CHD patient

The ASCENT ASD study had a successful start in Lille, with three interventions in a day at Lille University Hospital – CHU Lille. It is the fifth hospital in France currently treating patients with atrial septal defects (ASDs) with the reSept ASD Occluder, as part of this ongoing study.

“We found the intervention straightforward and were able to perform three successful cases on our first approach with the device, also thanks to new imaging technology to position it,” said Dr. Ali Houeijeh, who led the implanting team at CHU Lille. “Closing an atrial septal defect with less metal and leaving a more levelled and potentially re-crossable septum seems a desirable evolution for ASD closure.”

reSept ASD Occluder

The reSept ASD Occluder can close an atrial septal defect with a minimally invasive procedure, like currently available ASD occluders. From a small incision in the groin, the device reaches the patient’s heart through a catheter. Once in position on each side of the ASD, the reSept fabric disks pull together to close it.

Unlike existing ASD devices, the reSept ASD Occluder doesn’t have metal in its frame. Its structure is made of two fabric disks connected by bioresorbable synthetic filaments. Once the disks become part of the repaired septum, covered by patient’s tissue, the filaments dissolve in the body. As they are bioresorbable, they turn into water and CO2, to be naturally expelled and exhaled over the course of two years.

Therefore, with no frame left and less metal overall, the repaired septum has less of a bulging profile compared to existing metal devices. Moreover, it may be easier to cross it for future surgical intervention, if needed.

The ASCENT ASD study

Today, over 100 patients live with a reSept ASD occluder in their hearts. In addition, more than 20 hospitals in North America and in Europe are currently offering it as a treatment option for ASD closure, as part of the ongoing ASCENT ASD study.

“It is very rewarding to see our technology in clinicians’ hands to positively change patients’ lives,” said Laurent Grandidier, atHeart Medical CEO. “From day one, we focused on developing a solution that can address critical healthcare needs with reliable quality. The progress is very promising.”

We are thrilled to welcome on board Beji George as atHeart Medical’s Senior Director for Global Field Operations and Therapy Development. He will lead the American and European efforts for physician engagement and patient enrollment, as part of our clinical trial program.

Cardiac medical device expertise

Beji is an all-round expert in cardiac medical devices. He joins us from Abbott Laboratories Cardiac Rhythm Management business, where he supported the launch of a groundbreaking leadless pacemaker.

His proven track record combines extensive experience at major corporations like Abbott, Boston Scientific and Medtronic and at growing start-up companies like EBR Systems. Overall, he worked for 25 years in sales and clinical management, field operations and therapy development in the USA and worldwide.

“We are delighted to have on board such a recognized driven leader for our field team,” said Laurent Grandidier, atHeart Medical CEO. “Beji has a remarkable ability to cultivate strong business relationships with partnering healthcare centers. This will support the ongoing dialogue with the clinical teams participating in the ASCENT ASD study at a pivotal time.”

The ASCENT ASD study

ASCENT ASD is a global multi-site research study approved by US FDA, French ANSM, Health Canada and Swissmedic. The study will enroll up to 250 patients in over 20 centers across two continents. To date, over 100 patients have been successfully implanted as part ASCENT ASD.

“I am excited to join atHeart Medical and to share our mission to innovate atrial septal defect closure with our clinical partners,” said Beji. “These collaborations are critical for innovations to meet rigorous standards and to ultimately provide real-world solutions for patients that need them.”

Beji graduated in Kinesiology from University of Houston, Houston, Texas. Besides holding a Radiologic Sciences license from the American Registry of Radiologic Technologies, he is a former professional touring drummer (!).

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Over 25 patients have joined the ASCENT ASD study in the Midwest to date. They have received a reSept ASD occluder for their atrial septal defect (ASD) closure. This results from the joint effort of a significant group of hospitals enrolling patients in the study in this region.

Patients with an ASD that needs closing may contact one of the seven Midwestern centers, to learn if they may be able to participate in the ASCENT ASD study. The enrolling centers include Advocate Children’s Hospital (Oak Lawn, IL), Riley Hospital for Children (Indianapolis, IN), University of Michigan (Ann Arbour, MI), Children’s Hospital of Michigan (Detroit, MI), Washington University School of Medicine (Saint Louis, MO), Cincinnati Children’s Hospital (Cincinnati, OH) and Nationwide Children’s Hospital (Columbus, OH). Contact details of the enrolling centers are available here.

“On Thanksgiving week, we are grateful to the incessant work of the clinicians and study coordinators participating in the ASCENT ASD study,” said atHeart Medical CEO, Laurent Grandidier. “They are enabling patients that need ASD closure in the Midwest and in all US regions to access a new, technological evolution for their treatment.”

reSept ASD Occluder

Unlike existing ASD devices, the reSept ASD Occluder has a metal-free frame. Its structure includes two fabric disks connected by resorbable synthetic filaments. As the filaments hold the disks closely together, tissue covers and embeds the disks in the repaired septum. When no longer needed, the filaments dissolve in the body. They turn into water and CO2 to be expelled and exhaled within two years.

Today, reSept has been implanted in over 100 patients. The first procedures date back more than 10 years. 

