EVANSTON, Ill. and WASHINGTON, Sept. 30 /PRNewswire/ -- A tiny clip device that can be delivered by a catheter and deployed in the heart to repair a malfunctioning and leaking mitral valve is building a favorable safety and feasibility profile as it nears completion of a nationwide Phase I trial.
To date, a total of 24 patients who suffered from severe mitral valve regurgitation (MR) have received the clip as part of a clinical study under an FDA-approved investigational device exemption (IDE). The clip is a product of medical device company Evalve Inc., located in Redwood City, CA. (http://www.evalveinc.com/). Based on these promising results, a larger, Phase II safety and efficacy trial may be initiated later this year.
Severe mitral valve regurgitation (MR) is a debilitating condition that causes shortness of breath, fatigue and palpitations. In the United States, about 250,000 people develop significant MR each year and almost 50,000 require surgery. The clip is designed to secure the valve’s leaflets so that blood leakage is minimized and the heart pumps more efficiently.
“To be able to repair the heart without a large chest incision and to send the patient home the next day is a great thing,” says Principal Investigator Ted Feldman, MD, Director of the Cardiac Catheterization Lab at Evanston Hospital, part of the Evanston Northwestern Healthcare system. He adds, “But it’s even more gratifying to see that after a full year, the first patients who participated in this trial are doing well and leading more active lives. Dr. Feldman performed the first percutaneous mitral valve repair procedure in the United States.
“This is one of the interventional cardiology devices in the pipeline that will change the face of cardiology in the coming years,” he notes. “We are beginning to see an array of devices that are intended to repair or replace malfunctioning valves and other structures of the heart without surgical intervention. Recovery times could be reduced from weeks to just days.”
Dr. Feldman presented an update of the trial today at the 16th Annual Scientific Symposium of Transcatheter Cardiovascular Therapeutics (TCT) at the Washington Convention Center in Washington, D.C. during a presentation entitled “Percutaneous Edge-to-Edge Mitral Valve Repair Using the Evalve Clip: Current Status of the EVEREST Phase I Clinical Trial.”
“As a group, we have successfully deployed the clip in 24 of 27 patients,” he reported. “The other three patients did not receive adequate correction of the mitral valve from the device, so we elected not to deploy it. All three patients were able to have elective, routine, successful mitral valve surgery. Adverse events at 30 days for the clip procedure are what we would expect to see and compare favorably to those observed with traditional mitral valve surgery.”
Along with Dr. Feldman, the team involved in the trial at Evanston includes Drs. Timothy Sanborn, Michael Salinger, Andrew Hamilton, Alan Zunamon and Jesse Marymount. Other U.S. investigators participating in the study are: Hal Wasserman, MD, Columbia University Medical Center; Howard Herrmann, MD, University of Pennsylvania; William Gray, MD; Swedish Medical Center, Seattle; Peter Block, MD, Emory University Hospital; Patrick Whitlow, MD, The Cleveland Clinic Foundation; and Elyse Foster, MD, UCSF Echo Core Lab.
To be eligible for the investigational procedure, candidates must have moderate-to-severe or severe MR and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle (heart muscle).
Performed in the cardiac catheterization lab, the initial procedures have taken approximately 2-4 hours. Under full anesthesia, a catheter (a thin, flexible plastic tube) is introduced through the skin in the thigh area and guided through the femoral vein to the affected area of the heart. A smaller delivery catheter that holds the clip is slipped through this tube so that the clip can be guided into place and attached to the leaflets (the “swinging doors”) of the mitral valve. Once the clip is attached, the delivery catheter is removed. The entire process is monitored by an echocardiogram. The hospital stay has generally been two nights and most patients returned to normal activity within one week.
Evanston Northwestern Healthcare (http://www.enh.org/) is comprised of Evanston Hospital, Glenbrook Hospital, Highland Park Hospital, ENH Medical Group, ENH Foundation, ENH Home Services and ENH Research Institute. Through its affiliation with Feinberg School of Medicine, Northwestern University, Evanston Northwestern Healthcare supports extensive medical education and research programs.
To find a study site in your geographic area, go to http://www.evalveinc.com/ and click on “EVEREST I” in the Learn More tab.
Caution: Investigational Device. Limited by Federal (US) Law to Investigational Use
Evanston Northwestern Healthcare
CONTACT: Anne Dillon of Evanston Northwestern Healthcare,+1-847-570-3146, or adillon@enh.org, or Office of Public Relations,+1-847-570-3141, or fax, +1-847-570-3285; or Jim Weiss, +1-415-362-5018, orjim@weisscom.net, for Evalve, Inc.
Web site: http://www.evalveinc.com/
Web site: http://www.enh.org/
