Medtronic Announces First U.S. Implant of Its Melody Transcatheter Valve for Patients with Congenital Heart Disease.MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE
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MDT n abbr (US) (= mountain daylight time) → ) announced today the first U.S. patient implant in a feasibility study "A Feasibility Study" is an episode of the original The Outer Limits television show. It first aired on 13 April, 1964, during the first season. It was remade in 1997 as part of the revived The Outer Limits series with a minor title change. to evaluate the use of the Medtronic Melody[TM] Transcatheter Pulmonary Valve and Ensemble[TM] Transcatheter Delivery System to treat patients requiring congenital pulmonary heart valve replacement Heart Valve Replacement Definition
Heart valve replacement is a surgical procedure during which surgeons remove a damaged valve from the heart and substitute a healthy one. .
The prospective, non-randomized, feasibility clinical trial will enroll 30 patients at three U.S. medical centers including:
* Children's Hospital Boston Children's Hospital Boston is a children's hospital located in the Longwood Medical and Academic Area of Boston, Massachusetts. Located at 300 Longwood Avenue, Children's is adjacent both to its teaching affiliate, Harvard Medical School, and to Dana-Farber Cancer Institute. (Boston, MA) with investigators James Lock, MD Cardiologist-in-Chief and Emile Bacha, MD Senior Associate in Cardiac Surgery
* Morgan Stanley Children's Hospital Morgan Stanley Children's Hospital is a pediatric hospital in New York City. It is a part of NewYork-Presbyterian Hospital and is affiliated with Columbia University. They are especially known for their expertise in pediatric heart surgery. of New York - Presbyterian (New York, NY) with investigators Dr. William Hellenbrand, MD Director of Catheterization catheterization
Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. Laboratory for Congenital Heart Disease congenital heart disease, any defect in the heart present at birth. There is evidence that some congenital heart defects are inherited, but the cause of most cases is unknown. and Ralph Mosca, MD Director of Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.
Of or relating to pediatrics. Cardiac Surgery
* Miami Children's Hospital (Miami, FL) with investigators Evan Zahn, MD Chief, Cardiology and Redmond Burke, MD Chief Cardiovascular Surgery
"We are excited about the promise of bringing this new, non-surgical procedure to the thousands of U.S. patients suffering from congenital heart disease with defects that disrupt the blood flow from the right ventricle to the pulmonary artery," said Dr. James Lock, Cardiologist-in-Chief at Children's Hospital Boston. "Our first implant has been conducted with positive results - both clinically and from a quality of life perspective - for the patient by delaying the need for an invasive open heart procedure to restore valve function."
"Effective management of congenital heart defects Congenital heart defects
Congenital means conditions which are present at birth. Congenital heart disease includes a variety of defects that babies are born with.
Mentioned in: Heart Failure, Heart Surgery for Congenital Defects over a patient's lifetime requires dedicated collaboration between cardiac surgeons and interventional cardiologists," added Dr. John Mayer, Senior Associate in Cardiac Surgery at Children's Hospital Boston. "Together, members of these two disciplines draw on a variety of treatment options and clinical pathways. We hope that the Melody valve will be an important addition to the choices available for our patients."
Oftentimes, this type of defect requires open heart surgery early in life to implant a prosthetic pros·thet·ic
1. Serving as or relating to a prosthesis.
2. Of or relating to prosthetics.
serving as a substitute; pertaining to prostheses or to prosthetics. or bioprosthetic valved-conduit to establish adequate blood flow from the heart to the lungs. However, the functional life span of these conduits is relatively limited, and as a result, most patients with this type of defect may require multiple open heart surgeries to place new valved conduits as they grow over their lifetime. To meet this clinical need, Medtronic will use this trial to evaluate the Melody valve and Ensemble delivery system as a catheter-based alternative treatment in order to restore effective pulmonary valve function and potentially prolong the functional life of the right ventricle to pulmonary artery conduits. This alternative treatment will thereby reduce the number of open heart surgeries these patients must undergo.
"The initiation of the feasibility trial and first successful implant continues to demonstrate Medtronic's commitment to providing new heart valve technologies for use in treating unmet patient needs," said Dr. John Liddicoat, vice president of Structural Heart Disease for the Cardiac Surgery business at Medtronic. "We hope that the Melody valve and Ensemble system will prove to be two more examples of Medtronic's commitment to improving clinical outcomes, and our focus on patient-centered lifetime management of structural heart disease."
Medtronic has partnered with Professor Philipp Bonhoeffer, professor and chief of cardiology and director of the Catheterization Laboratory, Great Ormond Street Hospital The Great Ormond Street Hospital for Children (GOSH) was founded in London in 1852. There are a few institutions which pre-date it as providing care for children, although not in-patient beds. for Children (GOSH) in London, and NuMed Canada, a pediatric catheter company in the development of the Melody valve and Ensemble system. A pioneer in transcatheter valve technology, Professor Bonhoeffer implanted the world's first transcatheter valve in September 2000. To date, more than 200 patients have been treated with the therapy.
While the Melody valve and Ensemble system are not currently available in the United States, Medtronic has received Canadian approval and CE Mark approval in Europe for commercial sale of the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.