Feature | April 01, 2014

Melody Transcatheter Pulmonary Valve Shows Positive Clinical Outcomes in Real-World Patients

April 1, 2014 — Medtronic Inc. announced the one-year results of the Melody transcatheter pulmonary valve (TPV) U.S. post-approval study, which found that real-world use of the Melody TPV was associated with high procedural success, excellent valve function and few repeat procedures at the primary endpoint of six months. These results were sustained out to one year.

The Melody TPV was the first transcatheter valve to be approved by the U.S. Food and Drug Administration (FDA) and the first transcatheter valve available anywhere in the world. The therapy has treated more than 6,000 patients worldwide to date, more than half of who are children with congenital heart disease (CHD).

Presented as a late-breaking clinical trial at the American College of Cardiology (ACC) 63rd annual scientific session, the study results demonstrated a procedural success rate of 98 percent and showed that nearly all patients were free from major stent fracture (99 percent), transcatheter pulmonary valve dysfunction (98 percent) and reintervention (100 percent) at six months.

Following FDA approval in 2010 of the Melody TPV under a humanitarian device exemption (HDE) — the device equivalent of regulations for “orphan” drugs — the post-approval study prospectively enrolled 120 patients at 10 U.S. sites not included in the U.S. Melody TPV investigational device exemption (IDE) clinical trial. The patients had a mean age of 20 years (ranging from ages 5 to 45). The post-approval study results confirm the positive findings of the original Melody TPV U.S. IDE clinical trial, reinforcing the device’s ability to safely prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract (RVOT) caused by CHD.

“The positive results garnered in this real-world setting mirror those seen in other studies of the Melody valve,” said Aimee K. Armstrong, M.D., associate director, University of Michigan C.S. Mott Children’s Hospital Cardiac Catheterization Laboratories. “The one-year results show strong performance of the valve, which is intended to delay the time until open-heart surgery is needed. Decreasing the number of open-heart surgeries that our patients need has a significant impact on their lives and quality of life.”

Adverse events seen in the post-approval study ranged from fever to arrhythmia; and endocarditis (n=3) to confined conduit tear (n=6), the latter of which were all resolved with the use of a covered stent.

CHD is the most common birth defect in the United States; it affects an estimated 40,000 babies each year. Approximately 20 percent of those infants have deformities that disrupt the blood flow from their RVOT to the pulmonary arteries. A subset of these children will receive a connecting conduit early in life to improve that blood flow. If a patient’s RVOT conduit fails later in life but is still of adequate size to address the patient’s needs (i.e., the patient has not outgrown the conduit), then a Melody TPV may be implanted to help delay a surgical pulmonic valve replacement, which is a much more invasive procedure than transcatheter valve replacement.

“Open-heart surgery can come with significant risks, not to mention pain and discomfort, so the quality of life for these children with CHD can be compromised given the number of surgeries they typically have to endure over their lifetime,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. “The Melody TPV is making a big difference in the lives of these young patients, and we’re committed to continuing to provide successful therapies for this underserved patient group.”

Following the late-breaking trial, a moderated poster, titled “Current Results of the MELODY Registry – an International Multicenter Registry of Transcatheter Pulmonary Valve Implantation (TPVI),” also was presented at ACC by the German Heart Center from Berlin. The multicenter MELODY Registry represents the largest patient series after TPV implantation to date and further confirmed the safety of the Melody TPV in more than 1,000 CHD patients in real-world clinical practice.

For more information: www.medtronic.com

Related Content

Medtronic, CoreValve Evolut R TAVR system, U.S. IDE Study, TCT 2016
News | Heart Valve Technology| November 03, 2016
Medtronic plc unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R...
congenital heart patients, cardiac cath lab, anesthesia sedation practices, joint document, SCAI, SPA, CCAS
News | Congenital Heart| November 03, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Pediatric Anesthesia (SPA) and the...
SENTINEL trial, transcatheter embolic protection, TCEP, TAVR, stroke, TCT 2016
News | Embolic Protection Devices| November 03, 2016
An international study has found that transcatheter cerebral embolic protection (TCEP) is safe, provides effective...
RESPECT trial, Amplatzer PFO Occluder, St. Jude Medical, TCT 2016
News | Structural Heart Occluders| November 02, 2016
St. Jude Medical Inc. announced the long-term data from RESPECT, a landmark trial, during a First Report session at the...
Medtronic, Harmony TPV, transcatheter pulmonary valve, clinical study results, TCT 2016
News | Heart Valve Technology| November 02, 2016
Medtronic plc recently announced new clinical data for the Harmony Transcatheter Pulmonary Valve (TPV) from its early...
St. Jude Medical, Amplatzer PFO Occluder, FDA approval, U.S. launch
Technology | Structural Heart Occluders| November 02, 2016
St. Jude Medical Inc. announced this week the U.S. Food and Drug Administration (FDA) approval and launch of the...
Edwards, Sapien transcatheter heart valve, PARTNER trial, five-year echo data, TCT 2016
News | Heart Valve Technology| November 01, 2016
Edwards Lifesciences Corp. announced new five-year hemodynamic data from the PARTNER Trial demonstrating excellent...
Medtronic, CoreValve Evolut R TAVR system, TCT 2016, FORWARD Study, STS/ACC TVT Registry
News | Heart Valve Technology| October 31, 2016
Medtronic plc presented new positive data from two large registries aimed at evaluating 30-day clinical performance...
Mitralign, Trialign tricuspid repair system, SCOUT I study, 30-day data, TCT 2016
News | Heart Valve Technology| October 28, 2016
Mitralign will present data on its Trialign Tricuspid Repair system at the 2016 Transcatheter Cardiovascular...
CHOP, Children's Hospital of Philadelphia, prenatal heart surgery, tumor removal, intrapericardial teratoma

Tucker Roussin, 3, is the first survivor of fetal surgery for a life-threatening tumor connected to his heart. Fetal medicine experts at Children's Hospital of Philadelphia successfully removed this tumor. Credit: Children’s Hospital of Philadelphia.

News | Congenital Heart| October 28, 2016
For the first time, fetal medicine experts have performed prenatal heart surgery to remove a life-threatening tumor,...
Overlay Init