The device represents an innovative approach as a self-expanding biodegradable ASD occluder.The novel Pansy metal-free occluder shows promising efficacy and safety for managing atrial septal defect (ASD) in adults and children in a recent Chinese study.
“Our 12-month follow-up data [show the noninferiority of the experimental device to] conventional nitinol occluders in terms of efficacy and safety during the short-term postoperative period,” the investigators said.
Both experimental and conventional devices achieved a 100-percent closure success rate at 6 months postop, with no moderate-to-large residual shunts (>5 mm) detected at 1, 3, 6, and 12 months. [Cardiovasc Interv Ther 2026;41:1161-1172]
Of the eight patients in the investigational group who had minor residual shunts (<5 mm) at 6 months, two had shunts >2 mm. At 12 months, one completely resolved, while the other’s size remained stable. “The residual shunts … did not significantly impact clinical symptoms, and all patients maintained normal chamber sizes without haemodynamic significance. No complications related to residual shunting were reported during follow-up,” the researchers noted.
Safety
There were no serious device-related complications, including mid to large residual shunts and new arrhythmias, in both groups at all follow-up timepoints.
Seven and four patients in the respective experimental and control groups experienced headache events, but most were infrequent. One patient in the control group reported frequent transient headaches 1 month postop which, according to the researchers, may have been due to a microthrombus. Nonetheless, the events resolved completely after adding clopidogrel to the patient’s routine aspirin therapy.
Eleven serious adverse events (SAEs) were reported during follow-up. SAEs that required hospitalization or diagnostic evaluation (fevers, fractures, early pregnancy termination, thyroid malignancy) were deemed unrelated to the device.
One patient was hospitalized 1 month postop due to recurrent fever secondary to infective endocarditis. This was managed with vegetation resection, occluder removal, and surgical ASD repair, and was deemed unrelated to the experimental device.
Suitable for adults, children
Nickel release and compression effects associated with nitinol-based occluders can lead to serious complications, such as allergic reactions, cardiac perforation, and concurrent atrial fibrillation. [Dermatitis 2019;30:213-221; JACC Cardiovasc Interv 2021;14:e49-e51; Pediatr Cardiol 2020;41:54-61]
Complications are typically managed by transcatheter interventions, which require transseptal puncture via the femoral vein to access the left atrium. “However, [this] poses significant challenges in patients with a pre-existing ASD occluder in place,” the researchers noted.
To address the limitations of nondegradable devices, biodegradable occluders have become a promising alternative, they added.
The Pansy occluder comprises a polydioxanone (PDO) mesh framework, a polyethylene terephthalate membrane, and polyamide sutures. According to the researchers, the elasticity and self-expanding properties of the PDO structure “mitigates the [high incidence] of residual shunts associated with biodegradable occluders and enables a delivery and release process similar to that of metal occluders.”
The complete degradability of the PDO framework also alleviates other long-term complications tied to traditional metal occluders (eg, metal hypersensitivity, chronic inflammation), which may offer significant advantages, especially in paediatric patients.
Despite the need for continued surveillance of the explanted case and the minor residual shunts in the study, “the device represents an innovative approach as a self-expanding biodegradable ASD occluder and is offered in various sizes suitable for both adults and children,” the researchers said.
A total of 112 patients were randomized 1:1 to a biodegradable (mean age 18.35 years, 54.4 percent female) or conventional occluder (mean age 20.42 years, 72.7 percent female). Seventy-one patients were <18 years. In the experimental group, the mean defect size was 8.48 mm, and the mean occluder size was 13.62 mm. In the control group, the corresponding measurements were 10.41 mm and 15.88 mm, respectively.