Healthcare Industry News: albumin
News Release - January 9, 2012
Progel(R) Extended Tip Receives FDA Approval
The Only Sealant Designed Specifically for Thoracic Surgeons Now Offers Even Better AccessIRVINE, Calif.--(Healthcare Sales & Marketing Network)-- Neomend, Inc., a leading innovator in sealant and adhesion-prevention products for the surgical marketplace, said it has received premarket approval (PMA) from the U.S. Food and Drug Administration for use of the company’s new Progel® Extended Applicator Spray Tip.
The Progel Extended Applicator Spray Tip is a single-use medical device designed to be used with the Progel Pleural Air Leak Sealant. The new commercially available applicator is designed to deliver the only FDA approved pleural air leak sealant in the U.S. The Extended Applicator Spray Tip, which is available in two sizes, provides an additional delivery option when used as indicated during an open thoracotomy.
The new spray tip is intended to deliver Progel to visceral pleura during an open thoracotomy after surgeons use sutures or staples to close visible air leaks (> 2 mm) incurred in the visceral pleura during open resection of lung parenchyma. By bending the device’s flexible tip, surgeons can direct Progel from the delivery tip in a stream or spray pattern to the targeted surface.
“The Extended Applicator Spray Tip makes applying Progel more convenient for thoracic surgeons,” said David Renzi, the company’s President and CEO. “With the longer, malleable tip they will be able to conveniently reach areas that might previously have been harder to access. The ability to position the delivery applicator spray tip provides an advantageous option for the surgeon in applying Progel easily and accurately.”
Air leaks are the number-one complication associated with pulmonary surgery, and when left untreated can lead to additional complications and morbidity. “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,” said Renzi.
Progel Pleural Air Leak Sealant was evaluated in a prospective, randomized, controlled multi-center trial and demonstrated significantly improved clinical outcomes. Published data shows that when used as indicated, Progel can effectively seal intraoperative air leaks, significantly reduce postoperative air leaks, reduce hospital length of stay, minimize associated complications and morbidities and provide incidental cost-of-care savings.
Progel Pleural Air Sealant has been used in the treatment of more than 27,000 patients in the U.S. alone since the product received PMA approval from the FDA in January 2010. Progel Pleural Air Leak Sealant is part of a line of unique hydrogel sealants to be commercialized by Neomend.
A second product, Progel Platinum Surgical Sealant, a recombinant version of the pleural air sealant, received the CE mark in January 2011 and was launched in the EU last June. Progel® Platinum Surgical Sealant is a hydrogel polymer consisting of two components: a biocompatible synthetic protein of recombinant albumin (Albucult®*) and a cross-linking component of polyethylene glycol (PEG). Albucult® ralbumin USP-NF is a product of Novozymes Biopharma UK Ltd. and Novozymes Biopharma DK A/S.
The Extended Applicator Tip is also CE marked and has been available in the EU since June 2011. In addition, Progel® Adhesion Barrier sealant used in abdominal and pelvic surgeries, received CE Mark in December 2011.
About Neomend, Inc.
Neomend, based in Irvine, Calif., is a leading innovator in sealant and adhesion-prevention products for the surgical marketplace focused on the design, development and commercialization of innovative surgical sealants and adhesion prevention products derived from the Progel technology platform. These products are designed to enhance existing standards of care and inspire confidence in surgical technique; to provide uncomplicated solutions that improve each patient’s healthcare experience; and to reduce cost-of-care in hospitals and medical facilities worldwide. The company holds 29 issued patents in chemical composition and delivery applicators. For more information, visit www.Neomend.com or call 949.916.1630.
About Progel® Technology Platform
The Progel technology platform is a resorbable hydrogel with a unique, accessible molecular structure that makes it ideal for development of novel medical devices like surgical sealants and adhesion barriers. The first commercial product from this platform technology in the U.S., Progel®Pleural Air Sealant, received FDA approval in January, 2010 and is the only commercially available and FDA-approved pleural air leak sealant in the U.S. As the only available sealant designed specifically for sealing lung air leaks Progel Pleural Air Leak Sealant has compelling clinical results that show a significant reduction in postoperative air leaks and a reduction in inpatient length of stay. Additional products including Progel Platinum Surgical Sealant and Progel Adhesion Barrier (AB) have received CE marks and are currently distributed in Europe.
Source: Neomend
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