News | Congenital Heart | February 24, 2023

Medtronic Relaunches First-of-its-kind Transcatheter Pulmonary Valve Replacement System for Congenital Heart Disease

Harmony Transcatheter Pulmonary Valve System is the first FDA-approved minimally invasive valve designed for the right side of the heart 

Harmony Transcatheter Pulmonary Valve System is the first FDA-approved minimally invasive valve designed for the right side of the heart

February 24, 2023 — Medtronic today announced the relaunch of its Harmony Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). 

Congenital heart disease (CHD) is the most common type of birth defect in the United States, affecting an estimated 40,000 infants each year[1] and 1.6 million who live with the disease[2]. Approximately one in five patients born with CHD have structural malformations that disrupt the connection between the heart and the lungs[3], or the RVOT. The current standard of care is open-heart surgery or other interventions early in life to address these malformations. For the 80% of CHD patients who require a native or surgically repaired RVOT at birth, many will need a pulmonary valve replacement later in life, which often requires another open-heart surgery. 

Harmony TPV was designed to treat patients with RVOT anomalies who develop severe pulmonary valve regurgitation, a condition where blood leaks back into the right lower chamber of the heart after being pumped into the lungs. The Harmony TPV provides these patients with a minimally invasive alternative. 

“For congenital heart disease patients with severe pulmonary valve regurgitation, utilizing a valve that works with their anatomy is key to preventing risks such as right-sided heart failure, and optimizing outcomes while minimizing the disruption to their lives,” said Matthew J. Gillespie, M.D., Director of Interventional Cardiology and Co-Director of the Valve Center at Children’s Hospital of Philadelphia.  “I am pleased to be able to once again offer Harmony TPV as an option to patients who require pulmonary valve replacement. 

The Harmony TPV System received U.S. FDA approval in 2021 based on the Harmony TPV clinical study that demonstrated safety and effectiveness up to 6 months with no significant reinterventions. 

Medtronic initiated a voluntary recall of the Harmony Delivery Catheter System (DCS) in March 2022 due to six reported cases of the bond holding the capsule at the end of the delivery catheter breaking. Medtronic worked collaboratively with the FDA to remediate the issue and earn FDA approval to return the device to market. 

“The relaunch of Harmony TPV underscores our continued commitment to advancing solutions for all people who experience heart disease, and we are proud to be driving innovation forward by offering the first non-surgical solution designed for congenital heart disease patients with severe pulmonary valve regurgitation,” said Nina Goodheart, SVP and President of the Structural Heart & Aortic business at Medtronic. “ 

The Harmony TPV device is now commercially available for use in the United States and has received regulatory approval in Japan. 

For more information: 

Recent Technology Advances in Congenital Heart: 

FDA Clears First Device to Treat Right Ventricular Outflow Tract Congenital Heart Disease  

VIDEO: Harmony Transcatheter Pulmonary Valve Has Good Outcomes at 1 Year — Interview with Tom Jones, M.D. 

Medtronic Harmony Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes at One Year 

FDA Expands Indication for Melody Transcatheter Valve for Failed Surgical Valves 

VIDEO: Use of Virtual Reality to Aid Congenital Heart Disease — Interview with David M. Axelrod, M.D. 

Bioresorbable Pulmonary Valve Replacement May Enable Cardiovascular Regeneration 

VIDEO: Transcatheter Closure of Holes in the Heart — Interview with Ziyad Hijazi, M.D. 

Nemours Children's Health System Uses 3-D Printing to Deliver Personalized Care 

Children's Hospital Los Angeles Cardiologist Creates Modified Stent for 18-month-old Using Printed 3-D Model 

PolyVascular Awarded $2 Million Small Business Innovation Research Grant to Bring the First Polymer-Based Heart Valve for Children to Clinical Trials 

Bioresorbable ASD Occluder Prepares to Enter U.S. Clinical Trial 

FDA Approves Abbott's Amplatzer Piccolo Occluder 

Critical Need for Pediatric Electrophysiology Devices is Focus of Medical Device Competition  

Lab-created Heart Valves Can Grow With the Patient 

SCAI Issues Position Statement on Adult Congenital Cardiac Interventional Training, Competencies and Organizational Recommendations 

Abbott Receives European CE Mark for Two Pediatric Heart Devices 

ASE Releases Guidelines for Transesophageal Echo in Congenital Heart Disease 

Find more congenital heart disease (CHD) content 

Related Content

News | Congenital Heart

December 30, 2022 — The Smidt Heart Institute at Cedars-Sinai welcomes four new specialists to its Department of ...

Home December 30, 2022
News | Congenital Heart

November 2, 2022 — Researchers have developed a three-dimensional model that shows how exposure to cadmium might lead to ...

Home November 02, 2022
News | Congenital Heart

October 3, 2022 — A new ‘ECHO lab’ at Memorial Hospital West is benefiting patients that may have heart disease and the ...

Home October 03, 2022
News | Congenital Heart

August 2, 2022 — About one percent of the world population is born with a congenital heart defect, which affects about ...

Home August 02, 2022
News | Congenital Heart

July 6, 2022 — A team of investigators from Texas Heart Institute, Texas Children’s Hospital and Baylor College of ...

Home July 06, 2022
News | Congenital Heart

May 2, 2022 – Inside embryonic cells, specific proteins control the rate at which genetic information is transcribed ...

Home May 02, 2022
News | Congenital Heart
February 21, 2022—Nearly 1 percent of all children are born with congenital heart disease—a range of potentially life ...
Home February 21, 2022
News | Congenital Heart
February 15, 2022 – More than $625,000 in research grants devoted to congenital heart defects (CHD) were awarded today ...
Home February 15, 2022
News | Congenital Heart

December 14, 2021 – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces five awardees ...

Home December 14, 2021
Videos | Congenital Heart

Tom Jones, M.D., director, cardiac cath labs, Seattle Children’s Hospital, explains the importance of the heart team ...

Home September 15, 2021
Subscribe Now