Atrionix Announces the Issuance of Patent for Treating Atrial Fibrillation Via Pulmonary Vein Isolation.

Business Editors/Health and Medical Writers

PALO ALTO, Calif.--(BW HealthWire)--Jan. 17, 2000

Atrionix, Inc., announces the Jan. 11 issuance of a fundamental patent related to catheter-based procedures for curing atrial fibrillation (AF) through circumferential pulmonary vein isolation.

The U.S. Patent and Trademark Office has issued U.S. Patent Number 6,012,457 entitled "Device and Method For Forming a Circumferential Conduction Block In A Pulmonary Vein," originally filed in early 1997. The inventor of this patent is Dr. Michael Lesh, associate professor of Medicine and director of the Atrial Arrhythmia Center at the University of California San Francisco and the company's chief scientific officer. The '457 patent is under exclusive license to Atrionix from the University of California.

AF affects five million people in the developed world, with more than 400,000 new cases diagnosed annually, and is particularly hard on the elderly. There are estimated to be over two million patients in the U.S. currently diagnosed with AF. This arrhythmia often causes palpitations, weakness, fatigue, chest pain, and shortness of breath, and significantly reduces a person's quality of life.

Additionally, atrial fibrillation is a major cause of stroke and people with atrial fibrillation are believed to have as much as five-times the risk of stroke. Drug therapy for AF has been particularly disappointing and surgery is not appropriate for the majority of patients.

"It is our understanding that much, if not all AF is initiated by an abnormal trigger that sets off the arrhythmia," said Dr. Lesh. What has astonished researchers is that the vast majority of these abnormal triggers come from the pulmonary veins which bring blood to the heart from the lungs. The catheter that has been developed by Dr. Lesh and Atrionix uses sound waves emitted through a balloon placed at the base of one or more of these veins. By ablating a narrow ring of tissue where the vein meets the atrium these abnormal impulses that start in the pulmonary veins can not reach the atrium, and AF cannot start."

"Rather than looking for the specific focus, which is like finding a needle in a haystack," says Lesh, "we can simply block the entire electrical connection between the vein and the atrium, so the focus just cannot get out."

Dr. Lesh calls this method "anatomic pulmonary vein isolation." "The Atrionix technology has the potential to revolutionize the therapy of patients with the most common of all cardiac arrhythmias and drugs either don't work well or are not tolerated by our patients. I am extremely grateful that Atrionix has chosen to commercialize this novel technology, which we hope will allow us to rapidly and safely cure these patients who otherwise would have the arrhythmia their entire life," added Lesh.

"When Dr. Lesh described his circumferential vein isolation approach to me several years ago, Atrionix began a serious patent process specifically related to methods and technologies for for blocking the pulmonary vein focus. Todays issuance, although extremely broad, is only the tip of the Atrionix patent iceberg," says Dr. Michael Ross, president and CEO who co-founded the company with Dr. Lesh, Dr. Jonathan Langberg of Emory University and James Peacock, a biomedical engineer and patent attorney.

"As Dr. Lesh's approach to treat AF is now widely known and accepted, a number of competitors have begun working in this area. With the issuance of the '457 patent, which claims a method for forming the circumferential conduction block using a balloon or other expandable member with any of a wide variety of ablation sources, the company is in a position to protect our pioneering technology for pulmonary vein isolation," says Dr. Ross.

Atrionix, which has raised nearly $12 million since 1997, has recently initiated its U.S. clinical investigation of its pulmonary vein ultrasound balloon based ablation system, and has treated 20 patients in Europe to date.

Major Atrionix investors include Brentwood Venture Capital, Magic Venture Capital and Saratoga Ventures of Menlo Park, Calif., Johnson & Johnson Development Corporation, The Redwood Shores, Calif. venture arm of health care products concern Johnson & Johnson (NYSE:JNJ), and Premier Medical Partner Fund, San Diego, the venture arm of the large hospital strategic buying organization.