Occlutech Atrial Flow Regulator (AFR)Perfecting Flow

A cardiac implant designed to address the unmet medical needs of patients suffering from heart failure (HF) despite optimal medical therapy. 

Implanted on the interatrial septum of the heart using routine, minimally invasive procedures.

Intended to permanently maintain the interatrial communication (shunt) created by Balloon Atrial Septostomy (BAS). This shunt allows for the controlled flow of blood from the left,- to the right atrium.

The Occlutech Atrial Flow Regulator (AFR) is a cardiac implant designed to address the unmet needs of patient suffering from heart failure (HF), despite optimal medical therapy.

The small implantable device is made of Nitinol, a material used widely in implantable cardiac devices, and placed on the interatrial septum of the heart using routine, minimally invasive procedures.

Occlutech has over 16 years of experience in making Nitinol-based cardiac implants and we developed the AFR with the aim to provide an innovative and minimally invasive (nonsurgical), treatment alternative to address the unmet medical needs of HF patients.

Once implanted, the Occlutech Atrial Flow Regulator is intended to permanently maintain the interatrial communication created by Balloon Atrial Septostomy (BAS). Per the HF indication, this shunt allows for the controlled flow of blood from the left atrium to the right atrium. The resulting decompression of the left atrium is expected to lead to reduced symptoms.

The Occlutech Atrial Flow Regulator has not received FDA Premarket Approval or been licensed by Health Canada. 

How heart failure patients benefit from atrial shunts

PRELIEVE 1-YEAR RESULTS5

Occlutech Atrial Flow Regulator (AFR). The shunt allows the controlled blood flow from the left to the right atrium. The ensuing left atrial decompression is expected to improve symptoms, exercise tolerance and quality of life.5
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Product Instructions
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Material and design characteristics

  • Implanted using standard transcatheter techniques1
  • Allows for the controlled flow of blood from the left to the right atrium1, 2
  • Expected to lead to reduced symptoms, improved exercise tolerance and quality of life1, 2, 3, 4

 Compatibility chart & ordering information

Download for AFR with OPP
Download for AFR with FP II

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Content references:
  1. Paitazoglou, Christina, and Martin W. Bergmann. “The atrial flow regulator: current overview on technique and first experience.” Therapeutic Advances in Cardiovascular Disease 14 (2020): 1753944720919577.
  2. Case Report: Chirillo, F. et al. Left Atrial Decompression as Palliative Therapy for Heart Failure Patients with Preserved Ejection Fraction. 4, 5 (2020)
  3. Case Report: Lewicki, Ł., Sabiniewicz, R., Siebert, J. & Szołkiewicz, M. Atrial flow regulator as a novel therapy for patients with chronic heart failure.
  4. Case Report: Kudret Aytemir, U. N. K. Decompression of the left heart chambers via atrial flow regulator: A new insight into heart failure treatment.
  5.  Bergmann M.W. et al PRELIEVE – The Occlutech AFR: Matching shunt length and diameter to the patient, THT 2023.
Not approved or available for sale in the United States. Product(s) may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Occlutech representative if you have questions about the availability of Occlutech products in your area.

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