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reSept ASD Occluder implanted in EU for the first time

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French TV France3 reported on the first patients implanted with a reSept ASD Occluder in France and in the European Union at Bordeaux University Hospital. The coverage includes video interviews with young patient Léo and his mother, and with the doctors that treated him, as part of the ASCENT ASD trial.

Professor Jean-Benoît Thambo, head of the department of pediatric and congenital cardiology at the Bordeaux University Hospital, said to France3 how “these prostheses are the first phase of the medicine of tomorrow, a medicine that opts for material adapted to the body, biological”.

As interventional cardiologist Zakaria Jalal explained to France3, “with time and healing, the components of the prosthesis will be digested by the body, the patient will eventually carry very few foreign bodies within his body.”

The successful procedure is reported to have lasted for fifteen minutes and that Léo was expected to return home the next day.

The investigational reSept ASD Occluder is also being studied in the US under an FDA approved protocol.

For the English translation, click here

For the original article in French, click here

For the original video interview in French, click here

FDA Approved Second Phase of ASCENT ASD

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atHeart Medical has received approval for the start of the second phase of its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial.

The prospective, single-arm study is 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.

“I am pleased the first phase of enrollment in our pivotal trial progressed smoothly and according to plan, this is an exciting milestone for the company,” said Laurent Grandidier, CEO of atHeart Medical. “As we initiate the second phase, our team is focused on adding clinical sites across the U.S. and expanding internationally to include several enrolling sites in France. I commend the team’s diligence to further validating the safety and efficacy of the reSept ASD Occluder, a critical step in our journey to evolve septal closure and provide a better solution for patients.”

Read full press release

Mathilda has a special heart

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The story of the first patient implanted with a reSept ASD Occluder in Switzerland has been reported in Forschungs-Magazin, the research magazine by Children’s Hospital Zurich, where Mathilda’s intervention took place.

In a heartfelt recollection, Mathilda’s family shared their journey from diagnosis, through to coronavirus and travel restrictions, to the operation with a novel device with a metal-free frame, and the welcomed, normal life that followed. “Once she got back home, there was nothing to indicate that she had just had a heart operation. Mathilda was alert and started school two weeks later,” Mathilda’s mother remembered in the article.

Forschungs-Magazin also interviewed Professor Oliver Kretschmar, Chief Physician and Co-Head of the Cardiology Department at the University Children’s Hospital Zurich, and Professor of Paediatric Cardiology at the University of Zurich, who implanted Mathilda.

Professor Kretchmar explained in the magazine how minimally invasive implants tend to be ideal options for young patients. “The best implant is not an implant. If it fulfils its purpose, closes the hole and then largely dissolves and the body’s own tissue grows over the hole, that’s fantastic,” he stated.

Read the English translation of the article

Read the original article in German

Andrew Cleeland joins atHeart Medical’s Board

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atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced the appointment of Andrew Cleeland to the company’s Board of Directors. With over thirty years of experience, including specific expertise bringing game-changing technologies to market, Mr. Cleeland joins as the company builds momentum for the ASCENT ASD U.S. investigational device exemption (IDE) trial studying the safety and efficacy of its reSept™ ASD Occluder technology.

“I am excited to join atHeart’s board and work with the company to evolve septal closure. The company’s next-generation, metal-free, bioresorbable frame design is a novel approach in the structural heart space,” said Mr. Cleeland. “Unlike current competitive metallic frame occluders, the reSept occluder resorbs over time to restore a more natural septum and leaves minimal metal behind, a significant benefit for patients who may require future transseptal interventions.”

Mr. Cleeland is currently the CEO of Fogarty Innovation, a leading nonprofit focused on visionary approaches that address unmet needs in an evolving medtech landscape. Prior to joining Fogarty, Mr. Cleeland served as vice president and general manager at Medtronic following the acquisition of Twelve Inc., which he led as CEO.

He currently serves on the board of three venture-funded companies, Saluda Medical, Zenflow, Inc. (chairman) and MMI S.p.A. (chairman). Mr. Cleeland also holds advisory positions at two top-tier venture capital firms, Longitude Capital and Arboretum Ventures. At a global industry level, he has been invited to serve on multiple initiatives including the UCSF-Stanford Pediatric Device Consortium, the Medical Device Innovation Consortium, and the Singapore government’s Biomedical Research Council (BMRC).

“Andrew is a proven medtech leader with a strong passion for championing novel healthcare solutions,” commented Laurent Grandidier, CEO of atHeart Medical. “His wealth of knowledge and business expertise will be critical in guiding our strategic plan as we accelerate the IDE trial and prepare for future milestones.”

First Five Patients Successfully Treated

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atHeart Medical announced today the successful treatment of the first five patients in its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial. This study, the company’s first in the US, will evaluate the safety and efficacy of the reSept ASD Occluder.

The initial patients were treated by Dr. Thomas Jones, Cardiac Catheterization Laboratory Director at Seattle Children’s Hospital (Seattle, WA), Dr. Scott Lim, Medical Director of the Advanced Cardiac Valve Center at the University of Virginia (Charlottesville, VA) and Dr. Thomas Forbes, Director of Cardiac Catheterization Laboratory at Children’s Hospital of Michigan (Detroit, MI). The prospective, single-arm study will enroll up to 250 patients at multiple sites globally. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD occluders.

“I am pleased to be a part of this study and advance therapy options for septal defects that leave a minimal footprint behind. The reSept ASD Occluder implanted easily and had a successful outcome with no residual shunts,” commented Dr. Jones. “We look forward to continuing enrollment and further validation of this promising technology.”

atHeart Medical has commenced operations

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atHeart Medical announced today that it has commenced operations and is initiating its U.S. Investigational Device Exemption (IDE) trial.
The company is led by seasoned global medtech executive, Laurent Grandidier, with support from an exceptional management team that has decades of experience with medical device start-ups and major corporations.

AtHeart Medical’s first product, the reSept ASD Occluder, is the first occluder with a metal-free, bioresorbable frame. The novel implant is poised to overcome the limitations of current occluders, as it aims to reduce the risk of complications associated with the long-term presence of metal in the heart and to preserve future treatment options requiring transseptal intervention. Initial clinical experience demonstrates long-term clinically effective closure of the ASDs treated with the company’s device.1Company Data on File.

“I am excited to lead atHeart Medical and for the potential of our first product, the reSept ASD Occluder, for patients requiring ASD closure,” commented Laurent Grandidier, CEO of atHeart Medical. “With such an experienced team, we have hit the ground running and are focused on preparing initial clinical sites in our U.S. IDE pivotal trial.”

Read the full press release here.

Beginning with a purpose

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I couldn’t be more enthusiastic about our purpose at atHeart Medical: allowing more future options for patients with atrial septal defects (ASDs) by reducing device footprint.

Our first product, the reSept ASD Occluder, is the first occluder with a metal-free, bioresorbable frame.

We are focusing on preparing initial clinical sites for our U.S. IDE pivotal trial, the FDA-approved ASCENT ASD study.

We want to expand the promising data from initial clinical experience, to establish the new standard of care for the closure of ASDs – a congenital condition affecting six in 10,000 births.

I am excited to lead atHeart Medical’s incredibly experienced team, as we hit the ground running.

Thank you for following us from our very first steps in this exciting new journey.

 

Laurent Grandidier
CEO, atHeart Medical