First Patients Enrolled in the Access-Europe Study of The MitraClip(R) Therapy
European Post Market Observational Study Intended to Collect Data to Demonstrate the Clinical and Health Economic Benefits of the MitraClip(R) Therapy for Patients with Mitral Regurgitation
MR affects millions of people worldwide and is the most common type of heart valve insufficiency in
The first patients were enrolled in ACCESS-Europe by a team led by Professor
“ACCESS-Europe will provide important clinical care and health economic information about the MitraClip(R) therapy,” said Professor Tamburino, chair of cardiology, cardiology department, cardiac catheterization and interventional cardiology, Ferrarotto Hospital, University of Catania,
The ACCESS-Europe study will evaluate the MitraClip(R) therapy in the continuum of care available to patients with MR. Patients will be evaluated at baseline through 12 months after enrollment. As many as 20 institutions within
“Initiating enrollment in ACCESS-Europe is another important milestone for Evalve and the MitraClip therapy,” said
Evalve received CE Mark approval for the MitraClip(R) system last year, and has worked with hospitals across
About the MitraClip(R) Procedure
Percutaneous mitral repair with Evalve’s MitraClip(R) device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip(R) device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.
About Evalve, Inc.
Founded in 1999, Evalve, Inc., headquartered in
The MitraClip(R) system is currently undergoing clinical evaluation in
MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.
SOURCE Evalve, Inc.