Georgia medical device maker CorMatrix touted an FDA win this month, landing regulatory clearance for its CanGaroo surgical envelope for securing implantable cardiac devices.
The FDA cleared the envelope for use in creating a stable environment inside the body for implanting cardiac devices such as pacemakers and defibrillators. The device is a cellular matrix derived from porcine tissue and comes in 4 sizes, according to the CorMatrix announcement.
The company won FDA clearance on the strength of its pre-clinical testing, which showed that the envelope helped the body create its own vascularized tissue pouch that also facilitated later removal of the devices.
"The CorMatrix CanGaroo was designed to address the needs described to us by physicians implanting [cardiac implantable electronic devices] in their daily practice," sales & marketing executive vice president John Davis said in prepared remarks."We are pleased that we can provide a device that our physicians requested to address complications with CIED implantation."
Just days after announcing the FDA win, the company also reported that the 1st human procedure took place at Ohio’s Cleveland Clinic.