Hingham, MA (PRWEB) December 09, 2014
Phase One Medical, LLC., a medical device company specializing in the development of venous access products, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Symetrex™ Long Term Hemodialysis Catheter indicated for hemodialysis and apheresis.
The Symetrex™ is a reversible, low recirculation catheter (less than 1% recirculation in forward and reverse flow*) that has been designed to self-stabilize while in use and to minimize wall-suction while achieving high flow rates. Unique to Symetrex™, the tip design does not require an extended septum, a port offset, or turbulent vectoring to achieve low recirculation in either flow direction. By leveraging U.S. manufacturing expertise, the fit and finish of the product creates a new quality standard for central venous catheters.
In addition, the Symetrex™ Long term Hemodialysis catheter design will offer the market the smallest functional distal tip providing the implanting physician easier device placement within the right atrium. The unique green luers and product branding on the central hub provide the access technician an external indication of reversibility, thereby allowing the lines to be reversed as needed without fear of loss of efficiency due to recirculation.
The commercialization of Symetrex™ Long term Hemodialysis Catheter will complete Phase One Medical’s transformation from a seasoned technology licensing entity to a products company. By leveraging its R&D infrastructure and strong pipeline, Phase One Medical will quickly expand its product portfolio.
“We are pleased with the recent FDA 510(k) clearance of Symetrex™ Long Term Hemodialysis Catheter and we are eager to introduce this technology into the marketplace. Symetrex™ has the opportunity to make a significant and positive contribution to hemodialysis patients requiring long term venous access,” commented Adrian Ravenscroft, President of Phase One Medical.
Phase One Medical is currently seeking domestic and international distributors to represent Phase One Medical’s product portfolio. Phase One Medical is anticipating commercial release of Symetrex™ by April, 2015.
Phase One Medical, LLC., based in Hingham, MA., is a privately held medical device company specializing in the development, manufacturing, and marketing of minimally invasive medical devices targeted towards central venous access, interventional radiology, nephrology, and oncology markets.
Phase One Medical, LLC
Adrian Ravenscroft, President & CEO
- when tested in-vitro