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Laura Monti

Hiring a clinical trial associate

We are hiring a Clinical Trial Associate

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atHeart Medical is looking for a Clinical Trial Associate based in the San Francisco Bay Area (CA), to support the in-house management of our clinical trial program.

The Clinical Trial Associate is a key member of the Clinical Affairs team and is responsible to provide operational and organizational support and to track and maintain trial-related documents and materials. This is an office-based role requiring strong communication and organizational skills, ability to work independently, and to deliver in a fast-paced environment.

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 (ASDs). We want patients with ASDs to be treated with a device that keeps more transseptal 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, in Europe, and in Canada to demonstrate the safety and efficacy of our reSept ASD Occluder to treat patients with clinically significant ASD.

View full job description here

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

Health Canada approved ASCENT ASD study

Health Canada approved ASCENT ASD trial in Canada

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Health Canada approved the ASCENT ASD research study of reSept ASD Occluder in Canada. Canada is the third country to authorize the enrollment of patients with atrial septal defects (ASD) in the clinical trial ASCENT ASD, following the United States and France. To date, over 75 patients have been successfully implanted as part of this study in over 20 sites.

“We are very pleased with the positive response of the Canadian health authorities and are looking forward to supporting the new local participating sites,” said atHeart Medical CEO Laurent Grandidier. “Canadian clinicians have a successful track record in pioneering innovation in cardiovascular intervention and we are delighted that they will contribute to the scientific body of evidence of reSept’s performance in patients.”

ASCENT ASD is a prospective, single-arm study evaluating the safety and efficacy of reSept ASD Occluder, the first occluder with a metal-free, bioresorbable frame, to treat patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals of transcatheter ASD occluders currently available.

Please find further information on the ASCENT ASD trial here.

ASCENT ASD investigators meeting in USA

ASCENT ASD investigators met in Chicago (IL) for the pivotal phase

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There was much excitement at the latest ASCENT ASD Investigators’ meeting in Chicago (IL). Implanting teams from several US centers met for the first time since the trial reached its pivotal phase.

ASCENT ASD Trial Status

“For some of us early implanters, it feels like the trial is coming of age, with over 75 patients implanted across two continents,” said Thomas Forbes, MD, now Chief Pediatric Cardiac Services, Joe DiMaggio Children’s Hospital (Hollywood, FL). He performed one of the first implants at trial initiation, in his original role as Director of Cardiac Catheterization Laboratory at Children’s Hospital of Michigan (Detroit, MI). “We know the device, we work closely with the atHeart team and the other implanting sites and we are all observing the device on an ongoing basis in our patients, as part of the follow-up process.”

The ASCENT ASD trial is a US FDA and French ANSM-approved clinical study to assess the safety and efficacy of the reSept ASD occluder. reSept is the first transcatheter septal occluder with a metal-free frame. The trial is currently enrolling patients in over 20 study centers in the United States and in France.

ASCENT ASD US National PI

“A device that enables a conservative management of the septum may be the difference between requiring or avoiding open-heart surgery in someone’s life, in case for instance of heart valve repair at a later age,” said Larry Latson, MD, the US National Principal Investigator for the ASCENT ASD study and a pediatric and adult cardiologist at Joe Dimaggio Children’s Hospital (Hollywood, FL). “Even though pediatric patients may most likely have a different treating clinician in adult life, making long-term decisions early on is very important”.

An atrial septal defect is a hole in the heart wall that separates the two upper heart chambers called atria. ASDs are among the most common heart defects children may be born with. Please follow the link for further information on ASDs.

First patient from ASCENT ASD study implanted in Ohio

First Ohio patient implanted with reSept as part of the ASCENT ASD study

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The Interventional Cardiology team at Nationwide Children’s Hospital in Columbus successfully implanted the reSept ASD Occluder in the first enrolled Ohio patient as part of the ASCENT ASD study.

ASCENT ASD is a research study authorized by the US FDA to assess the safety and efficacy of the reSept ASD occluder, to treat patients with significant ASDs. reSept 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.

“Decades ago, the closure of ASDs became minimally invasive with the first transcatheter occluder. The next advancement in ASD device technology is to make these devices bioresorbable so that a metal frame is not left behind. This allows transseptal interventions to be much easier later in life, if treatment for arrhythmia is needed,” said Dr. Aimee Armstrong, Director of Cardiac Catheterization and Interventional Therapies at Nationwide Children’s Hospital and Professor of Pediatrics at The Ohio State University College of Medicine.

An atrial septal defect is a hole in the wall between the top two chambers of the heart. ASDs are among the most common heart defects in children. They can be treated with a device through a minimally invasive procedure in most patients. Please follow the link for further information on ASDs.

In the US, the ASCENT ASD Study is currently enrolling patients in over 20 centers.

75th patient implanted as part of ASCENT ASD trial at CHU Nantes in France

75th patient implanted for ASCENT ASD study

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Dr. Céline Grunenwald implanted the 75th patient of the ASCENT ASD study at Nantes University Hospital CHU. This is one of the four centers in France and over 20 centers in the United States currently enrolling patients in the reSept ASD Occluder ongoing pivotal study.

“Transcatheter interventions are minimally invasive for patients compared to open-heart surgery. They enable faster recovery and return to normality,” explained Dr. Grunenwald, pediatric cardiologist specializing in transcatheter interventions at CHU Nantes. “A transcatheter device that helps preserve the heart’s natural structure may keep other transcatheter options open for the future. This could enable a virtuous circle of less invasive treatments in the life of a young patient born with a heart defect.”

The reSept ASD occluder is the first transcatheter septal occluder with a metal-free frame for atrial septal defect closure. Designed with long-term treatment in mind, the reSept ASD Occluder’s frame is made of fabric patches connected by bioresorbable filaments. It aims to maintain a low and more natural profile in the heart, compared to devices with a metal frame.

“We are delighted to see that patient’s enrolment in the trial is progressing well on both sides of the Atlantic,” said Laurent Grandidier, atHeart Medical CEO. “Thanks to these patients, their families and their clinicians, we are able to build a growing body of evidence for an evolved way to treat atrial septal defects.”

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

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.