Xeltis completes enrollment for feasibility study of tissue growth device in children

Xeltis announced that it has completed enrollment for a feasibility study of an implantable device intended to cause the spontaneous growth of natural heart valves and vessels in children with congenital heart defects.

The device is the company’s first product, and is a synthetic matrix designed to serve as a replacement pulmonary valve by growing natural tissue within the body, according to a press release. As valves and vessels develop, the device biodegrades over time without leaving foreign material in the body, reducing the need for long-term medication or repeat surgery. The product is intended to serve as a “one-time, definitive treatment” that does not require the use of external stem cells or products derived from animals, according to the release.

The first-in-human study, conducted at the Bakoulev Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences in Moscow, includes five patients with single-ventricle heart physiology. Follow-up at 3 months after the first implantation of the device has been positive, according to the release, with reports of increased mobility and activity in the initial recipient.

“The Xeltis technology is very exciting because it holds the promise to enable [endogenous tissue growth] for the first time,” Leo Bockeria, MD, cardiac surgeon at the Bakoulev Center for Cardiovascular Surgery, said in the release. “If proven valid, this therapy will finally end the tragic cycle of repeat surgery and lifelong medication that these children and their families must currently endure. This will not only alleviate pain and suffering for families, it will save billions of healthcare dollars each year.”