Sansum Clinic Cardiologists Initiate Clinical Trial to Test Bioresorbable Vascular Scaffold for Treatment of Heart Disease

Sansum Clinic to Enroll Patients in ABSORB III Trial Studying "Disappearing" Heart Device

SANTA BARBARA, Calif., Dec. 6, 2013 /PRNewswire-USNewswire/ -- Physicians at Sansum Clinic are currently enrolling patients in the ABSORB III clinical trial.  ABSORB III is the first U.S. clinical trial to evaluate the potential benefits of the Absorb Bioresorbable Vascular Scaffold (BVS) in comparison to a medicated metallic heart stent, also called a drug eluting stent, in patients with coronary artery disease, the most common form of heart disease.

The Absorb BVS, made by global healthcare company Abbott, 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. The scaffold 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.

Sansum Clinic cardiologists, Dr. Joseph Aragon (Principal Investigator) and Dr. Michael Shenoda (Sub-Investigator), are among the first cardiologists in the central coast region enrolling patients into the ABSORB III clinical trial. The trial is being conducted at Santa Barbara Cottage Hospital. 

Coronary artery disease is a leading cause of death for men and women in the United States.  Patients with this disease can experience symptoms such as chest pain and shortness of breath when the demand for blood to the heart is more than the heart's ability to supply blood due to blockages in the vessels. These blockages are caused by the build-up of fat and cholesterol inside the vessel.

Since the 1970s, physicians have treated coronary artery disease patients with balloon angioplasty and metallic and drug eluting metallic stents, allowing many patients to avoid open heart surgery.

Unlike a metallic stent that remains permanently in the body, Absorb is referred to as a scaffold to indicate that it is a temporary structure. This Absorb BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.

The ABSORB III clinical trial will enroll approximately 2,250 patients, the majority in the United States. The primary endpoint of the trial is target lesion failure, a combined measure of safety and efficacy, at one year compared to standard treatment. In addition, a subset of patients 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 their 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 United States.

About Sansum Clinic
Since its founding in 1921, Sansum Clinic has been improving the overall health of our patients by providing the latest innovations in equipment, technology, procedures and treatments.  Sansum Clinic is the largest independent nonprofit healthcare organization between the Los Angeles Basin and the San Francisco Bay Area.  With more than 180 affiliated physicians, the Clinic provides the full spectrum of healthcare services, from primary care to more than 30 specialties.   Sansum Clinic serves more than 150,000 patients (600,000 visits) annually at our 23 patient care facilities in south Santa Barbara County.  Sansum Clinic can be found online at www.sansumclinic.org

About Santa Barbara Cottage Hospital and Cottage Health System
The not-for-profit Cottage Health System includes Santa Barbara Cottage Hospital -- and its associated Cottage Children's Hospital and Cottage Rehabilitation Hospital, Santa Ynez Valley Cottage Hospital, and Goleta Valley Cottage Hospital. Last year, the Cottage hospitals provided inpatient care for 20,000 people, treated 69,000 patients through their 24-hour emergency departments and helped deliver 2,300 babies.

SOURCE Sansum Clinic