Device previously studied in three-year clinical trial at PinnacleHealth
HARRISBURG, Pa. (July 14, 2016) – The same PinnacleHealth team that participated in a three-year clinical trial designed to evaluate potential benefits of a first-of-its-kind drug eluting ABSORB Bioresorbable Vascular Scaffold (BVS), today announced it deployed the device for the first time after FDA approval for commercial use. The recipient was the first in Pennsylvania to receive the device post-trial and the first patient in the in the United States treated with a BVS for heart attack.
ABSORB is referred to as a scaffold to indicate its temporary nature, unlike a permanent metallic stent. ABSORB works by restoring blood flow to the heart, keeping the vessel open until it can stay open on its own and then dissolving completely over time. The trial showed that ABSORB performed as well as a drug-coated metallic stent.
Coronary artery disease is commonly treated with metal stents, which are tiny mesh tubes that prop open clogged heart arteries. In contrast, the new stent is made of a material, called polylactide, similar to dissolving medical stitches that slowly disappears in about two years. Patients benefit because ABSORB treats the vessel and dissolves, allowing the artery to resume more natural function and movement because it is free of a metallic implant.
“As a physician, it is invigorating to be a part of clinical research that positively impacts our patients in central Pennsylvania,” said William Bachinsky, MD, FACC, FSCAI director of cardiovascular research and the cardiac catheterization labs at PinnacleHealth. “By participating in clinical trials at PinnacleHealth, we bring cutting-edge technology to the region years before FDA approval for commercial use.”
PinnacleHealth CardioVascular Institute is currently one of 10 sites in the United States with the ABSORB BVS.
EDITOR’S NOTE: Attached is a patient testimonial related to the ABSORB III clinical trial. The patient in this story, Ron Ross, is willing to speak to the media. It was a blinded study, meaning that Mr. Ross does not know if he received the BVS or another stent.
About PinnacleHealth System
PinnacleHealth System has been a leading provider of inpatient and outpatient healthcare services in central Pennsylvania since 1873. The 636-bed system has three acute care hospitals (Community General Osteopathic, Harrisburg and West Shore Hospitals) on four campuses (Community, Harrisburg, Polyclinic and West Shore) serving a five-county service area and supporting rural hospitals through affiliations and telehealth services. PinnacleHealth pursues innovative treatment options for the region through cardiac and cancer clinical trials, while offering convenient community services including medical home-certified primary care, urgent care, Magnet-recognized nursing excellence, emergency services, imaging, high-volume maternity care and a level III NICU, and workplace-based wellness services. PinnacleHealth includes a CardioVascular Institute and Cancer Institute, as well as a Bone and Joint Institute, Neurosurgery and Neurosciences Institute, and Spine Care Center that combine a multi-disciplinary approach to comprehensive spine, bone, joint, orthopedic and sports medicine services. PinnacleHealth is recognized for high-quality care with national and regional recognitions for volumes, outcomes and safety. For more information, visit pinnaclehealth.org.