Coherex achieves two milestones in structural heart disease field

In honor of World Stroke Day (October 29, 2010), Coherex Medical, Inc. today announced it has achieved two milestones that further strengthen its position as an emerging medical device company in the field of structural heart disease.

“From what I saw in the procedure performed by Dr. Ruygrok, I am quite certain that the Coherex WaveCrest LAA Occluder System will meet its design objectives to improve safety for patients.”

Specifically, Coherex Medical™

1. Expanded its product portfolio with the unveiling of its Coherex WaveCrest™ LAA Occluder System, a new medical device designed to safely and easily close the Left Atrial Appendage (LAA), a small pouch-like structure found in every human heart and known as a potential breeding ground for blood clots believed to cause 15 percent of all strokes, and
2. Had its Coherex WaveCrest LAA Occluder System successfully used for the first time in a human; the procedure was performed at Auckland City Hospital in New Zealand by one of the world's leading cardiologists, Peter Ruygrok, M.D.

"The Coherex WaveCrest system is a significant advance in LAA occlusion technology," Dr. Ruygrok said. "It offers several major advantages over early LAA devices. It enabled us to optimize the placement of the implant and to seal off the LAA, while minimizing the risk of complications during and after the procedure. The first implantation of this device was extremely successful. WaveCrest presents a valuable new treatment option for patients who suffer from atrial fibrillation and the associated risks of stroke, and possibly enables patients to discontinue difficult-to-manage blood thinners such as Coumadin (Warfarin). This particular patient was at high risk for recurrent stroke, and the structure of the LAA was quite complicated. Nevertheless, the Coherex WaveCrest performed beautifully, and our patient is doing quite well."

Dr. Ruygrok is an interventional cardiologist and a recognized leader in the treatment of structural heart disease. He serves as the Consultant Cardiologist and Clinical Director of the Green Lane Cardiovascular Service at Auckland City Hospital in Auckland, New Zealand, one of the leading heart treatment centers in the world.

"My initial impression? The Coherex WaveCrest is a very impressive solution," Dr. Ruygrok said. "Its intuitive design was easy to use and provided me with great control during placement of the WaveCrest device, allowing us to achieve an excellent outcome. We look forward to treating more patients."

With the unveiling of the Coherex WaveCrest LAA Occluder System and its successful "first-in-man" use, Coherex Medical is formally launching a multi-center study (WAVECREST 1), to be performed in New Zealand, Australia and several European countries. The data from the study are intended to earn the CE Mark for the Coherex WaveCrest LAA Occluder System. In addition to this study, Coherex Medical is currently in discussions with the United States Food & Drug Administration (FDA) regarding the design of a pivotal trial that may lead to product clearance in the U.S. for the Coherex WaveCrest. The company expects to begin this trial sometime near late 2011.

"We are honored to work with Dr. Ruygrok and Auckland City Hospital on this project, and we're very pleased with the successful procedural outcomes," said Richard J. Linder, President and CEO of Coherex Medical. "The excellent results of this procedure represent many years of intensive product development and testing. We are very excited about the potential of our LAA closure program, as the Coherex WaveCrest performed to our highest expectations in this first case in man."

The Left Atrial Appendage (LAA), Atrial Fibrillation (AF) and Stroke Connection

The left atrial appendage (LAA) is a muscular pouch connected to the left atrium of the heart. During normal contractions (typically 60 to 80 beats per minute), the LAA serves as an additional reservoir for blood inside the heart. Unfortunately, during atrial fibrillation (AF or A-Fib), the atria lose their ability to rhythmically contract, and normal atrial contractions do not occur. As a result, blood pools in the LAA and individuals with AF are at greater risk for forming blood clots that travel to the brain and cause a stroke.

According to the American Heart Association, approximately 15 percent of all strokes occur in people with AF. On a worldwide basis, this translates into a potential at-risk population of close to 7 million people. Typically, patients with AF are treated with blood thinners, such as Warfarin (Coumadin), in order to prevent the formation of blood clots. However, Warfarin is a very difficult drug for patients to take and typically requires major changes in lifestyle and constant vigilance of diet and activities.

"Primarily known as a blood thinner, Warfarin is one of the most challenging medications to manage," said Randall Jones, M.D., Chief Medical Officer of Coherex. "Warfarin side effects are frequent, often severe and include significant bleeding complications. As a result, many people are unable to take Warfarin. Studies estimate that up to 50 percent of patients at risk for AF-related stroke may be contraindicated to (unable to use) Warfarin."

According to Dr. Whisenant (who also serves as Director of the Structural Heart Program for Intermountain Medical Center), the Coherex WaveCrest marks a new step forward in LAA closure solutions. "Our experience with the first generation devices demonstrated that LAA closure can benefit A-Fib patients at risk for stroke by enabling them to discontinue Warfarin while reducing the risk of stroke," he said. "From what I saw in the procedure performed by Dr. Ruygrok, I am quite certain that the Coherex WaveCrest LAA Occluder System will meet its design objectives to improve safety for patients."