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atHeart Medical hiring Head of Therapy Development in USA

Head of Therapy Development – US Opening

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atHeart Medical is hiring an experienced and highly collaborative Head of Therapy Development in the USA. The Head of Therapy Development will drive stakeholders’ engagement and market readiness throughout the US pivotal clinical trial program and beyond.

This role will be key in the atHeart Medical matrix, connecting with Clinical Affairs and R&D, and driving marketing activities to support the reSept ASD Occluder’s value proposition.

The Head of Therapy Development is US-based, can work remotely and spends significant time travelling. For a full job description, please view our job opening on Lifeblood.  For any further questions regarding this position, please contact Marina Lohri.

atHeart Medical was founded to establish the first transcatheter septal occluder with a metal-free frame, as the new standard of care for atrial septal defects (ASD). We want patients with ASDs to be treated with a device that keeps more transeptal treatment options open for their future. Our name embeds our values: in everything we do, we have clinical excellence and patients at heart.

We are conducting the US FDA-approved ASCENT ASD pivotal trial in the USA and in Europe. The trial investigates the safety and efficacy of our reSept ASD Occluder to treat patients with clinically significant, isolated ASD.

First hospital in Georgia started implanting patients as part of the ASCENT ASD study

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Children’s Healthcare of Atlanta (CHOA) is the first hospital in Georgia to implant the reSept ASD Occluder in patients with atrial septal defects (ASD) as part of the ASCENT ASD study.

Interventional cardiologist Dr. Dennis Kim led the team that conducted the intervention to successfully seal a child’s ASD for the first time in Georgia. Dr. Kim is Director of the Pediatric Cardiac Catheterization Labs at CHOA Heart Center. He specializes in interventional procedures and minimally invasive treatments for congenital heart disease and is involved in a variety of clinical trials for new transcatheter device therapies, including ASCENT ASD. ASCENT ASD is an FDA-approved research study currently enrolling patients in over 20 centers across 18 States in the USA.

“Our team is excited to contribute to research that may advance the treatment for ASDs by leaving a minimal footprint in a child’s heart,” said Dr Kim. “The reSept device is a game changer due to its bioresorbable properties and represents true innovation in implantable cardiac device therapy.

atHeart Medical’s reSept ASD Occluder is the first transcatheter septal occluder with a metal-free frame. Occluders currently available have a metal frame that remains in the patient’s heart for life.

“We are grateful to Dr. Kim and to the extraordinary clinicians that have joined ASCENT ASD, for their commitment to improve ASD treatment, and to patients and their parents for their trust in research,” said atHeart Medical CEO Laurent Grandidier. “Our device has been developed with a life’s journey in mind, with a heart that has less metal and a more natural septum profile.”

An atrial septal defect is a hole in the heart wall called septum that separates two heart chambers. ASDs are among the most common heart defects children may be born with. They can be treated with an occluder through minimally invasive surgery in most patients. Please follow the link for further information on ASDs.

First reSept ASD Occluder implanted in Nantes

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The reSept ASD Occluder has been implanted in the first patient in Nantes, as part of the ASCENT ASD trial. Nantes University Hospital CHU is one of the few centers in France currently taking part in the ASCENT ASD trial in Europe.

The intervention was conducted by the team led by Professor Alban Baruteau, Head of the Pediatric and Congenital Cardiology Medical-Surgical Department at CHU Nantes.

“Assessing a novel technology that may improve current and future treatment for patients with congenital heart conditions, like atrial septal defects, is important for the progression of clinical research and healthcare,” said Professor Baruteau. “We are pleased to be able to offer this option to patients in the Nantes area, as part of this clinical study.”

The ASCENT ASD trial is a French ANSM and US FDA-approved clinical study to assess the safety and efficacy of the reSept ASD occluder, the first transcatheter septal occluder with a metal-free frame. The trial is currently enrolling patients in four centers in France, including Bordeaux, Nantes, Paris and Toulouse and in several study centers in the United States.

“The ongoing enrollment of patients in France and in the USA is very promising in the journey to bring a solution for atrial septal defects that may leave less metal behind,” said Laurent Grandidier, atHeart Medical CEO. “We are delighted to add CHU Nantes to the list of prestigious hospitals participating in the ASCENT trial”.

Please follow the links for further information on the ASCENT ASD study and on ASDs.

7-14 February is CHD Week

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We are marking Congenital Heart Disease Week 7-14 February this year thinking of the difficult times parents of children born with congenital heart defects have to face and the hard decisions they have to make. “Why treatment, what treatment, when, where, what risks, which symptoms…?” the questions are nearly endless.

All they do is out of love for little hearts that cannot work as well as others and therefore deserve more attention, more support and more care.

Atrial Septal Defects (ASDs) are one of most common congenital heart defects. They can be treated with minimally invasive surgery. We are working day in day out to make ASD closure even less invasive, to leave more options for the patients’ future.

To learn more about ASDs check out Mended Hearts ASD page, video and discussion guide.

atHeart Medical is looking for a Clinical Specialist

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atHeart Medical is looking for a dynamic and engaging Clinical Specialist based in the Midwest, Texas or on the West Coast to help drive progression of our US pivotal clinical trial program.

The Clinical Specialist is a crucial member of the Clinical Affairs team and is responsible to provide technical guidance at product and study level, working closely with other departments.

atHeart Medical was founded to establish the first transcatheter septal occluder with a metal-free frame, as the new standard of care for atrial septal defects (ASD). We want patients with ASDs to be treated with a device that keeps more transeptal treatment options open for their future. Our name embeds our values: in everything we do, we have clinical excellence and patients at heart.

