News | September 16, 2009

Guided Delivery Systems Successfully Treats First Patient With Transcatheter Mitral Valve

September 16, 2009 – Guided Delivery Systems Inc. (GDS) announced the first successful percutaneous implantation of the GDS Accucinch System for mitral valve repair.

The procedure was performed by professor Joachim Schofer, M.D., 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.

"While mitral valve repair is a common surgical procedure, it usually requires open heart surgery,” said Schofer. “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 is a significant cardiac problem in approximately 6 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 a 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 Guided Delivery Systems CEO 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."

Schofer will discuss the GDS Accucinch System and highlights from the case further Friday, Sept. 25, during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.

John Webb, St. Paul's Hospital, University of British Columbia, Vancouver, Canada, is coprincipal 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.

The GDS Accucinch System is not currently available in the United States for sale or clinical trials. The 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.

For more information: www.gdsmed.com

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