Medtronic’s Harmony Pulmonary Valve Gets FDA Approval

Dive brief:

  • The FDA announced Friday that it has approved Medtronic’s catheter therapy for pediatric and adult patients with severe pulmonary valve regurgitation into the right ventricular outflow pathway, which carries blood from the heart to the lungs.
  • The Harmony transcatheter pulmonary valve offers a less invasive treatment alternative to open heart surgery for patients with the disease, which is usually the result of a congenital heart defect. The FDA has declared the Medtronic device to be the first non-surgical valve approved to treat these patients.
  • The Harmony valve received pre-market approval from the FDA after receiving the agency’s breakthrough device designation to accelerate its development. The approval was based on a clinical study of 70 patients in which all patients met the primary safety endpoint of no death within 30 days of implantation and 89.2% of patients with Echocardiography data met the primary efficacy endpoint of any additional device-related procedures more acceptable. blood circulation at six months.

Dive overview:

Medtronic and Edwards Lifesciences are the dominant players in the constantly growing catheter aortic valve replacement, or TAVR market, which overtook surgery in the United States in 2019 as the primary approach for the treatment of defective aortic valves. Corporate efforts to develop minimally invasive treatments to rival Abbott’s lead in mitral valve space are also being watched closely.

New approaches to treating pulmonary valve disease have received less attention, but Medtronic has been working in this area for more than a decade, starting with the development of its Melody catheter valve replacement, which is approved for patients with Dysfunctional right ventricular outflow duct. . The Harmony device is a self-expanding transcatheter valve, while the Melody is a balloon expandable valve.

Edwards is also considering the pulmonary valve market and last year obtained FDA approval for an expanded indication of its Sapien 3 transcatheter heart valve for use in patients with a dysfunctional right ventricular outflow duct or bioprosthetic valve. dysfunctional in pulmonary position.

Open heart surgery is the current standard of care for improving blood flow to the lungs in patients with pulmonary valve regurgitation, in which blood flows back to the heart. A patient with congenital heart disease may face several open heart surgeries to resolve pulmonary valve problems. The FDA has said that using Medtronic’s Harmony valve could help patients delay or reduce the number of repeat open heart surgeries needed over a lifetime to treat the disease.

“It offers a less invasive treatment alternative to open heart surgery for patients with a leak from a native or surgically repaired RVOT and can help patients improve their quality of life and return to normal activities more quickly, responding thus to an unmet clinical need for many patients with congenital heart disease, ”said Bram Zuckerman, director of the cardiovascular disease office of the FDA, in a statement.

The Harmony device is implanted through a catheter into a vein in the groin or neck. The collapsed valve is released in the right ventricular outflow pathway, where it expands on its own. The FDA said the follow-up period for observing patients who received the Medtronic Harmony valve was extended from five years to 10 years as part of the post-approval study.

Like other major medical device makers, Medtronic had to contend with another procedural slowdown that hit late last year and continued into the new year, following the initial setback related to the pandemic and the subsequent rebound in pent-up demand. CEO Geoff Martha predicted a return to growth last month, but did not provide a near-term financial outlook.


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Harmony pulmonary valve gets FDA green light

Medtronic’s Harmony Transcatheter Pulmonary Valve (TPV) was approved Friday for the treatment of severe pulmonary regurgitation with a native or surgically repaired right ventricular outflow (RVOT) port.

This clears the implantation of TPV, a less invasive alternative to open heart surgery, for people who have had RVOT surgery for congenital heart defects (CHD) but have not received an anterior valve duct or right ventricle-pulmonary artery (RV-PA).

Putting on Harmony can delay the time before a patient needs additional open heart surgery and reduce the total number of surgeries needed in a person’s lifetime.

Harmony “can help patients improve their quality of life and return to normal activities more quickly, thereby addressing an unmet clinical need in many patients with congenital heart disease,” said Bram Zuckerman, MD of the FDA, in a press release.

Melody, a TPV also different from Medtronic, has been on the market since 2010 and is indicated for implantation into a dysfunctional RV-PA conduit or bioprosthetic pulmonary valve.

The FDA approved Harmony after looking at data from 70 people in a single-arm study, the preliminary results of which were released last year.

The study met its primary safety endpoint as there were no procedural or device-related deaths within 30 days of valve placement. The primary endpoint of effectiveness was also met, with 89.2% of people with evaluable echocardiography requiring no additional device-related procedures and acceptable cardiac blood flow function at 6 months.

