Medtronic announces U.S. trial data on transcatheter valve for congenital heart disease

Two critical properties of cancer cells are their ability to divide without restraint and to spread away from the primary tumor to establish new tumor sites. Now, researchers from the Mayo Clinic campus in Florida have found a protein they say acts as a deadly master switch, both freeing cancer cells from a tumor while

Full Post: Scientists identify dangerous ‘two-faced’ protein crucial to breast cancer spread and growth

Today at the annual scientific sessions of the American Heart Association, the first U.S. clinical trial data on the Melody transcatheter pulmonary valve were presented. These findings also represent the first U.S. data on transcatheter valves in a population with congenital heart disease and the first reported U.S. data on the use of a transcatheter valve in the pulmonary position. The Melody valve is currently investigational in the U.S.

Data were presented on 66 patients enrolled at centers in Boston, Seattle, New York, Columbus, and Miami. Encouraging from a safety perspective was a high acute procedural success rate of 98 percent. At six-months follow up, maintenance of excellent valve competence was demonstrated as was a corresponding, clinically-significant, reduction of more than 18 percent in right ventricular volume. Valve competence was assessed by median pulmonary regurgitation fraction, which was down to 0 percent from a baseline of 30 percent.

Presenter of the data, Dr. Doff McElhinney, pediatric interventional cardiologist at Children’s Hospital Boston, commented, “These data are very encouraging. Young patients with the types of congenital heart disease included in this study frequently require multiple open heart surgeries during the course of a lifetime. The Melody transcatheter valve is designed as a non-surgical alternative that will, at the very least, allow deferment of the next surgical intervention while protecting the heart from the strain of extra work. These multi-center data demonstrate that the Melody valve can be safely implanted with a high rate of procedural success. We have been encouraged by the excellent early function of the Melody valve and by the six-month clinical outcomes, which demonstrate clear improvements in heart size and valve function.”

Of the U.S. congenital heart disease patients who require treatment each year for pulmonary valve dysfunction, approximately 1,500 are candidates for valve replacement with the Melody device. John Liddicoat M.D., general manager of the CardioVascular Structural Heart Disease business at Medtronic, commented, “The success of the Melody valve results directly from the collaborative approach Medtronic has taken with physicians and scientists to develop technology. This successful approach has also built the foundation for a much larger program to develop transcatheter valves for all valve positions.” Dr. Liddicoat concluded, “Medtronic is well positioned to be the world leader in heart valve replacement and repair. The benefits for patients are immense as we continue to develop innovative technology that is safe, reliable and easy for doctors to deploy with repeatable and confident accuracy.”

The Melody valve was designed for patients with congenital heart defects who have a surgically-placed conduit between the right ventricle and pulmonary artery. When the valves in these conduits fail, the Melody valve provides a non-surgical means to restore valve function and prolong the life of a conduit, reducing the number of open heart surgeries these patients require. Using the Ensemble? system, a physician navigates the Melody valve to the heart by threading it through the body’s blood vessels, eliminating the need to open the chest, minimizing trauma and offering a quicker recovery than open heart surgery.

Melody, the world’s first commercially available transcatheter valve, is available in 60 centers outside the United States following Canadian and European approval. Medtronic B.V., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) received CE Mark on the Melody Valve and Ensemble System in 2006.


An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered to patients at NewYork-Presbyterian Hospital/Columbia University Medical Center. Known as the PARTNER (Placement of AoRTic traNscathetER valves) trial, this Phase 3 multicenter study is being led by national co-principal investigators Dr. Martin Leon and Dr. Craig Smith and is

Full Post: New method for implanting aortic heart valves

Children with heart defects may someday receive perfectly-matched new heart valves built using stem cells from their umbilical cord blood, according to research presented at the American Heart Association’s Scientific Sessions 2008. When infants are born with malfunctioning heart valves that can’t be surgically repaired, they rely on replacements from animal tissue, compatible human organ

Full Post: Stem cells from umbilical cord blood may help build new heart valves

The use of cardiopulmonary bypass does not cause short-term neurological problems in children and teenagers after surgery for less complex heart defects, according to pediatric researchers. The new finding contrasts favorably with previous studies that showed adverse neurological effects after newborn surgery for more complex heart conditions. “This is good news for school-aged children who

Full Post: Cardiopulmonary bypass for child heart surgery does not affect IQ

Disturbing evidence of higher mortality and lower surgery rates in women versus men with mitral valve prolapse and severe leakage may be related to the complexity of evaluating the condition’s severity in women, according to findings of a Mayo Clinic study published this month in the Annals of Internal Medicine. Mitral valve prolapse affects approximately

Full Post: Study looks at mitral valve prolapse

Adding to its recent endovascular aortic repair (EVAR) innovations, Medtronic, Inc. has announced the U.S. launch of the Talent Abdominal Stent Graft on the Xcelerant Hydro Delivery System. EVAR is a treatment for aortic aneurysm, a dangerous bulge or weakening in the body’s main artery that can rupture with fatal consequences if left untreated. In

Full Post: Medtronic launches new device in U.S. to improve treatment of aortic aneurysm