Global APOLLO Trial Now Underway at UPMC Pinnacle with the Intrepid™ TMVR System for Patients with Severe Mitral Regurgitation



UPMC Pinnacle today announced it is the first in Pennsylvania to treat a patient in the APOLLO Trial – the pivotal trial designed to evaluate the Intrepid™ TMVR system in patients with severe, symptomatic mitral valve regurgitation. As the first-ever pivotal trial for transcatheter mitral valve replacement (TMVR) therapy, the study will evaluate the safety and efficacy of the Intrepid TMVR system in up to 1,200 patients globally. 

The first patient was treated at UPMC Pinnacle Harrisburg by the team of 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.

“UPMC Pinnacle has been a leader in transcatheter valve therapy research, and we are honored to play an instrumental role in exploring this type of less invasive treatment for mitral valve disease through the APOLLO trial,” said Dr. Mumtaz.

Mitral regurgitation occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts. If left untreated, mitral regurgitation can lead to heart failure or death. Due to the complexity of the mitral valve anatomic structure and multiple comorbidities typically present in such patients, limited treatment options are available to clinicians and their patients.

The Intrepid TMVR system integrates self-expanding, dual-stent technology with a replacement tissue heart valve to facilitate a catheter-based implantation. The Intrepid valve is compressed inside a hollow delivery catheter and is inserted between the ribs to enter the heart. The new replacement valve is expanded directly into the malfunctioning mitral valve. The outer stent frame is designed to attach and conform to the native valve without the need for additional sutures, tethers, or anchors to secure the prosthesis. The inner stent houses the valve, which is made from bovine tissue and is intended to maintain blood flow. 

“Intrepid™ TMVR is the latest addition to the cadre of transcatheter valve trials available at UPMC Pinnacle,” said Dr. Gada. “These investigational devices give us innovative options in how we treat valvular heart disease, and we are privileged to add APOLLO to our offerings at UPMC Pinnacle.” 

The APOLLO Trial design consists of two cohorts and will be conducted at up to 60 sites to evaluate two distinct patient populations. The primary endpoint in both cohorts of the trial is a composite endpoint rate of all-cause mortality, all-stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year with secondary endpoints that measure quality of life and valve performance in patients with severe symptomatic mitral regurgitation. 

The Intrepid TMVR system is available for investigational use only and it is not approved for use outside of clinical studies. 

About UPMC Pinnacle

UPMC Pinnacle is a nationally recognized leader in providing high-quality, patient-centered healthcare services in central Pennsylvania and surrounding rural communities. Its 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.




A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/24d33d64-4e52-4990-a7c6-327de22184ce

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/add9787c-0970-4a72-96e7-bc52e059dcce

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/8bde6b35-0bca-4ea0-9405-9deed74a458a

UPMC Pinnacle Cardiac Team - APOLLO Trial with the Intrepid™ TMVR System for Patients with Severe Mitral Regurgitation Intrepid™ TMVR System