We are conducting the US FDA-approved ASCENT ASD pivotal trial in the USA and in Europe, to demonstrate the safety and efficacy of our reSept ASD Occluder to treat patients with clinically significant, isolated ASD.

View full job description

For further information or to apply, please contact careers@atheartmedical.com

Mended Hearts groups launch ASD awareness campaign with atHeart Medical

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US patient support groups Mended Hearts and Mended Little Hearts launched an awareness campaign on atrial septal defects (ASDs) thanks to an unrestricted educational grant by atHeart Medical.

The campaign provides patients and families of children with ASDs with information on symptoms and treatment options, including a downloadable discussion guide to prepare for health visits and an educational video featuring interventional cardiologist Scott Lim, MD, from University of Virginia.

“Like most congenital heart defects, ASDs deeply affect the lives of those born with them. We work to inspire hope and improve the quality of life of heart patients and their families through ongoing support, education and advocacy,” said Denise Duch Widzgowski, Mended Hearts President. “We are grateful to partners like atHeart Medical for enabling us to pursue our mission.”

ASDs are a congenital heart defect (CHD) and make up for 5 to 10 percent of all heart problems babies can be born with. It is important to treat an ASD as early as possible to prevent heart failure, stroke, lung problems, valve problems, and arrhythmias. Treatment will depend on the ASD size, the severity of symptoms and patient’s age.

“As a young company, we are incredibly proud to support the fabulous work that the Mended Hearts group conducts for patients in the USA, nationwide and chapter by chapter. Information, education and support can make the difference in patients’ lives and choices,’ said atHeart Medical CEO Laurent Grandidier.

View the ASD awareness information and materials on Mended Hearts website

ASCENT ASD trial started Stage 3 enrollment, following US and EU regulatory authorization

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The ASCENT ASD pivotal trial of atHeart Medical’s reSept ASD occluder has advanced to Stage 3 enrollment, following regulatory authorization of trial expansion by the US Food and Drug Administration (FDA) and by the French National Agency for Medicines and Health Products Safety (ANSM).

The positive decisions of the regulatory authorities followed the review of data from the first 50 US and EU patients, as part of the initial stages of this ongoing trial.

“Our team is delighted to progress with patient enrollment following the green light from the FDA and ANSM. We are committed to demonstrate that ASDs may be effectively closed without jeopardizing cardiovascular treatments that patients may need in the future,” said CEO Laurent Grandidier.

ASCENT ASD is a prospective, single-arm study evaluating the safety and efficacy of the reSept™ ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for the treatment of patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD occluders. The trial is aiming to enroll a total of up to 250 patients.

View which US and EU hospital sites are actively recruiting patients in the ASCENT ASD trial here

Meet our new VP R&D NextGen

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Vice-President Fabien Lombardi recently joined atHeart Medical to lead the R&D team driving forward next generation devices. He boasts a comprehensive background in project management, spanning across various facets from materials to the development of products.

“We are thrilled to benefit from Fabien’s forward-thinking mindset and strategic technical planning,” said atHeart Medical’s CEO Laurent Grandidier. “His successful track record of 20+ years in medical device development and leadership is a great asset for the evolution of atHeart Medical’s future devices.”

Prior to atHeart Medical, Fabien held leadership roles at startups in structural heart devices and biomaterials and at well established companies across multiple European countries, Australia and the United States.

“I am thrilled to be part of atHeart Medical’s extraordinary team and of a very ambitious program to ultimately improve the life of people with structural heart issues,” Fabien said.

View all team’s bios here

Children’s Heart Awareness Day

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On 5th of May, it is Children’s Heart Awareness Day in Switzerland. As a Swiss/American company, we want to mark this day to remember when most heart journeys begin: during infancy and childhood.

In Switzerland, a child is born with a heart defect every hundred births.  Although some heart defects resolve over time, more severe ones may require interventions, in childhood and later in life.

We are very mindful of our purpose, to help find better solutions for children and adults born with atrial septal defects. With our work, we endeavour to ease their heart journey, to help reduce the need for interventions and to keep more treatment options open for their future.

1200 gloves for a hospital in Ivory Coast

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The Dabou Hospital in Ivory Coast is currently using 1200 new, sterile medical gloves donated by atHeart Medical. It is thanks to the long-standing work done by the Ruedi Leuppi Foundation, a Zug-based charity working in Ivory Coast, and the relentless problem-solving approach of our VP of Operations, Alex Goehring, that we managed to ship in no time a significant supply of gloves where they would be mostly needed.

Swiss clinician Dr Leuppi has been cooperating with the Dabou Methodist Hospital since 2004. He established the first urology department onsite and is spending several weeks on multiple trips each year to provide materials and donations, and to train local healthcare professionals.

“We are happy to accept material (medicine, laboratory, training) as long as it is still in good condition. Even used material from Switzerland here in Dabou is indispensable work material to serve patients,” Dr Lueppi explained.

“Two days after establishing contact, Dr Leuppi came to collect the equipment, which few days later was already in a container on its way to Africa,” said Alex. “It was a fantastic team effort to preserve valuable medical equipment, which needed replacement due to changes in our production process, and to put it to good use to treat human lives.”

To learn more or to donate to the Leuppi Foundation, please click here