Navigation Links
MitraClip(R) Therapy Data Demonstrate Clinical Benefit in High-Risk Patients With Mitral Regurgitation
Date:5/20/2009

EVEREST High-Risk Registry Data Show Improved Symptomatic Status, Cardiac Function and Reduced rate of Hospitalization for Congestive Heart Failure in both Functional and Degenerative MR Patient Populations

BARCELONA, Spain, May 20 /PRNewswire/ -- Results show percutaneous mitral repair using the MitraClip(R) system in symptomatic high-risk surgical patients with either functional mitral regurgitation (FMR) or degenerative mitral regurgitation (DMR) improves patient clinical status. The results from the 78 patient EVEREST II High Risk Registry demonstrated improvement in left ventricular function and reduced hospitalization for congestive heart failure for both MR groups at twelve months. Additionally, a reduction in mortality compared to the predicted mortality risk of surgery was reported for the registry. The results of the High-Risk Registry were presented today at the third annual meeting of EuroPCR, the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

MR is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe, the majority of which have FMR. There are more than 600,000 new diagnoses of significant MR each year in Europe and the US; however only 20 percent of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

The data were presented today by Saibal Kar, M.D., director of interventional cardiac research at Cedars-Sinai Medical Center and the lead enrolling investigator of the EVEREST trials.

"The High Risk Registry data support our belief that the MitraClip therapy is a safe and clinically beneficial treatment alternative for select patients suffering from significant functional or degenerative MR," said Dr. Kar. "Patients otherwise unable to withstand more invasive treatments can benefit from the MitraClip therapy while avoiding the risk of increased morbidity and mortality often associated with surgical treatment."

Patients considered at high-risk for surgery are those with an increased likelihood of mortality and morbidity following surgery, usually because of advanced age and co-morbidities, which consequently limit their treatment options. Without MR reduction, these patients have a poor quality of life, are frequently hospitalized for heart failure and have reduced survival.

The High Risk Registry data showed similar 30-day mortality, as well as improved 12-month mortality among patients treated with the MitraClip therapy compared to a concurrent control group who was managed medically or underwent mitral valve surgery.

At 12 months, 74 percent of FMR patients with matched data were in NYHA functional class I or II, compared to only 9 percent at baseline. Similarly, at 12 months, 75 percent of DMR patients with matched data were in NYHA functional class I or II, compared to only 15 percent at baseline. This sustained improvement in functional class was accompanied by improved LV function for both groups. The rate of hospitalization for congestive heart failure in the year after treatment with the MitraClip system was reduced by 55 percent and significantly lower compared to the year prior to treatment.

"The high-risk registry data carries healthcare implications from both a quality of life and an economic perspective," said Ferolyn Powell, president and chief executive officer of Evalve. "It suggests the MitraClip therapy may be a good treatment alternative for patients with MR who are too high risk for surgery and also indicates the therapy potentially reduces healthcare costs by decreasing re-hospitalizations for congestive heart failure in this population. With more than 500 MitraClip cases performed worldwide, these findings add to the evidence from the US and Europe that indicates the MitraClip therapy may offer a minimally invasive alternative to reduce chronic volume overload caused by MR, while preserving traditional therapeutic options in selected patients."

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve's MitraClip(R) device is performed by physicians 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(R) device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc., headquartered in Menlo Park, Calif., has developed a proprietary system which enables 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. For more information about Evalve, Inc., and for an animated explanation of the procedure using the MitraClip(R) device, visit www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (www.thefoundry.com).

The MitraClip(R) system is currently undergoing clinical evaluation in the United States and Canada. Enrollment is ongoing in the REALISM study which allows EVEREST investigators and their patients continued access to the MitraClip(R) therapy. The MitraClip(R) system is available for commercial distribution in the EU.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.


'/>"/>
SOURCE Evalve, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. MitraClip(R) Therapy Data Shows Important Clinical Benefit in High Risk Patients With Functional Mitral Regurgitation at 12-Month Follow Up
2. First Swiss Patients Treated with the Percutaneous MitraClip(R) System
3. Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System
4. First European Patients Treated With the Percutaneous MitraClip(R) System
5. New Data Shows Ongoing Benefits of Percutaneous MitraClip(R) Device for Patients With Mitral Regurgitation
6. New MADIT II Clinical Data Analysis Shows Long-Term Survival Benefit for Implantable Defibrillator Therapy
7. Circassia Begins Phase II Clinical Trial With Ragweed Allergy Therapy
8. CVS Caremark Data Confirms Improved Outcomes for Women with Osteoporosis Who are Adherent to Therapy
9. New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure
10. Prostate Cancer Immunotherapy Significantly Prolongs Survival in Men With Advanced Prostate Cancer
11. Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... , Oct. 11, 2017  BioPharmX Corporation (NYSE MKT: ... that developed an innovative way to use nonlinear optical ... delivery of new drugs. ... Dermatology Conference will show how researchers from BioPharmX and ... Medical School used a suite of imaging techniques in ...
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance ... a medical-grade battery-powered display stand specifically designed for endoscopy environments. An ... technology into a clinical solution to support the improvement of patient ... Innovative Design ... Wireless Solution ...
(Date:10/4/2017)... 2017  South Korean-based healthcare product Development Company I.M. ... on Kickstarter. The device will educate the user about ... better efficiency compared to the dated and pricey CPR ... efficacy of the compression for a more informed CPR ... to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... are now treating sleep apnea using cutting-edge Oventus O2Vent technology. As ... serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... a leader in post-acute health care, have expanded their existing home health joint ... Health. , AccentCare has been operating a joint venture home health company with ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, the Health ... Miles by Moonlight to raise money for the American Heart Association Heart Walk. Teams ... Teams will work together to keep their treadmills moving for 5 hours. Treadmills will ...
Breaking Medicine News(10 mins):