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Product Profile

Harmony Transcatheter severe, such as tiredness, shortness of breath, fatigue,
dizziness or weakness while performing normal activities.
Pulmonic Valve (TPV) For CHD patients born with pulmonary artery/valve
abnormalities who undergo a surgical repair early in life, the
Harmony TPV is designed to provide a less invasive option to
GIVING KIDS A BRIGHTER FUTURE restore normal valve function later in life. Currently, the only
approved option in the world for these patients is an open
It was early 2007 when a request was made to Medtronic by a heart surgical valve replacement.
London based cardiologist to bring a self expanding pulmonic
valve design, which he had conceptualized, to life. A patient of Harmony TPV
his was desperately ill and had run out of treatment options Simon’s procedure was a great success leading to a first-of-
for his failing pulmonic valve. This pioneering treatment could its-kind early feasibility study (EFS) initiation by Medtronic
be his last chance at a normal life. Following many months in close collaboration with the FDA in an effort to develop
of collaboration between various engineers across the a minimally invasive alternative to open-heart surgery for
corporation and medical world, the valve was manufactured patients with Congenital Heart Disease (CHD). 20 patients
and personally delivered by Medtronic staff to the hospital were implanted, with the average age of the enrolled cohort
ready for implantation. being 25 years and the youngest patient being just 14 years
old. Positive 24 month follow up data was presented at

When the patient, a young man named Simon, received the Transcatheter Cardiovascular Therapeutics – TCT in Oct 2015
first Medtronic Harmony valve in a humanitarian capacity in which led the FDA to advise Medtronic to expand the clinical
January 2009, it was a First-in-Human medical milestone for data set through a Pivotal clinical study which commenced
transcatheter, self-expanding pulmonic valves and the start in the US in late 2016. The Pivotal clinical study is currently
of Medtronic’s journey in developing a minimally invasive ongoing and being supported by a number of individuals across
option to restore normal pulmonic valve function. the globe. Lisa DeStefano, QA at the Danvers, Massachusetts
site, has been involved in the project since 2007 where that
Congenital heart disease (CHD) is the most common type
of birth defect in the United States, affecting an estimated first device was qualified and built for Simon back in late 2008.
40,000 infants each year. There are many different types of The overall quality core team lead for the Harmony is Chau
CHD, including abnormalities in the structure of the heart and Tran who works from the Santa Ana site at MOC. In Galway,
pulmonary artery/valve. After surgical correction of these Karen Collins is the QA lead for the commercial Delivery
defects, such as those that occur in Tetralogy of Fallot, a System with Regina Gorham being the QA operations team
serious CHD where four defects are present simultaneously, member for the commercial Delivery System. The team have
the pulmonary valve is altered or removed, resulting in severe plans to bring a an additional sized valve to the pivotal clinical
leakiness of the valve. Severe pulmonary valve regurgitation trial in Spring 2018 so that even more patients can be treated
symptoms may occur, ranging from mild to with this promising and exciting new transcatheter valve
therapy.

(From left to right)
Karen Collins (QA Delivery System) Galway)
Lisa DeStefano (QA Delivery System) Danvers
Regina Gorham (QA Operations Delivery Systems) Galway
Chau Tran (QA Core Team Member) Santa Ana