FDA Clears Novare's Enclose® II Anastomotic Assist Device For Multiple-Vessel Heart Bypass Surgery

Bypass Attachment Device Offers Surgeons Improved Performance

CUPERTINO, Calif., February 23, 2004 - Novare Surgical Systems Inc., a privately held provider of innovative devices for cardiovascular and vascular surgery, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Enclose® II Cardiac Anastomosis Assist Device. For use by surgeons to attach a bypass vessel to the aorta during on-pump and off-pump (or "beating-heart") coronary artery bypass graft (CABG) surgery, the improved device incorporates a 40% lower profile for trouble-free handling in the surgical field, 20% larger suture area in a hexagonal shape for easier vessel attachment, and remote actuation by the surgeon.

"The new features of Enclose II incorporate design suggestions made by our surgeon customers," said Kerry Pope, president and chief executive officer. "Judging from the response we received at this year's annual meeting of the Society of Thoracic Surgeons, we have delivered the superior product they were looking for."

Luis Castro, M. D., cardiac surgeon at Sequoia Hospital, Redwood City, Calif. added, "The Enclose II design upgrades make it much easier to use. The profile is lower, yet it has substantially more space for suturing. The actuator tool makes it faster to position and the lower jaw design enables me to consistently get a "perfect punch" into the aorta. The Enclose II performed even better than I expected."

Robert Boova, M.D., Chief of Cardiothoracic Surgery, Mainline Health System Hospitals, Bryn Mawr, Penn., said, "The original Enclose is an outstanding product. In my practice, I've found the device substantially reduces the risk of embolization during off-pump coronary bypass surgery by eliminating the need for aortic partial-occlusion clamping. Enclose II has excellent new characteristics that increase the ease of use, and represents a significant advance in cardiac surgery."

The Enclose II is distributed in the United States by CardioVations, a division of Ethicon, Inc., a Johnson & Johnson Company.

About the Enclose II Cardiac Anastomosis Assist Device
Designed for use in on-pump and off-pump (or "beating-heart") CABG procedures, the handheld Enclose device allows the surgeon to create an enclosed bloodless field approximately one-centimeter square in the fully pressurized aorta without use of a side-biting, partial occlusion clamp. This type of clamping has been associated with a variety of post-operative complications, possibly due to the release of plaque from the aorta vessel walls.

With the Enclose device, the surgeon creates a sutured connection, or so-called proximal anastomosis, of a vein or arterial graft on the aorta using standard suturing techniques. Unlike connector technology that eliminates both the side-biting clamp and the traditional anastomosis technique, the Enclose device preserves the well-documented high-patency rates and hemodynamics of hand-sutured proximal anastomoses. Used by cardiac surgeons in more than 5,000 procedures to create a bypass connection with no adverse events reported, the Enclose Device was originally developed by renowned surgeon and inventor Thomas J. Fogarty, M.D.

About CardioVations
CardioVations, a division of Ethicon, Inc., a Johnson & Johnson Company, is a pioneer in cardiovascular surgery devices that reduce complications and improve outcomes for patients. CardioVations offers innovations in the areas of coronary artery bypass grafting (CABG), valve surgery, automated anastomotic devices and vessel management. Additional information on CardioVations can be found at http://www.cardiovations.com.

About Novare Surgical Systems Inc.
Based in Cupertino, Calif., Novare Surgical Systems was founded in 1999 to develop, manufacture and market devices for use during cardiovascular, thoracic and peripheral vascular surgery. Novare has introduced the Enclose® II Anastomotic Assist Device for use in on-pump and off-pump cardiac artery bypass surgery, and is selling its products in the United States, Europe, the Middle East, Asia, Africa and Japan. For more information, visit the company's web site at www.novaresurgical.com. Enclose is a registered trademarks of Novare Surgical Systems.