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Chris Wiley VP for Field Operations and Therapy Development atHeart Medical

Chris Wiley is our new VP for Field Operations and Therapy Development

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Chris Wiley joined the atHeart Medical team as Vice-President for Field Operations and Therapy Development. He leads the American and European roll-out of our clinical trial program.

Chris has 20 years of field operations’ experience in structural heart devices from major corporations. He masters the complexities of multi-center clinical trial execution across geographies, understanding clinicians’ needs and delivering clinical support. He also trained as a radiologic technologist in the United States Air Force, where he specialized in cardiovascular interventions.

“Chris’ expertise in septal defects closure and his reputation among the medical community are phenomenal assets for our field operations,” said atHeart Medical’s CEO Laurent Grandidier. “We are very pleased to have him in a leading role for the seamless execution of our clinical trial program, as more patients requiring ASD closure are joining the ASCENT ASD trial.”

ASCENT ASD is a global multi-site clinical trial approved by US FDA, French ANSM, Health Canada and Swissmedic enrolling up to 250 patients in over 20 centers across two continents.

“atHeart Medical has the ambitious goal of improving the standards of care in atrial septal defects closure. I am very pleased to share my knowledge and expertise to serve this purpose,” said Chris.

View all team’s bios here

Dr. Goldstein and the UPMC team

UPMC implanted their first patient for ASCENT ASD – the second enrolling center in Pennsylvania

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The University of Pittsburgh Medical Center (UPMC) Children’s Hospital of Pittsburgh implanted their first patient with a reSept ASD Occluder. They are the second enrolling center in Pennsylvania participating in the ASCENT ASD study.

The patient had a congenital atrial septal defect (ASD), a hole between the upper chambers of the heart, that required closing. Bryan Goldstein, MD, Professor of Pediatrics and Director of Cardiac Catheterization and Intervention at UPMC Children’s successfully conducted the minimally invasive cardiac intervention with his team, implanting reSept as part of the trial.

“I see a future for a hybrid device for ASD closure that has less metal and a resorbable frame, potentially offering a long-term perspective to treatment, particularly to future transseptal interventions,” said Dr. Goldstein. “The 10-year efficacy data from previous studies on this device, recently presented, are a promising platform for further research. I am pleased to contribute to it in Pittsburgh, offering an investigational option to suitable patients.”

The ASCENT ASD Study

In addition to UPMC, the reSept ASD Occluder is being implanted in Pennsylvania at Children’s Hospital of Philadelphia, and in over 20 other centers in the USA, Canada, France and Switzerland, as part of the ASCENT ASD research study.

Atrial Septal Defects

An atrial septal defect is a hole in the wall called septum that separates the heart upper chambers called atria and that generally doesn’t close properly at birth. ASDs are among the most common congenital heart defects in children.

Most patients can be treated with an ASD occluder through a minimally invasive transcatheter procedure. Currently available occluders have a metal frame that stays in a patient’s heart for life. reSept is the first ASD occluder with a bioresorbable, metal-free frame currently in pivotal phase in the ASCENT ASD study

Please find further information on ASDs here.

atHeart Medical is hiring a Clinical Specialist

atHeart Medical is looking for a Clinical Specialist

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atHeart Medical is looking for a dynamic and engaging Clinical Specialist based near a major US airport (Charlotte, Atlanta, Detroit, Minnesota, Chicago, Denver) to help drive progression of our US pivotal clinical trial program.

The Clinical Specialist is a crucial member of the Clinical Field Operations team and is responsible for providing 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 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 and in Europe, to demonstrate the safety and efficacy of our reSept ASD Occluder to treat patients with clinically significant ASD.

View full job description

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

The reSept ASD occluder has a metal-free frame

Promising long and short-term clinical data show reSept potential

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Promising long and short-term clinical outcomes of reSept ASD occluder will be presented at the medical conference CSI Frankfurt on Wednesday 19th June. The data from three patient cohorts show positive efficacy and safety profile that contribute to a growing body of evidence about the innovative device’s potential. reSept is the first ASD occluder with a bioresorbable, metal-free frame, designed to enable future transseptal treatment: a true evolution for patients that need transcatheter septal closure.

A growing body of evidence

The new reSept data to feature at CSI include:

  • Positive ten-year outcomes from the first-in-human (FIH) trial showing long-term efficacy and safety of the device – to be presented by Dr. Kolja Sievert, from the CardioVascular Center Frankfurt (DE)
  • Promising two-year data showing complete closure in a case study from the University of Virginia (UVA) cohort of ASCENT ASD, the ongoing pivotal trial approved in the USA, Canada, France and Switzerland – discussed by Dr. Scott Lim, Professor of Medicine and Pediatrics at UVA
  • One-month reSept efficacy in patients with iatrogenic ASDs (iASDs), caused by mitral valve intervention, from the Canadian first-ever experience through Health Canada’s Medical Devices Special Access Program – shown by Dr. Fady Zaky from St Paul’s Hospital, Vancouver, (CA)

“Having pioneered reSept in its early days as part of ASCENT ASD in the USA, I am very pleased about the long-term outcomes from the earlier European FIH trial and the wealth of promising new data available,” said Dr. Saibal Kar, National Physician Director HCA Healthcare, USA, co-Principal Investigator of the ASCENT ASD trial. “They indicate how transcatheter ASD closure with a bioresorbable device could become an even less invasive procedure for patients long-term. This is a very exciting development for our patients.”

To date around 100 patients with ASDs have been successfully treated as part of trials and special access iASD adult use in Canada, France, Germany, Switzerland and the USA. The ASCENT ASD pivotal study is currently enrolling patients in over 20 hospitals in the United States, four hospitals in France and will start treating patients in Canada and in Switzerland following Health Canada and Swissmedic’s recent authorizations.

“Around 100 patients have been implanted with reSept to date. While hospitals continue to enroll patients as part of ASCENT ASD in several countries, we are excited that these positive outcomes showcase the potential for reSept to soon be the new standard of care,” said Laurent Grandidier, atHeart Medical CEO.

The reSept ASD Occluder is an investigational device that aims to address the limitations of current occluders, which have metallic frames that stay in a patient’s heart for life and can limit transseptal interventions.

Please see full release here.

Please find further information on ASDs here.

Swissmedic approved the ASCENT ASD research study of reSept ASD Occluder in Switzerland.

Swissmedic approved the ASCENT ASD trial

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Swissmedic approved the ASCENT ASD trial of reSept ASD Occluder in Switzerland. Following the authorization from the Swiss health authorities, the research study will soon begin to enroll patients with atrial septal defects (ASDs) in selected hospitals in the country.

“With our European headquarter in Switzerland, it is particularly important for us to receive the green light for our research by the Swiss authorities,” said atHeart Medical CEO Laurent Grandidier. “We work to improve the standard of care in atrial septal closure, and we are pleased to be able to do it in our closest community.”

In addition to Switzerland, the trial has recently received approval in Canada, and has enrolled over 80 patients so far in France and in the United States across more than 20 sites.

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 ASDs here.

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.