TyRx Antibacterial Envelope for Implantable EP Devices Receives Health Canada Approval
October 12, 2012 — TyRx Inc. said it received a license from Health Canada to market its AigisRx Antibacterial Envelope. The AigisRx Envelope is specifically designed to stabilize pacemakers and implantable cardioverter defibrillators (ICDs) while also releasing antimicrobial agents to help provide protection from microbial colonization of the device during surgical implantation.
“We are very excited about bringing the AigisRx technology to the Canadian market in order to help reduce patient morbidity, mortality and health care system costs related to CIED infections,” said Robert White, TyRx president and chief executive officer.
The AigisRx Envelope is primarily intended to hold the pacemaker or ICD securely in place in order to provide a stable environment when implanted in the body. Additionally, the AigisRx contains the antimicrobial agents rifampin and minocycline, which are released over a seven to 10 day period, in order to help provide protection from microbial colonization of the device during surgical implantation.
The AigisRx Envelope is FDA-cleared in the United States and has been implanted in well over 25,000 patients since its commercial release.
TyRx is currently evaluating distribution partners for its launch of the AigisRx Envelope into the Canadian market and will be exhibiting at the Canadian Cardiovascular Congress in Toronto (Oct. 27 to 30).
For more information: www.tyrx.com