Medtronic has unveiled results from two clinical trials, which evaluated its Melody Transcatheter Pulmonary Valve (TPV) Therapy, and Harmony TPV.
The ten-year data from Melody TPV study showed positive hemodynamic and safety outcomes, while the investigational Harmony TPV trial met safety and efficacy endpoints for hemodynamic function.
Medtronic vice president and general manager Sandra Lesenfants said: “As demonstrated by these late-breaking studies, we’re consistently building our body of new, short-, and long-term research around innovative, minimally-invasive TPV solutions for CHD patients.
“These Harmony data demonstrate our commitment to generating new therapies and growing our congenital heart disease program to support a lifetime of care that this patient population needs.”
Congenital heart disease (CHD) is a common type of birth defect in the US, and approximately 22% of CHD patients have structural malformations that disrupt the connection between the heart and the lungs, known as the right ventricular outflow tract (RVOT).
Some of the patients with RVOT require an open-heart surgery early in life to correct the malformations and a prosthetic conduit can be used to increase the blood flow from the heart to the lungs.
The Melody TPV is implanted to restore pulmonary valve function and delay surgical intervention, when the conduit fails to function.
Melody is the world’s first FDA approved transcatheter valve implanted in a human
The medical devices firm, under the Medtronic congenital heart disease programme, is evaluating the safety and effectiveness of the Harmony TPV for patients with RVOT malformations.
The Melody TPV clinical trial enrolled 150 implanted patients and pulmonary regurgitation (PR) was set as primary indication for intervention. The safety outcomes includd serious device-related adverse events, stent fracture, catheter reintervention, surgical conduit replacement, and mortality rate.
The clinical trial evaluated Melody for long-term functionality, or TPV dysfunction, defined as reoperation, catheter reintervention, or hemodynamic dysfunction.
Medtronic claimed that its Melody is the world’s first transcatheter valve implanted in a human and the first to be approved by the Food and Drug Administration (FDA).
Harmony TPV has been designed to treat patients with RVOT anomalies who develop severe PR, when a previous repair fails. The study of Harmony is aimed at evaluating the safety and effectiveness of a minimally invasive alternative to open-heart surgery.
The clinical trial evaluated the procedural success, safety, and performance of the Harmony TPV device, in 50 patients enrolled across 12 sites in the US, Canada and Japan.
Clinical trial principal investigator John P Cheatham said: “These pivotal data support the rationale for a potential new therapy designed specifically for the right ventricular outflow tract.
“If future study data continues to be strong, we’re hopeful that Harmony may potentially impact this critical, hard-to-treat segment of patients, who have limited treatment choices with current transcatheter technologies.”