MONMOUTH JUNCTION, N.J., Oct. 16 (UPI) -- TyRx Pharma said Monday it has filed for U.S. approval of a mesh pouch designed to stop bacterial colonization of implanted devices.
The company said its PIVIT CRM is made from a mesh material coated with a bioresorbable polymer that contains the antibacterial drugs rifampin and minocycline, which fits around a pacemaker or implantable cardioverter defibrillator (ICD) when placed in the body.
The pouch is intended to protect against microbial colonization of the device's pulse generator during surgical implantation, TyRx Pharma said, noting that the infection rate for pacemakers is 5.82 percent and 3.71 percent for ICDs, based on 2003 statistics.
"With over 500,000 annual implants of pulse generators, we believe PIVIT CRM will become a valuable tool in the effort to suppress microbial colonization of pulse generators during surgical implantation," said Bill Edelman, chief executive officer of TyRx Pharma. "This is the third in a series of combination medical products that TyRx will launch this year for PIVIT CRM."
