Princeton Baptist Medical Center is a study site for the ABSORB III trial studying “disappearing” heart device
Contact: Jennifer Dodd
Phone: (205) 783-3526
BIRMINGHAM, September 9 2013 — Cardiology, P.C. is enrolling participants in the ABSORB III clinical research trial at Princeton BMC, testing the Absorb Bioresorbable Vascular Scaffold (BVS) in comparison to a medicated metallic heart stent. The Absorb BVS is manufactured by the healthcare company, Abbott. Dr. Alain Bouchard, Cardiology P.C.’s Principal Investigator for the study, enrolled the first participant locally this summer.
The Absorb BVS is a small mesh tube that is designed to open a blocked heart vessel, restore blood flow to the heart, and then dissolve into the blood vessel over time. Unlike a metallic stent that remains permanently in the body, the Absorb BVS is referred to as a scaffold to indicate that it is a temporary structure. The Absorb Stent is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
ABSORB III is the first U.S. clinical research trial to evaluate the potential benefits of the scaffold in comparison to a medicated metallic heart stent, also called a drug eluting stent, in participants with a form of heart disease known as coronary artery disease (CAD). Princeton BMC is one of the first hospitals in the state to be a study site for the ABSORB III research trial.
“It’s very exciting to be a part of this trial,” said Dr. Bouchard, “and we’re very fortunate that Princeton Baptist is one of the few hospitals in Alabama where this research will take place. With this trial, we’re paving the way for evaluating new options to treat coronary disease.”
Since the 1970s, physicians have treated patients with CAD with balloon angioplasty, metallic and drug eluting metallic stents, allowing many patients to avoid open-heart surgery. About a decade ago, scientists at Abbott started development of the Absorb BVS and now Abbott is the first company in the world to begin testing a bioresorbable vascular scaffold in partipants in the United States.
Dr. Bouchard and his partners at Cardiology PC are very familiar with clinical trials and the invaluable benefits this type of research can provide participants. “We’ve been doing clinical research for over 20 years, so we have a track record with trials. Over the years, we’ve seen an improvement in stent design from metal stents to medication coated stents, also known as drug eluting stents, which have led to improvement in outcomes. And now the fully bioresorbable scaffold – it’s exciting for the field and for our participants to see the evolution of stent technology.”
It is expected that approximately 2,250 participants will be enrolled in the ABSORB III clinical research trial. Most of these will be in the United States. The primary endpoint of the trial is target lesion failure, a combined measure of safety and efficacy, at the one year anniversary date of the procedure. In addition, a subset of participants within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.
Each year, about 785,000 Americans have a first heart attack. Another 470,000 who have already experienced one or more heart attacks will have another. Heart disease accounts for one of every six deaths that take place in the U.S.2
Cardiology, P.C. is continuing to enroll participants in the ABSORB III trial. While participants must meet a strict set of requirements, Cardiology P.C. is currently conducting evaluations at Princeton BMC to determine if interested persons meet the qualifications. To learn more about enrollment in this research, please contact Wesley Wade at (205) 949-5234.
About Princeton Baptist Medical Center - Opened in 1922, Princeton Baptist is the flagship hospital of Baptist Health System. Today, Princeton Baptist is a full service tertiary hospital with approximately 1,500 employees providing a wide range of services including such specialties as diagnostic imaging, cancer treatment, wound care, cardiac services and surgery, pulmonary medicine, neurosurgery, obstetrics and orthopedics.
1Absorb dissolves except for two pairs of tiny metallic markers, which help guide placement and remain in the artery to enable a physician to see where the device was placed.
2 Signs and Symptoms, Centers for Disease Control and Prevention. April 9, 2012. http://www.cdc.gov/heartdisease/signs_symptoms.htm
CAUTION: Investigational device limited by Federal (U.S.) law to investigational use only.
Absorb is a trademark of the Abbott Group of Companies.