Neomend, a provider of sealant and adhesion-prevention products for the surgical marketplace, has received premarket approval from the FDA for its ProGEL Pleural Air Leak Sealant, a lung surgery device.
ProGEL is a hydrogel polymer sealant consisting of two components like human serum albumin and a cross-linking component of polyethylene glycol. When they are mixed together, a rapid reaction occurs that creates a hydrogel matrix that results in the formation of a strong, adherent and flexible seal, said the company.
ProGEL is intended for application in visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (=2 mm) incurred during open resection of lung parenchyma.
The company claims that the FDA approval came following a multi-center clinical study on the device that encompasses 161 patients in five institutions: Mayo Clinic, Cedars-Sinai Medical Center, Duke University, MD Anderson Cancer Center, and the University of Washington.
ProGEL was shown to be 77% effective in sealing air leaks intra-operatively, compared to 16% for the control group. The device led to a reduction in both intraoperative air leaks and hospital stay of nearly two days.
The newly available device addresses a current, unmet surgical need to seal pleural air leaks incurred during the lung surgery. The company estimates that approximately 150,000 lung resections are performed in the US every year. Intraoperative air leaks are a primary complication of lung surgery and can lead to other complications such as infections, pneumonia and extended hospitalization.
David Renzi, president and CEO of Neomend, said: “We are excited to receive this approval and be in a position to provide this technology to the surgeons and patients who greatly need it. This technology has also been shown to reduce hospital stay days, a benefit that can significantly reduce the total cost of these procedures to the hospital. Neomend will move quickly to bring this important product to market.”