Medtronic's Melody TPV Supported by 1-Year Postapproval Study Data

March 30, 2014—Medtronic, Inc. (Minneapolis, MN) announced the 1-year results of the Melody transcatheter pulmonary valve (TPV) United States postapproval study. The data were presented as a late-breaking clinical trial at ACC.14, the American College of Cardiology 63rd annual scientific session.

According to Medtronic, the study 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 6 months and these results were sustained out to 1 year.

The study results demonstrated a procedural success rate of 98% and showed that nearly all patients were free from major stent fracture (99%), transcatheter pulmonary valve dysfunction (98%), and reintervention (100%) at 6 months. The company advised that adverse events seen in the postapproval 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.

The Melody TPV device received humanitarian device exemption (HDE) approval from the US Food and Drug Administration (FDA) in 2010. The postapproval study prospectively enrolled 120 patients at 10 sites in the United States that were not included in the United States Melody TPV investigational device exemption (IDE) clinical trial. The patients had a mean age of 20 years (range, 5 to 45 years). The company noted that more that half of the 6,000 patients treated with TPV since the technology became available were children with congenital heart disease (CHD).

Medtronic stated that the postapproval study results confirm the positive findings of the original Melody TPV US IDE clinical trial and reinforce the device’s ability to safely prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract caused by CHD.

In Medtronic’s press release, Aimee K. Armstrong, MD, commented, “The positive results garnered in this real-world setting mirror those seen in other studies of the Melody valve. The 1-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.” Dr. Armstrong is Associate Director of the University of Michigan C.S. Mott Children’s Hospital Cardiac Catheterization Laboratories in Ann Arbor, Michigan.

Also at ACC.14, the German Heart Center of Berlin, Germany, presented a poster, “Current Results of the MELODY Registry - an International Multicenter Registry of Transcatheter Pulmonary Valve Implantation.” The multicenter MELODY registry further confirmed the safety of the Melody TPV in more than 1,000 CHD patients in real-world clinical practice, advised Medtronic.