Abbott Secures FDA Approval for First Transcatheter Paravalvular Leak Treatment Device

The US Food and Drug Administration (FDA) has granted approval to Abbott for its Amplatzer Paraclose Occluder, establishing it as the first transcatheter device specifically cleared in the US market for the treatment of paravalvular leak (PVL). Paravalvular leak is a medical complication that occurs when a gap forms between a replacement heart valve and the surrounding heart tissue, allowing blood to flow backward around the valve.

Understanding Paravalvular Leak and Current Limitations

According to the American Heart Association (AHA), PVL affects between 2% and 18% of patients following heart valve replacement surgery or transcatheter valve procedures. The exact incidence rate depends on whether the valve is located in the aortic or mitral position and whether it was implanted surgically or via catheter.

Severe cases of paravalvular leak can lead to symptoms commonly associated with heart failure, such as shortness of breath, as well as severe anaemia. When medications such as diuretics or vasodilators prove ineffective, patients historically required revision heart surgery. However, major repeat open-heart procedures carry significant procedural risks, creating a distinct demand for less invasive alternatives.

Minimally Invasive Intervention via Catheter Technology

The newly approved Amplatzer Paraclose Occluder offers a minimally invasive alternative designed to address PVL without requiring another major operation. The device is implanted through a catheter that is inserted via an artery or a vein in the leg, allowing physicians to navigate to the heart and close the gap around the replacement valve.

Sandra Lesenfants, senior vice president of Abbott structural heart business, noted that the device fills a critical gap for clinicians. Previously, physicians treating PVL in the US lacked an approved alternative to repeat open-heart surgery. Lesenfants emphasized that the occluder builds upon the company portfolio of structural heart devices intended to treat cardiovascular conditions while helping patients avoid surgical complications.

Clinical Study Data Supporting Approval

Regulatory approval for the Amplatzer Paraclose Occluder was supported by data from Abbott PARADIGM study, registered under the clinical trials identifier NCT04489823. Findings from this trial demonstrated that the device provides a safe and effective alternative to repeat open-heart surgery for eligible patients experiencing paravalvular leaks.

While newly authorized in the United States, the device has an established commercial history in other regions. It has been available in Europe since 2020, where it is marketed under the name Amplatzer Valvular Plug III.

Broader Abbott Structural Heart Portfolio

The Amplatzer Paraclose Occluder joins several other cardiovascular and structural heart tools within Abbott device portfolio. Other notable products in this line include:

• The Piccolo Occluder, which received FDA approval in January 2019 for patent ductus arteriosus closure in premature infants.
• The Talisman patent foramen ovale (PFO) occluder, approved in September 2021 to close small flap-like openings between the upper heart chambers that fail to seal properly after birth.

With the addition of the Amplatzer Paraclose Occluder to the US market, clinicians now have an authorized transcatheter option to manage complex paravalvular leaks and potentially reduce the frequency of invasive revision surgeries for vulnerable cardiac patients.