In tune with your patients’ needs

Every CHD patient is anatomically unique so matching them to the right treatment is key.

Harmony™ TPV offers a minimally invasive option for patients with severe pulmonary regurgitation in a native or surgically repaired right ventricular outflow tract (RVOT).

Valve and system overview

The Harmony™ transcatheter pulmonary valve is specifically designed for the native RVOT.

Fully-sheathed delivery system

This delivery system is highly trackable through the vasculature.1

This is an image of the Harmony™ transcatheter pulmonary valve (TPV) capsule delivery system.

Self-expanding nitinol frame

The Harmony™ TPV is constructed of a self-expanding nitinol frame made up of individual wire struts, designed to conform to the native RVOT anatomy.

This is an image of the Harmony™ transcatheter pulmonary valve (TPV) nitinol frame.

Porcine pericardial leaflets

Porcine pericardial leaflets provide excellent kinematics across the full range of pressures of the right heart.2,3

This is an image of the Harmony™ transcatheter pulmonary valve (TPV) leaflets.

Valve features

Harmony™ TPV 22

This is an image of the Harmony™ 22 transcatheter pulmonary valve (TPV).

Harmony™ TPV 25

This is an image of the Harmony™ 25 transcatheter pulmonary valve (TPV).
  • The valve and frame are integrated to provide a one-step delivery process, facilitating predictable device deployment in the intended position6
  • Porcine pericardial tissue valve 
  • Self-expanding nitinol frame
  • Polyester cloth covering
  • Multiple valve sizes with different inflow diameters, outflow diameters, and lengths to fit a range of patient anatomies

Harmony™ delivery catheter system

See the Harmony™ transcatheter pulmonary valve (TPV) delivery catheter system features up close.
 
  • Coil loading system facilitates simple loading of the valve
  • Loading funnel to compress valve prior to sheathing
  • Retractable sheath
  • Ergonomic handle facilitates unsheathing and release of valve for final deployment

Enhance care, amplify life

Harmony™ midterm data highlights

Harmony™ TPV sustains it's excellent safety profile4

0%

No new ventricular tachycardia following implant through three years.

N = 88

0%

No new deaths, thrombosis, or major stent fracture between the 2nd and 3rd year4.

N = 88

Demonstrates positive sustained remodeling in right ventricle4

View this graphic to see the reduction in right ventricular end-diastolic volume index at two years pre- and post-implant of the Harmony™ transcatheter pulmonary valve (TPV)

32%

reduction in right ventricular end-diastolic volume index at two years.

N = 27

Pre-implant: 151.0

Post-implant: 102.9

Harmony™ TPV sustains improvement in quality of life4

QoL scores are nearly normal at

3 years.5

Clinically similar to normal population5 in patient-reported QoL outcomes in physical functioning, energy/less fatigue, and general health.

SF-36 Harmony™ TPV subjects at 3 years

View this graph to see the quality of life of Harmony™ transcatheter pulmonary valve (TPV) subjects after three years based on scoring.

Harmony™ TPV sustains it's excellent effectiveness profile4

100%

of TPV 22 patients

N = 32

96%

of TPV 25 patients

N = 25

Patients with none/trace or mild pulmonary regurgitation at 3 years

Pulmonary regurgitation

Implanted cohort – echo core lab

TPV 22

View this bar chart to see the pulmonary regurgitation of the Harmony™ transcatheter pulmonary valve (TPV) 22.

TPV 25

View this bar chart to see the pulmonary regurgitation of the Harmony™ transcatheter pulmonary valve (TPV) 22.