TyRx Pharma, Inc. has recently submitted a Premarket Application for PIVIT™ CRM, an innovative mesh pouch coated with a proprietary bioresorbable polymer containing the antimicrobial agents, rifampin and minocycline, designed to enclose a pacemaker or ICD pulse generator when implanted in the body.
According to University of Pittsburgh Medical Center, in 2003 alone, the national incident of infection for pacemakers was estimated to be 5.82% and for ICDs 3.71%.
PIVIT™ CRM is designed to provide protection from microbial colonization of the pulse generator during surgical implantation.
According to Bill Edelman, CEO of TyRx Pharma:
"We are extremely excited to have reached this value-creating milestone with the filing of a Premarket 510(k) Application for PIVIT™ CRM.
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.
This is the third in a series of combination medical products that TyRx will launch this year.
The USFDA has granted 510(k) clearance in July 2006 for PIVIT™ AB, TyRx's Antimicrobial Surgical Mesh coated with rifampin and minocycline and in December 2005, a 510(k) clearance for PIVIT™, TyRx's 1st bioresorbable polymer coated surgical mesh product.
Find more details from the TyRx press release (a pdf file).
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