Adverse events reported included arrhythmias (23.9%), leakage around the valve (8.5%), minor bleeding (7.0%), pulmonary valve narrowing (4.2%) and movement of the implant (4.2%).

Harmony’s labeling indicates that it is contraindicated for infected patients, people who cannot tolerate anticoagulant drugs and those who are sensitive to nitinol (titanium or nickel).

  • Nicole Lou is a reporter for MedPage Today, where she covers current events in cardiology and other developments in medicine. To follow



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Collector time | Harmony Innovation Shipping liquidators call creditors’ meeting


A notice was published in the Official Journal on Monday March 22 regarding the liquidation of Harmony Innovation Shipping Pte Ltd.

According to the notice, a meeting of creditors will be held via Zoom on Wednesday March 31, 2021 at 11:00 a.m. for the following purposes:

  1. The Liquidator initiates and explores settlement negotiations with the Respondent and / or their attorneys regarding an arbitration proceeding under the London Maritime Arbitrators’ Association which is ongoing between the Company and the Respondent in London; and
  2. Consider any other matter which may be regularly submitted to the meeting and which is relevant to the liquidation of the Company.

Creditors can attend the above meeting by submitting a general or special proxy form and include participant details by email by 11:00 a.m. on Tuesday, March 30, 2021.

Further details of the videoconference will be released shortly after receipt of the above details and confirmation, provided the details and confirmation are provided in a satisfactory form.

To entitle creditors to vote at the meeting, they are required to file their proof of debt by mail at the liquidator’s office or by email.

The published contact details of the Liquidator are as follows:

M / s Mann & Associés PAC
3 way Shenton,
# 03-06C Shenton House
Singapore 068805

[email protected]
[email protected]


Posted: 23 March 2021


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Students find harmony in music during pandemic

By Anel Ceballos-Caldera, March 23, 2021

Balancing work, school, and the stress of the pandemic, students at Cal Poly Pomona have become more sensitive to music as a form of therapy.

This March, many forms of entertainment – including campus events, theme parks and cinemas – temporarily closed and unexpectedly turned the lives of students upside down. These limitations have allowed many Broncos to not only use music as a form of entertainment, but also find solace in releasing stress and upping their spirits.

Living through a global pandemic with social distancing regulations and more than 500,000 American lives lost to COVID-19, life has been difficult. For Justin Mo, a sophomore hotel management student, music helps brighten up his days.

“The pandemic is not a plus, so I try to listen to more upbeat and more pop stuff to cheer myself up,” Mo said. “Music is important to me because it brings people together and can help someone mentally and emotionally. It speaks to many listeners because of the depth to which the lyrics are written.

Like Mo, first-year business student Thomas Phan said music has been essential to weathering the pandemic.

“The pandemic has been a really strange time, so I’m listening to more heartwarming and upbeat music just to lighten the mood,” Phan said. “Music has helped me a lot. When I feel stressed, it calms me down. When I feel sad, it lifts me up. No matter what feeling I have, there’s always a song for it. It’s like medicine honestly.

Through emotional lyrics or cheerful rhythms, students are able to identify and resonate with the feelings expressed in the songs, which reflect what they are feeling while socially distancing themselves at home.

According to American Psychological Association, Psychologist Daniel Levitin and researcher Mona Lisa Chanda found that music improved the body’s immune system function and reduced stress through meta-analysis of 400 studies in 2013.

Music therapy is a health profession that responds to physical, emotional, cognitive and social needs by producing, singing or listening to songs, depending on the American Association for Music Therapy.

“Music influences health,” Levitin told the American Psychological Association. “Researchers have found that listening to and playing music increases the body’s production of immunoglobulin A and natural killer cells, cells that attack invading viruses and boost the efficiency of the immune system. Music also lowers the levels of the stress hormone cortisol.

During the pandemic, Spotify, the world’s leading music streaming service, increased the number of monthly active users to around 345 million users at the end of last year, a 27% jump from the previous year. ‘previous year, according to Spotify Investors. With its positive association with mental and emotional health, more and more people are looking for music through various streaming platforms.

Streaming songs can also prevent students from feeling lonely in a socially remote world. Melody Bando, fourth year graphic design student, highlighted the impact of music in her daily life, describing its role as a “coping mechanism to help pass time or to fill in background noise”.

“The music is so versatile,” Bando said. “There is music you can listen to to match that moment or that mood. It’s probably a good balance for me. In a chaotic schedule, I can be soothed with the right music or get pumped when I’m feeling down. Music helps any situation and is just another language.


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