Gore has announced encouraging clinical results from its early feasibility study evaluating the safety and performance of its pulmonary valved conduit, an investigational device. Six-month data for 16 patients enrolled across three sites in the USA were presented in a moderated poster session during the American Heart Association virtual scientific sessions (AHA 2020, 13 – 17 November, virtual).
Patients ranged in age from six‒17 years old with an average age of 11.5±3.7 years old. There were seven males and nine females with various forms of underlying congenital heart disease requiring operation for initial or repeat replacement of the pulmonary valve and right ventricular outflow tract (RVOT). The primary endpoint, a composite of freedom from valve-related mortality and device related reintervention at six months, was successfully achieved in all patients. In addition, there was no calcification and/or endocarditis detected on the valves or conduits and excellent haemodynamic performance was demonstrated. Subjects will be followed clinically and with yearly echocardiograms up to five years to further assess longer term performance. Data from this study will be submitted to the US Food and Drug Administration (FDA) to support future consideration of a pivotal investigational device exemption study, potentially leading to commercial approval.
“As has been demonstrated in the literature, current treatment options using biologic tissue leaflets for these procedures have very high failure and reintervention rates particularly in younger patients,” said Mark Galantowicz, the presenting investigator and Chief of Cardiothoracic Surgery and co-director of The Heart Center at Nationwide Children’s Hospital, Columbus, USA. “These early results are quite encouraging and indicate patients, especially paediatric patients who have traditionally needed multiple open replacements of traditional biologic tissue valves, may soon have a new option available.”
The EFS evaluated Gore’s Pulmonary Valved Conduit device in patients whose native pulmonary valve or previously repaired RVOT required replacement or reconstruction with a valved conduit. Patients in need of RVOT reconstruction are most often younger patients and have underlying complex congenital heart defects. If left untreated, native pulmonary valve regurgitation or progressive RVOT obstruction typically leads to shortness of breath, lower quality of life and damage to the right ventricle. Even after effective initial replacement, many patients with these conditions will undergo multiple open-heart surgeries for replacement of failed or outgrown conduits throughout their childhood and teenage years. Early conduit failure necessitates additional conduit replacements which further contribute to the adverse effects of the underlying disease on quality of life and long-term survival.