CardioVations, a division of Ethicon, Inc., a Johnson & Johnson
company, announced today the latest advancement to its line of heart stabilization systems. The EMBRACE™ Heart Stabilizer stabilizes desired areas of the heart, which, in turn, creates a relatively stationary coronary artery during beating heart or "off-pump" coronary bypass (OPCAB) surgery and gives cardiac surgeons confidence for the most demanding procedures. The device uses stabilization "feet" to hold in place the epicardium parallel to the coronary artery, allowing them to bypass the blocked artery without resorting to the traditional method of stopping the heart and employing the heart/lung machine.
This new device builds on the innovative standards set by the predecessor device, FLEXSITE™ Heart Stabilizer. The new EMBRACE™ stabilizer provides surgeons extreme confidence for the most demanding off-pump coronary artery bypass (OPCAB) procedures, with a 360-degree rotation and tilt for optimal visualization and access to lateral wall vessels. The malleable foot pods allow for custom contouring to the epicardial surface, and the low-profile suction pods gently spread tissue at the anastomotic site. The redesigned low-profile stabilizer arm provides for quick, one-step stabilization and control with a unique activation lever. This simple, single-hand activation lever provides control to fine-tune adjustments and positioning.
"For patients undergoing coronary revascularization, off-pump surgery has been shown to be beneficial," stated Valavanur Subramanian, M.D., director, Department of Surgery, Lenox Hill Hospital, New York, NY. "Devices such as the EMBRACE™ stabilizer allow for complete revascularization during an off-pump procedure and are valuable additions to the ongoing development of beating heart surgery."
It is estimated that the "off-pump" method of coronary bypass is used in 25 percent of all coronary bypass surgeries.1 Allowing the patient's own lungs and heart to maintain circulation rather than artificial components has been shown to be beneficial to patients.
The surgeon should not position the stabilizer foot pods over a coronary artery, or over newly infarcted or aneurysmal heart tissue. Physicians should be adequately trained and have familiarity with less invasive cardiac surgical procedures. They should consult medical literature relative to techniques, complications and hazards prior to performance of any cardiac surgical procedure. Many variables, including patient anatomy, pathology and surgical techniques may influence procedural outcomes. As with any surgical procedure, there are risks associated with heart surgery using these devices. Risks associated with this procedure are typical of those associated with conventional coronary artery surgery.