Positive six-month results with a Novel Biosynthetic Tissue Valve

A study looking at the safety and performance of a new pulmonary valved conduit provided "encouraging clinical results."

The novel Biosynthetic Tissue Valve is from W. L. Gore & Associates, which also conducted the feasibility study over six months on 16 patients, the company said in a release posted to PRNewswire.com on Nov. 30.

The age of the Early Feasibility Study subjects was 6 to 17 years old, with seven males and nine females had various forms of underlying congenital heart disease, which required replacement of the pulmonary valve and right ventricular outflow tract (RVOT), the release said.

"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," Mark Galantowicz, M.D., the presenting investigator and Chief of Cardiothoracic Surgery and co-director of The Heart Center at Nationwide Children's Hospital in Columbus, Ohio said in the release.

A composite of independence from valve-related mortality and device-related reintervention at six months was a success in all patients, the release said. There was also no presence of calcification and/or endocarditis discovered on the valves or conduits. Subjects will be monitored on a clinical basis, and there will be yearly echocardiograms for up to five years.

"These early results are quite encouraging and indicate patients, especially pediatric patients who have traditionally needed multiple open replacements of traditional biologic tissue valves, may soon have a new option available," Galantowicz said in the release.

The data from this study will be sent to the FDA for future consideration of studies similar to this, with the potential of commercial approval, the release said.