The U.S. Food and Drug Administration has approved Abbott’s Amplatzer Paraclose PVL Occluder. The device closes leaks that develop around surgically replaced heart valves. It is the first transcatheter product specifically approved in the United States for this condition.
Abbott announced the decision on October 28. Amplatzer Paraclose gives eligible patients another option when a leak requires treatment after valve replacement. Rather than reopening the chest, physicians can deliver the implant through a catheter.
The condition is called paravalvular leak, or PVL. It occurs when blood flows through a gap between a replacement valve and the heart’s surrounding tissue. Such gaps may appear soon after surgery or develop years later.
Abbott estimates that PVL occurs in 7% to 17% of surgical mitral valve replacements. It estimates a 5% to 10% rate for aortic valve replacements. Significant leaks may cause breathlessness, fatigue and swelling. They can also damage red blood cells, sometimes causing severe anaemia.
How Amplatzer Paraclose Closes Heart Valve Leaks
During treatment, a physician places a catheter into an artery or vein in the leg. The physician then guides the implant to the affected valve. Once positioned inside the gap, it helps block abnormal blood flow.
Amplatzer Paraclose has an oblong shape designed for irregular openings. Some paravalvular leaks are elongated or crescent-shaped rather than circular. The design aims to close these defects without interfering with the replacement valve.
Amar Krishnaswamy, an interventional cardiologist at Cleveland Clinic, discussed the device’s elliptical shape in Abbott’s announcement. He said the shape could accommodate different leak sizes and configurations. The goal is to help suitable patients avoid another operation.
The treatment is not intended for every patient with PVL. Abbott’s device safety information limits use to clinically significant leaks around surgical aortic or mitral valves. Doctors must review valve stability, opening size, and available vascular access.
Amplatzer Paraclose is contraindicated in several situations, including active endocarditis and certain unstable replacement valves. Exclusions also cover defects involving more than half the valve’s perimeter. Do not use the device when the defect’s short axis exceeds 5 mm.
Catheter treatment avoids another open-chest procedure, but it is not risk-free. Potential complications include bleeding, device movement, stroke and interference with valve function. The risks depend on the patient’s condition and the procedure.
PARADIGM Trial Supports FDA Approval
Abbott’s PARADIGM clinical study supported the FDA decision. The investigation examined the safety and effectiveness of Amplatzer Paraclose in patients with clinically significant leaks.
The study’s main details include:
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Enrollment: 200 patients at 24 medical sites worldwide.
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Design: Prospective, multicenter, international and single-arm.
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Patients: People with mechanical or biological replacement valves in the aortic or mitral position.
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Condition: Moderate or more severe leaks associated with serious symptoms or complications.
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Measures: Implant success, procedural safety, leak reduction and additional interventions.
Because PARADIGM was a single-arm study, participants were not randomly assigned to a repeat-surgery group. Its findings therefore cannot establish whether the implant works better than another operation. Abbott said the evidence supported the approval but initially released limited numerical results.
The studied patients had more than an incidental leak detected during routine imaging. The protocol focused on clinically significant defects accompanied by heart failure symptoms or hemolysis. These enrollment criteria help explain the approved treatment population.
According to MedTech Dive, Abbott planned to present 30-day PARADIGM results at the Transcatheter Cardiovascular Therapeutics conference in San Diego. Those data could provide a clearer view of early outcomes. Longer follow-up will also matter for assessing durability and repeat procedures.
Abbott Expands Its Cardiac Device Portfolio
Amplatzer Paraclose is already marketed outside the United States as the Amplatzer Valvular Plug III. Europe has approved the technology for paravalvular leak treatment since 2020. The new FDA decision establishes its U.S. indication for leaks around surgical replacement valves.
Abbott’s Amplatzer family also includes devices for other heart conditions. The Piccolo Occluder treats certain congenital heart defects. The Talisman PFO Occluder helps reduce recurrent stroke risk in selected patients. Abbott also markets the Amulet implant to close the left atrial appendage.
Other manufacturers are expanding catheter-based heart valve care. Edwards Lifesciences recently received FDA approval for its PASCAL Precision tricuspid valve repair system. That device treats leakage through a native tricuspid valve. Amplatzer Paraclose instead addresses a gap beside a previously implanted surgical valve.
Abbott also recently received FDA approval for new CardioMEMS features. CardioMEMS monitors pulmonary artery pressure and helps clinicians manage heart failure. Unlike the closure implant, it does not repair a structural valve leak.
Abbott has not announced U.S. pricing or a detailed commercial rollout schedule for Amplatzer Paraclose. Its use will depend on clinical selection, physician expertise and access to the procedure. Additional PARADIGM results may help hospitals evaluate the device’s early performance.
