EVOLVING SEPTAL
CLOSURE

EVOLVING SEPTAL CLOSURE

Less metal, more options for the future

Less metal, more options for the future

The reSept™ ASD Occluder is the first occluder with a metal-free frame designed for the closure of atrial septal defects.

CLINICAL DATA

EVOLVING
SEPTAL CLOSURE

Less metal, more options for the future

The reSept™ ASD Occluder is the first and only occluder with a metal-free frame designed for the closure of atrial septal defects.
CLINICAL DATA

1.https://www.cdc.gov/ncbddd/heartdefects/atrialseptaldefect.html

Hole in the heart

ASD hole size

S = Small, M = Medium, L = Large

DEFECTS VARY IN SIZE AND POSITION

  • Very small defects may be found by chance and may never cause a problem.
  • Some may close on their own during childhood.
  • Medium and large defects may require a medical procedure to be closed.

When ASDs require closure, the current standard of care is to have an atrial septal occluder implanted through a minimally invasive procedure, which does not require opening the heart. However, open heart surgery may be required in some cases, based on the size and position of the defect.

ASCENT-ASD

ATRIAL SEPTAL OCCLUDERS HELP CLOSE DEFECTS

  • The occluder is introduced in the body by a catheter, through a small incision in the groin, and positioned in the heart.
  • Once in place, the occluder opens up like an umbrella on each side of the hole and locks together to seal it and prevent abnormal blood flow between the upper chambers of the heart.

Septal occluders have enabled minimally invasive treatment; however, currently available options have limitations because of their bulky, dense metal frames. 
The long-term presence of a metal frame in the heart may lead to potential complications and may limit future interventions that require a physician to cross the septum.

Heart defect

ATRIAL SEPTAL DEFECT (ASD)

Commonly referred to as "hole in the heart"

An ASD is an opening in the wall, or septum, that separates the two upper chambers of the heart, called the left atrium and right atrium. An ASD occurs when the septum does not form or close properly.

  • Most are present at birth.
  • Affects nearly six in 10,000 births.1
  • Can result from an interventional procedure that requires crossing the septum, such as a mitral valve repair.

ATRIAL SEPTAL DEFECT (ASD)

Commonly referred to as "hole in the heart"

Heart defect

An ASD is an opening in the wall, or septum, that separates the two upper chambers of the heart, called the left atrium and right atrium. An ASD occurs when the septum does not form or close properly.

  • Most are present at birth.
  • Affects nearly six in 10,000 births.1
  • Can result from an interventional procedure that requires crossing the septum, such as a mitral valve repair.
Heart defect
ATRIAL SEPTAL DEFECT (ASD)

Commonly referred to as "hole in the heart"

An ASD is an opening in the wall, or septum, that separates the two upper chambers of the heart, called the left atrium and right atrium. An ASD occurs when the septum does not form or close properly.

  • Most are present at birth.
  • Affects nearly six in 10,000 births.1
  • Can result from an interventional procedure that requires crossing the septum, such as a mitral valve repair.
Atrial septal defect

ATRIAL SEPTAL DEFECT (ASD)

Commonly referred to as "hole in the heart"

An ASD causes oxygen-rich blood to mix in the oxygen-poor chamber, which would not otherwise occur. This can increase blood flow to the lungs.

  • Patients may experience shortness of breath, fatigue, and palpitations.
  • Over time, the increased blood flow may lead to high blood pressure, arrhythmia, heart failure or an increased risk of stroke.1

ATRIAL SEPTAL DEFECT (ASD)

Commonly referred to as "hole in the heart"

Atrial septal defect

An ASD causes oxygen-rich blood to mix in the oxygen-poor chamber, which would not otherwise occur. This can increase blood flow to the lungs.

  • Patients may experience shortness of breath, fatigue, and palpitations.
  • Over time, the increased blood flow may lead to high blood pressure, arrhythmia, heart failure or an increased risk of stroke.1
Atrial septal defect

ATRIAL SEPTAL DEFECT (ASD)

Commonly referred to as "hole in the heart"

An ASD causes oxygen-rich blood to mix in the oxygen-poor chamber, which would not otherwise occur. This can increase blood flow to the lungs.

