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Washington Hospital Cardiologist Begins Bay Area's First Bioresorbable Stent Trial

Fremont, Calif., May 23, 2013- Today, Dr. Ash Jain, a cardiologist who has been on the medical staff of Washington Hospital for 20 years, began a clinical trial of Absorb™, the world’s first drug eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease (CAD), which is the narrowing of one or more arteries that supply blood to the heart. Like the more traditional metallic stents, this first-of-its-kind device restores blood flow to the heart. However, unlike its predecessors, the ABSORB stent naturally dissolves into the body and allows natural vessel function to return.

Dr. Jain will perform procedures in the Absorb Randomized Controlled Trial (RCT) Lead-In Phase for Abbott Vascular, which will involve up to 35 sites and 50 subjects. The outcomes from this trial will contribute to the evaluation of the potential advantages of a successful BVS, including:

  • Eliminating stimulus for vessel inflammation and irritation
  • Avoiding challenges and complications with leaving a metal implant behind
  • Enabling vascular remodeling and tissue adaptation
  • Restoring normal vasomotor function of the stented segment

“Heart disease is the number one killer of men and women, and the BVS could revolutionize treatment and advance the options for patient care,” said Ash Jain, MD, cardiologist, Medical Director of the Stroke Program, Medical Director of Invasive Vascular Imaging, Medical CoDirector of Cardiac Care Service, Medical Co-Director of Vascular Services Program. “Clinical trials are one of the greatest ways to stay on top of best practices, and I am committed to pursuing treatments that could benefit patients in this community.”

The outcomes from the lead-in phase will determine whether the physician training requires further modification to meet the needs of US physicians.

Following the lead-in phase, Washington Hospital will also participate in three RCT cohorts, known as Absorb III, Absorb Imaging, and Absorb IV. The pivotal trial will support the US pre-market approval of Absorb BVS System and evaluate the safety and effectiveness of the System compared to the commercially approved, control stent XIENCE. As in all clinical trials, the participating patients in the clinical trial will go through an extensive consent process.

“I am proud of Washington Hospital’s role in advancing the field of medical discovery and improving outcomes for our patients,” said Nancy Farber, CEO. “Dr. Jain is a true leader in his field and that leadership is improving our patient’s outcomes.”

About the Absorb Bioresorbable Vascular Scaffold

The Absorb bioresorbable vascular scaffold, similar to a small mesh tube, is designed to open a blocked heart vessel and restore blood flow to the heart. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a stent, which is a permanent implant. The scaffold provides support to the vessel until the artery can stay open on its own, and then dissolves naturally. Absorb leaves patients with a vessel free of a permanent metallic stent and may allow the vessel to resume more natural function and movement, enabling long-term benefits. Abbott's BVS delivers everolimus, an anti-proliferative drug used in Abbott's XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

Absorb is neither approved nor authorized for sale and currently is in development with no regulatory status in the United States. Absorb is authorized for sale in CE Mark countries. Absorb is now available in Europe, the Middle East, parts of Asia Pacific, including Hong Kong, Singapore, Malaysia and New Zealand, and parts of Latin America.

About Washington Township Health Care District

Washington Township Health Care District is governed by an elected board of directors. Unlike a municipal or county hospital, WashingtonHospital’s operating expenses, research, community programs, and employee salaries are funded by revenues generated through providing patient and other health care services. Washington Hospital Healthcare System includes a 389-bed acute-care hospital; the Taylor McAdam Bell Neuroscience Institute; The Gamma Knife® Center; Washington Radiation Oncology Center; Washington Outpatient Surgery Center; Washington Outpatient Rehabilitation Center; Washington Outpatient Catheterization Laboratory; Washington Institute for Joint Restoration and Research; the Institute for Minimally Invasive and Robotic Surgery; and Washington West, a complex which houses Washington Women’s Center, Outpatient Imaging Center, Sandy Amos R.N. Infusion Center, Washington Urgent Care and additional outpatient hospital services and administrative facilities.