GlobeNewswire10.22.18
Matrix Surgical USA, a company focused on the development, manufacturing, and commercialization of craniomaxillofacial implants, announced today that it has received a 510(k) clearance to market its OmniPore DUROMAX Surgical Implants, which are intended for non-weight-bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery, and repair of maxillofacial and orbital trauma.
The DUROMAX orbital implant builds upon the previously cleared high-density polyethylene craniofacial implant platform by adding a commercially pure titanium construct embedded inside the porous polyethylene framework. The titanium has the advantage of shape retention after manipulating by hand and is radiopaque on post-operative computer tomography (CT) scans, unlike regular porous polyethylene implants without embedded titanium. The implants are for single use only and have a five-year shelf life.
According to John O’Shaughnessy, founder and CEO of Matrix Surgical USA, “The addition of DUROMAX to our ever-expanding line of craniofacial implants fills an important void in our portfolio.” O'Shaughnessy added, “We are very pleased with the response from the initial panel of surgeons who have evaluated DUROMAX and are eager to incorporate them into their clinical practice.”
Additional variants of DUROMAX are currently in development and are expected to be launched in early 2019 in markets where the company has regulatory clearances.
The DUROMAX orbital implant builds upon the previously cleared high-density polyethylene craniofacial implant platform by adding a commercially pure titanium construct embedded inside the porous polyethylene framework. The titanium has the advantage of shape retention after manipulating by hand and is radiopaque on post-operative computer tomography (CT) scans, unlike regular porous polyethylene implants without embedded titanium. The implants are for single use only and have a five-year shelf life.
According to John O’Shaughnessy, founder and CEO of Matrix Surgical USA, “The addition of DUROMAX to our ever-expanding line of craniofacial implants fills an important void in our portfolio.” O'Shaughnessy added, “We are very pleased with the response from the initial panel of surgeons who have evaluated DUROMAX and are eager to incorporate them into their clinical practice.”
Additional variants of DUROMAX are currently in development and are expected to be launched in early 2019 in markets where the company has regulatory clearances.