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Peer Review Meetings


W. Randolph Chitwood Jr., M.D., FACS, FRCS (Eng)
Senior Associate Vice-Chancellor for Health Affairs
Director, North Carolina Cardiovascular Diseases Institute
Chief, Division of Cardiothoracic and Vascular Surgery
Greenville, North Carolina

Curriculum Vitae

U-CLIPTM Expedites Minimally Invasive Mitral Valve Repair

SUNNYVALE, Calif., March 20 -- The world's first sutureless mitral annuloplasty repair was performed Monday by W. Randolph Chitwood, Jr., M.D., Professor and Chair of the Department of Surgery and Chief of Cardiothoracic Surgery at the Brody School of Medicine at East Carolina University in Greenville, NC. Dr. Chitwood used Coalescent Surgical's U-CLIPTM Device to replace conventional sutures and complete the robotic-assisted mitral valve repair in record time.

"Although this was only our first annuloplasty repair with the U-CLIPTM, we were able to reduce our average ring placement time by 38% compared to our conventional technique using standard sutures," said Dr. Chitwood, who also used Intuitive's da VinciTM Surgical System to perform the minimally invasive procedure. "Continued development of both this technique and technology will certainly open minimally invasive mitral valve repair to a greater number of surgeons and patients alike."

"Unlike conventional repairs, the post-operative Trans-Esophageal Echo (TEE) demonstrated no shadow in the area immediately above the annuloplasty ring," said Robert A. Duncan, M.D., Chief of Cardiac Anesthesia at Pitt County Memorial Hospital. "This shadow is usually associated with excess suture material extending well into the atrial bloodstream. With the elimination of suture, through the use of the U-CLIPTM, this finding appears to be a thing of the past."

Each year in the United States, there are more than 50,000 procedures performed on the mitral valve, which regulates blood flow from the left atrium, or holding chamber, to the left ventricle, the heart's main pumping chamber. The most common indication for surgery is mitral regurgitation, or leakage, which can result in less systemic blood flow and thickening of the ventricular wall. If left untreated, mitral regurgitation can lead to congestive heart failure, which currently affects nearly 5 million Americans and causes more than 1 million hospitalizations each year.

Conventional mitral valve surgery has involved the removal and subsequent replacement of the diseased valve with a mechanical prosthesis, often leading to a lifelong regimen of anticoagulant therapy and possible repeat surgery. In the last decade, however, there has been a significant shift from this conventional, invasive replacement to a less invasive repair where the mitral valve's form and function are restored physiologically, reducing both the need for follow-up medication and potential for repeat surgical procedures.

Many experts believe that a minimally invasive approach will expand the indication for mitral valve repair to a much larger group of patients who are presently unlikely candidates for conventional, invasive mitral valve operations due to the traditional length of cardiopulmonary bypass (CPB) time. The reduction or elimination of CPB time remains a key objective in major cardiac procedures, including mitral valve surgery.

"Reducing procedure time through the elimination of knot tying and suture management is an undeniable advantage of our product," said Laurent Schaller, Vice President of Research and Development for Coalescent Surgical. "This is especially true in endoscopic and robotic techniques where limited access, visibility, and dexterity can provide significant challenges."

Based on Coalescent Surgical's proprietary self-closing clip technology, U-CLIPTM devices have been used in more than 100,000 surgical applications to date. While the majority of usage has occurred in coronary anastomoses in cardiac surgery, U-CLIPTM devices have experienced adoption across multiple market segments including thoracic, peripheral vascular, AV access, transplant, pediatric, and general surgery.

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