Healthcare Industry News: Mitral Valve
News Release - April 1, 2008
MitraClip Device Preliminary Data Suggests Improved Heart Function and Relief from Heart Failure Symptoms in Functional Mitral Regurgitation PatientsStudy Continues to Show Lasting Reductions in Mitral Regurgitation Across a Spectrum of Patients
CHICAGO, April 1, 2008 (HSMN NewsFeed) -- Percutaneous mitral repair using the MitraClip® device may successfully reduce mitral regurgitation (MR) in patients suffering from functional MR (FMR) over a two-year period, according to preliminary data from the ongoing Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) presented today at the SCAI Annual Scientific Sessions in Partnership with the ACC i2 Summit (SCAI-ACCi2). The EVEREST trial is evaluating the safety and efficacy of the MitraClip device for the treatment of MR, a condition in which blood leaks backward through the Mitral Valve, requiring the heart to work harder and ultimately leading to heart failure.
The data analysis was based on 23 patients with moderate-to-severe or severe FMR (grade 3+ to 4+). James Hermiller, M.D., director of the interventional fellowship program at St. Vincent Heart Center of Indiana in Indianapolis, presented the findings. Dr. Hermiller reported that 83 percent of the 23 FMR patients had successful MR reduction after the MitraClip procedure. Additionally, the majority (74 percent) of successfully treated FMR patients showed MR reduction to less than or equal to 2+ MR. Importantly, the MR reduction was maintained, with a Kaplan-Meier durability of MR reduction in 89 percent of patients at one and two years.
"The results have surpassed our initial expectations," said Dr. Hermiller. "This compelling preliminary data suggests that the treatment of functional MR with the MitraClip may be an effective option for patients."
Other results, showed that at one year, clinical symptoms improved or stabilized compared to baseline in 92 percent of successfully treated FMR patients (matched data, n=12). Symptomatic relief was seen in 70 percent of FMR patients who had a history of heart failure.
In addition to the reduction in MR severity and clinical symptoms, left ventricular function significantly improved in successfully treated FMR patients, as defined by objective measures indicating significant reverse left ventricular remodeling at one year.
All 23 FMR patients were discharged home with self-care after a mean length of stay of 3 days -- a contrast to surgical treatment which often requires more extensive in-hospital stays and post-discharge care through in-home nursing or a step down facility. While the minimally-invasive nature of the MitraClip procedure is expected to preserve standard surgical options for patients should they be necessary, 83 percent of the FMR patients were surgery free at a median follow-up of one year following the MitraClip procedure.
"It is generally well accepted that percutaneous interventions provide safer and less traumatic options for patients. We are very pleased with the low complication rate and percutaneous observed in the initial percutaneous Mitral Valve repair procedures," said Ferolyn Powell, president and chief executive officer of Evalve. "The reduction of MR with durable results and improved heart function highlight the potential of the MitraClip device. We believe we are making strides with a new, less-invasive method of valve repair for both functional MR and degenerative MR patients."
About Mitral Regurgitation
MR is the most common type of heart valve insufficiency, affecting more than 4 million people in the United States. There are 250,000 new significant MR diagnoses each year; however only 20 percent, or approximately 50,000, of these patients undergo surgery each year. The other 200,000 remain affected by the chronic volume overload caused by MR, which requires the heart to work harder, ultimately leading to heart failure.
Additionally, an estimated 5 million people in the U.S. are diagnosed as suffering from heart failure. Approximately half of these patients suffer from Functional MR which is associated with a significantly increased risk of mortality.
The EVEREST study continues at more than 40 centers in North America with more than 300 patients treated and nearly 400 MitraClip devices implanted to date. Investigators are currently enrolling patients in the randomized arm of the study with the goal of completing enrollment by the end of 2008.
Enrollment in the study is open to several patient groups:
-- Patients with either degenerative or functional MR
-- Patients who are good surgical candidates and are open to the option of a less invasive approach
-- Patients who are higher risk surgical candidates but are considered operable
More information about the EVEREST II trial is available at www.mitralregurgitation.org
About the MitraClip Procedure
Percutaneous mitral repair with Evalve's MitraClip device is performed by interventional cardiologists in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart- lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip device may improve quality of life and may help MR patients potentially avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.
About Evalve, Inc.
Evalve, Inc. (Menlo Park, Calif.) was incorporated in 1999 to design, develop, manufacture, and market innovate devices to enable percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. The company's present development and clinical efforts are focused on Mitral Valve repair. For more information about Evalve, Inc., and for an animated explanation of the Percutaneous Mitral Repair procedure using the MitraClip device, visit www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (www.thefoundry.com).
MitraClip and Evalve are registered trademarks of Evalve, Inc.
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