Healthcare Industry News: Mitral Valve
News Release - October 25, 2006
Evalve Announces New Data Showing its First-in-Class Percutaneous MitraClip(TM) Device Reduces Mitral Regurgitation Without SurgeryData Presented at Transcatheter Cardiovascular Therapeutics Annual Meeting Also Demonstrates Durability of Repair
135 Patients treated to date with MitraClip in the EVEREST Clinical Study
WASHINGTON, and MENLO PARK, Calif., Oct. 25 (HSMN NewsFeed) -- Evalve, Inc., a privately held medical device company, today announced that investigators presented core laboratory data at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in Washington, D.C. showing Evalve's MitraClip can significantly reduce mitral regurgitation (MR) and that the device is durable for up to three years.
To date, 135 patients have been treated with a MitraClip in the EVEREST (Endovascular Valve Edge-to-Edge REpair STudy) Clinical Study. The EVEREST phase II pivotal study is ongoing to evaluate the safety and efficacy of treating mitral regurgitation in the cardiac catheterization laboratory without open heart surgery. All EVEREST patients had previously been referred for surgery to treat their MR.
Investigators presented data on the first 92 non-randomized patients with completed 30 day follow-up and echocardiographic core lab analysis. The results show:
- Significant reduction of MR in patients with the two most common types
of MR: degenerative and functional,
- Reduction to < /= 1+ on a scale of 1+ to 4+ in the majority of cases
- 73% of patients avoided Mitral Valve surgery
- Improving procedural success rates,
- 90% success rate in the last 30 procedures reported
- Continued low rate of complications,
- 95% Freedom from Major Adverse Events at 30 days
- Decreasing procedure times, and
- Preservation of surgical options when needed.
Evalve is currently conducting the pivotal EVEREST II clinical trial evaluating the safety and efficacy of the MitraClip device versus surgical Mitral Valve repair or replacement. This prospective, randomized, multi- center study will enroll 279 patients at up to 37 sites in the United States and Canada. Patients are randomized 2:1 to receive the MitraClip device. Enrollment in the study is 20% complete and the Company anticipates completing enrollment by the end of 2007. The Company plans to file a PMA (pre-market approval) application in the United States once all patients are followed for one year and to seek CE Mark approval in Europe in 2007.
According to Donald Glower, M.D., professor of cardiovascular surgery, Duke University Medical Center, and Co-Principal Investigator of EVEREST II, "To date the EVEREST trial shows that the MitraClip device can achieve a significant reduction in mitral regurgitation in appropriate patients with initial durability out to 3 years. Growing experience with the MitraClip confirms that it offers a new option for treating selected patients with less morbidity than currently available surgical techniques. In the future, the MitraClip may also have utility as an alternative for patients who have high surgical risk and may even have some application in the operating room to decrease the morbidity of some surgical procedures."
"We are on track and executing plans to make this first-in-class device available in Europe in early 2008 and in the United States by 2010," said Ferolyn T. Powell, Evalve's President and Chief Executive Officer. "We look forward to presenting additional important data at upcoming medical meetings, including the 2006 American Heart Association Scientific Sessions in Chicago."
About the MitraClip Procedure
Evalve's Percutaneous Mitral Repair (PMR) is performed by interventional cardiologists in the catheterization laboratory using general anesthesia. 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 return to modified activity within one week. The MitraClip device appears to improve quality of life and help MR patients avoid or delay surgery, preserving surgical options (valve repair or replacement) if it becomes necessary.
About Mitral Regurgitation
MR, the most common type of heart valve insufficiency, occurs when the heart's Mitral Valve does not close properly. Blood leaks backward through the Mitral Valve with each heartbeat, causing the heart to work harder to circulate oxygen to the body. Both the American Heart Association and the American College of Cardiology recommend open-heart surgery to repair or replace the Mitral Valve for patients who suffer from moderate to severe (3+) and severe (4+) MR.
An estimated 4 million people in the United States have significant (>2+) MR, with an annual incidence of 250,000 newly diagnosed patients. However, only 20 percent of these patients, or approximately 50,000, undergo surgery each year; the other 200,000 remain affected by MR. For more information about mitral regurgitation or the EVEREST II study, please visit www.mitralregurgitation.org.
Evalve was incorporated in 1999 to design, develop, manufacture, and market innovative 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., visit www.evalveinc.com .
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