Guided Delivery Systems, Inc. Successfully Treats First Patient with Mitral Regurgitation

SANTA CLARA, California -

Guided Delivery Systems, Inc. (”GDS”) announced the first successful percutaneous implantation of the GDS Accucinch(R) System for mitral valve repair. The procedure was performed by Prof. Dr. med. Joachim Schofer of Medizinisches Versorgungszentrum, Hamburg University Cardiovascular Center in Hamburg, Germany. The GDS Accucinch System significantly reduced the patient’s mitral regurgitation without requiring open heart surgery.

Dr. Schofer commented, “While mitral valve repair is a common surgical procedure, it usually requires open heart surgery. The GDS Accucinch System is introduced using catheters placed through the femoral artery. The interventional cardiologist can mimic a surgical mitral valve repair without opening the chest and without the need for heart lung bypass. Using this new technology the patient can be treated in a safe, less invasive way so he or she can quickly resume normal day-to-day activities. In fact, this particular patient was up and walking the day after the procedure, and able to return home to normal activities within a week.”

Mitral valve regurgitation, or leakage, is a significant cardiac problem in approximately six million patients worldwide(1). Leakage is often caused by enlargement of the mitral ring, or annulus, preventing the mitral leaflets from closing effectively. The GDS Accucinch System is an innovative percutaneous device, placed through an artery in the patient’s leg that cinches the subvalvular mitral annulus to reduce its size until the backward flow of blood through the mitral valve is corrected. This device mimics surgical mitral repair by directly modifying the geometry of the mitral apparatus in order to reduce mitral regurgitation. The GDS Accucinch System can also properly size the mitral opening by use of measurements of regurgitation in the beating heart during the procedure which cannot be made when the patient is on a bypass machine.

“Our goal at GDS is to develop a fully percutaneous treatment of the mitral valve and left ventricle to correct functional mitral regurgitation that leverages standard imaging and physician skills,” said inventor of the GDS Accucinch System and CEO of Guided Delivery Systems, Niel Starksen, M.D. “First human use of the percutaneous delivery of the GDS Accucinch System is an important milestone on the pathway to bringing the millions of patients with functional mitral regurgitation a safe and effective treatment using the skills that interventional cardiologists already have and practice every day.”

Dr. Schofer will discuss the GDS Accucinch System and highlights from the case further on September 25, 2009 during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference being held in San Francisco, CA.

Dr. John Webb, St. Paul’s Hospital, University of British Columbia, Vancouver, Canada is Co-Principal Investigator for the clinical trial and is actively screening patients for the study. The number of clinical sites is expanding to include additional sites in both Germany and Canada, and additional studies are being planned in the United States.

About Mitral Valve Regurgitation

Mitral valve regurgitation or MR is a condition in which the mitral valve, one of the valves in the heart, does not close tightly during the cardiac cycle, allowing the blood to flow backward. Since the blood is not moving as efficiently as it should through the heart and the body, MR can result in fatigue and shortness of breath. As many as one in five people over the age of 55 may have some level of MR(2). It has been estimated that more than one in eight people aged greater than 75 years old have at least moderate heart valve disease(3) a population expected to quadruple in the next 50 years(4). Furthermore, many patients with heart failure are found to have moderate to severe MR. MR is, therefore, a common and serious condition that may be addressed by new technologies, like the GDS Accucinch System, in the future.

About Guided Delivery Systems, Inc.

Guided Delivery Systems, Inc. is a privately funded, development-stage company founded in December 2002, based in Santa Clara, California. The company’s mission is to become the industry leader in providing safe, minimally invasive and clinically effective solutions to millions of untreated patients with life impairing and potentially life threatening heart valve conditions. For more information, please contact Peggy Arvizu at +1-408-727-1105 ext. 204.

The GDS Accucinch System is not currently available in the U.S.A. for sale or clinical trials. Clinical evaluation is in process in Europe and Canada.

1. Health Research International, “Opportunities in Heart Valve Disease Management: Europe, Japan and Rest of the World”, pages 93 and 96; and “U.S. Opportunities in Heart Valve Disease Management”, page 74.

2. www.mayoclinic.com/health/mitral-valve-regurgitation/DS00421

3. www.nhlbi.nih.gov/health/dci/Diseases/hvd/hvd_whoisatrisk.html

4. www.mayoclinic.com/health/mitral-valve-regurgitation/DS00421/ DSECTION=symptoms

Source: Guided Delivery Systems, Inc.

Peggy Arvizu of Guided Delivery Systems, Inc., +1-408-727-1105, ext. 204