The ASCENT ASD study

The ASCENT ASD study is assessing how safe and effective the reSept ASD Occluder is for closing atrial septal defects. reSept is the first ASD occluder with a metal-free, resorbable frame.

“We are partnering with enrolling centers in many different areas to help reduce the logistical barriers for families of patients that decide to participate in the study,” said Brandi Sadowski, atHeart Medical’s Vice President for Clinical Affairs and Regulatory. “We are grateful to the patients that have come forward to join this innovative effort for ASD treatment across the USA and Europe so far.”

An atrial septal defect is a hole in the wall between the two top chambers of the heart. ASDs are among the most common heart defects in children. Most patients can be treated with an ASD occluder through a minimally invasive procedure. However, currently available occluders have a metal frame that stays in a patient’s heart for life.

atHeart Medical celebrates one of its veteran engineers who has been working on the reSept ASD Occluder since the very early days.

The development of the reSept ASD Occluder started over 15 years ago with a small team of dedicated medical device engineers. Over time, the team significantly expanded with many more talents and competencies to turn a concept into reality. Today, over 100 patients have been implanted with reSept, with the earliest implanted patients being more than 10 years ago.

“We are proud to celebrate such a significant milestone in our journey – 15 years of team dedication and progress on our reSept ASD Occluder”, said Laurent Grandidier, atHeart Medical CEO. “Bringing such innovation to patients requires time, talent and grit. This celebration is a fantastic testimony to atHeart’s unwavering commitment to bringing a novel solution to congenital heart defect patients globally.

The ASCENT ASD study is currently enrolling patients in the USA, France, Switzerland and Canada. For more information about ASCENT ASD and the implanting centers please click here.

Unlike existing ASD occluders, the reSept ASD Occluder has a metal-free frame. Its structure consists of two fabric disks connected by naturally resorbable synthetic filaments. The filaments hold the disks closely together until tissue covers and firmly embeds the disks in the new, repaired septum. When no longer needed, the filaments dissolve in the body. They turn into water and CO2 to be naturally expelled and exhaled within two years.

Please follow the links for further information on ASDs and on the reSept ASD Occluder.

The first patient of the ASCENT ASD study has been successfully implanted in Switzerland. Professor Oliver Kretschmar performed the atrial septal defect (ASD) closure with a reSept ASD Occluder at Kinderspital, University Children’s Hospital in Zurich, a world’s leading pediatric center.

Switzerland is the second European country where the reSept ASD Occluder is available to patients with atrial septal defects (ASD), as part of the ASCENT ASD study. To date over 100 patients have had their ASD closed with a reSept device as part of the study. In addition to Switzerland, the ASCENT ASD study is being conducted in the USA, in France and in Canada. For more information on ASCENT ASD and the enrolling centers please click here.

“This study may show that minimally invasive treatment of ASD patients may be possible with a device that may help preserve the natural structure of their septal wall,” explained professor Kretschmar. “I am glad to contribute to the development of Swiss innovation in Zurich for my patients.”

The reSept ASD Occluder

Unlike existing devices that have a bulkier metal frame, the reSept ASD occluder is designed to conform with the septal wall. Its two fabric disks get embedded in the septum by heart tissue, once implanted. Its synthetic filaments naturally resorb within two years, once no longer needed.

“Our device’s structure has been designed to better respect the natural anatomy of the heart wall,” said CEO Laurent Grandidier. “It was conceived in Switzerland from the collaboration of a visionary cardiologist and Swiss engineers. We are very proud to bring it also to Swiss patients as part of this study”.

Please follow the links for further information on ASDs and on the reSept ASD Occluder.

Our very own Marina Lohri shared her inspiring story as a congenital heart defect (CHD) patient on the US podcast Heart to Heart with Anna. Marina is a true trailblazer. She was one of the first, and now one of the oldest, patients treated with a Fontan procedure for her tricuspid atresia and ventricular and atrial septal defects (VSD and ASD) in Switzerland.

Having always been open about her condition, Marina spoke with host and CHD advocate Anna Marie Jaworski about how she went from very young CHD survivor to CHD community advocate and atHeart Medical’s Executive Assistant and now Office Manager, when in search of a job with a deeper sense of purpose.

Living with CHD

Navigating the complexities of heart conditions connected to CHDs is not always easy. Nor it is being told that these come with age at 20. Marina shared how CHDs bring along their very own profound dilemmas. How they make you debate over heart treatments or pregnancy, and over different perspectives of healthcare professionals.

“Living with CHD helped me look at the positive side of life to keep going and also accept things that I cannot change,” Marina explained. “I have always been open about my struggles. Indulging in a little self-pity is normal but then you’ve got to trust yourself and get going.”

Marina’s story is testament to the pioneering clinicians that had the expertise to perform her still fairly novel surgery procedure at that time in Zurich. Her career journey brought her to align work with personal values and health needs.

“We are glad to be a supportive environment that truly understands the challenges of living with CHD,” said CEO Laurent Grandidier. We also very much appreciate Marina’s personal perspective.”

Marina’s passion and positive energy are daily boosters for the whole atHeart team, for which we are all very grateful.

Listen to the full podcast here