  • Patients may experience shortness of breath, fatigue, and palpitations.
  • Over time, the increased blood flow may lead to high blood pressure, arrhythmia, heart failure or an increased risk of stroke.1
LESS METAL, MORE OPTIONS

The reSept™ ASD Occluder is the first device with a metal-free, bioresorbable frame. This novel device aims to overcome the limitations of current ASD treatment options and offers the potential to:

  • Help reduce the risk of complications due to long-term presence of bulky metal in the heart.
  • Enable future interventions that may not otherwise be possible due to metal barriers.
LESS METAL, MORE OPTIONS
The reSept ASD Occluder is the first and only device with a metal-free, bioresorbable frame. This novel device aims to overcome the limitations of current ASD treatment options and offers the potential to:
  • Help reduce the risk of complications due to long-term presence of bulky metal in the heart.
  • Enable future interventions that may not otherwise be possible due to metal barriers.
LESS METAL, MORE OPTIONS
The reSept™ ASD Occluder is the first and only device with a metal-free, bioresorbable frame. This novel device aims to overcome the limitations of current ASD treatment options and offers the potential to:
  • Help reduce the risk of complications due to long-term presence of bulky metal in the heart.
  • Enable future interventions that may not otherwise be possible due to metal barriers.
The reSept ASD Occluder
features bioresorbable filaments connecting two polyester fabric patches
Closure

How it works

  1. The reSept™ ASD Occluder is inserted in the heart via a catheter from a small incision in the groin.

  1. Once in the heart, its two fabric patches are positioned on each side of the hole in the septum.

  1. The patches are then pulled together and locked, closing the ASD.

  1. As tissue grows around the device and permanently seals it to the septum, the reSept ASD Occluder's filaments begin to resorb, eventually leaving the sealed patches behind.

  • Watch how the reSept ASD Occluder works

RESULTS SO FAR

First In Human Study: Nine adult patients have been implanted with our ASD Occluder and had their ASDs successfully closed. The first patient was implanted over five years ago. The study was conducted in Germany.

European Registry: Six patients, including four children, have been implanted with our ASD Occluder and had their ASDs successfully closed. The first patient was implanted in March 2020. The registry was conducted in Germany and Switzerland.

ASCENT-ASD
Investigational device exemption (IDE) U.S. trial

atHeart Medical has initiated a pivotal trial in the United States to demonstrate the safety and efficacy of its reSept ASD Occluder for treating patients with clinically significant, isolated ASD.

For more information about the study and participating hospitals, please visit clinicaltrials.gov (NCT04591392).

RESULTS SO FAR

First In Human Study: Nine adult patients have been implanted with our ASD Occluder and had their ASDs successfully closed. The first patient was implanted over five years ago. The study was conducted in Germany.

European Registry: Six patients, including four children, have been implanted with our ASD Occluder and had their ASDs successfully closed. The first patient was implanted in March 2020. The registry was conducted in Germany and Switzerland.

ASCENT-ASD investigational device exemption (IDE) U.S. trial

atHeart Medical has initiated a pivotal trial in the United States to demonstrate the safety and efficacy of its reSept ASD Occluder for treating patients with clinically significant, isolated ASD.

For more information about the study and participating hospitals, please visit clinicaltrials.gov (NCT04591392).

atHeart Medical

Our mission is to establish the first transcatheter ASD occluder with a metal-free frame as the new standard of care for atrial septal defects (ASDs).

Based in Switzerland and in the U.S., we have assembled an exceptional team with decades of experience at medical device start-ups and major corporations.

We have initiated our ASCENT-ASD pivotal trial in the United States and internationally to demonstrate the safety and efficacy of our reSept ASD Occluder for treating patients with clinically significant, isolated ASD. Our reSept ASD Occluder has received Investigational Device Exemption approval from the U.S. FDA.

Our company was founded by the Olle Larsson Holding AG (OLH), a Swiss corporate group with a diverse portfolio of companies, including medical devices, and a long-standing commitment to improve children’s health.