The US Food and Drug Administration (FDA) has granted premarket approval for Neomend's new Progel extended applicator spray tip, designed specifically for thoracic surgeons.
The Progel extended applicator spray tip is a single-use medical device for use in conjunction with the Progel pleural air leak sealant, and is available in two sizes.
The new spray tip will deliver Progel to visceral pleura during an open thoractomy after surgeons use sutures or staples to close visible air leaks incurred in the visceral pleura during open resection of lung parenchyma.
The device's flexible tip enables surgeons to direct Progel from the delivery tip in a stream or spray pattern to the targeted surface, and provides an additional delivery option when used as indicated during an open thoracotomy.
Neomend president and CEO David Renzi said that the product will allow surgeons will to conveniently reach areas that might previously have been harder to access. He added that the ability to position the delivery applicator spray tip provides an advantageous option for the surgeon in applying Progel easily and accurately.
"Because Progel is the only sealant designed specifically for thoracic surgeons, it is important to provide additional delivery choices that add to this technological advancement for patients," Renzi said.
Prior studies have shown that Progel can effectively seal intraoperative air leaks, reduce postoperative air leaks, reduce hospital length of stay, minimise associated complications and morbidities and provide incidental cost-of-care savings.
US-based Neomend, an innovator in sealant and adhesion-prevention products for the surgical marketplace is focused on the design, development and commercialisation of innovative surgical sealants and adhesion prevention products derived from the Progel technology platform.
The Progel technology platform is a resorbable hydrogel with a unique, accessible molecular structure that makes it suitable for the development of novel medical devices such as surgical sealants and adhesion barriers.