.

The study will take place in select centers in the U.S. The system is not available for sale or distribution. — Michael Cipriano