Minimally Invasive Investigational Procedure Treats Mitral Regurgitation as an Alternative to Open Heart Surgery

First Pennsylvania enrollment in the ACTIVE clinical study with Edwards Cardioband™ Mitral Reconstruction System performed at UPMC Pinnacle

HARRISBURG, PA, April 25, 2018 (GLOBE NEWSWIRE) -- The ACTIVE trial studies Edwards Cardioband Mitral Reconstruction System, a catheter-based annular reduction device for treatment of functional mitral regurgitation (FMR) patients who are poor candidates for surgical annuloplasty, which traditionally requires the chest to be cracked. The Cardioband implant treats the leaky mitral valve by placing a partial ring around the mitral valve annulus through a small, minimally invasive, incision in the leg while the heart remains beating.

 

Mitral regurgitation (MR) is a condition in which the mitral valve leaflets fail to close properly, allowing backflow of blood from the left ventricle into the left atrium during systole. Left untreated, severe MR can eventually lead to a meaningful deterioration in cardiac function and, eventually, death. Approximately 4.2 million patients in the U.S. alone are affected by mitral valve disease.

 
UPMC Pinnacle is one of 50 sites in the United States, Canada and Europe and the first site in Pennsylvania selected to participate in the ACTIVE trial. Approximately 375 patients will be enrolled into the randomized ACTIVE trial, which is sponsored by Edwards Lifesciences.

 

During traditional mitral valve surgery surgeons often go through the sternum, putting the heart on bypass to place an annuloplasty ring with sutures around the mitral valve. With the Cardioband Mitral System, doctors can use the device to repair the mitral valve via a minimally invasive transcatheter, off-pump procedure. Placement is confirmed real-time with specialized imaging (echocardiogram).

 

This new trial at UPMC Pinnacle is led by Mubashir Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery and surgical director of structural heart, and Hemal Gada, MD, MBA, medical director of structural heart and interventional cardiologist.

 

“This investigational device, the Edwards Cardioband Mitral Reconstruction System, represents the next wave of minimally invasive mitral valve therapies,” states Dr. Mumtaz. “If proven effective, we are hopeful it will mirror the success we have experienced with minimally invasive procedures for aortic valve treatment.”

 

“UPMC Pinnacle continues to be on the forefront of leading edge technology, allowing our patients to have early access to therapies while they are in development,” says Dr. Gada.

 

In early stage clinical trials, the Edwards Cardioband Mitral Reconstruction System was shown to be safe and effective at reducing mitral regurgitation (MR) and decreasing heart failure symptoms. The device is commercially available in Europe. 

RESOURCES:
Link to Cardioband Mitral System Animation provided by Edwards Lifesciences
Image attached - Cardioband Mitral Reconstruction System provided by Edwards Lifesciences

 

About UPMC Pinnacle

UPMC Pinnacle is a nationally recognized leader in providing high-quality, patient-centered health care services in central Pennsylvania and surrounding rural communities. Its medical staff of more than 2,900 physicians and allied health professionals and approximately 11,000 employees serve a 10-county area at outpatient facilities and eight acute care hospitals with 1,360 licensed beds: Carlisle, Community Osteopathic, Hanover, Harrisburg, Lancaster, Lititz, Memorial, and West Shore. The not-for-profit system anticipates caring for more than 1.2 million area residents in FY 2018. For more information, visit www.UPMCPinnacle.com.

Attachment

• Cardioband Mitral System annuloplasty ring

Kelly McCall
                    UPMC Pinnacle
                    717-231-8104
                    kmccall@pinnaclehealth.org