Adapta Medical gets US FDA marketing approval for urinary catheter, PerfIC Cath
Adapta Medical, Inc. has received FDA market release for the PerfIC Cath intermittent touchless urinary catheter. The sterile catheter system was designed by J. Glen House, MD, a C7 quadriplegic with limited finger dexterity.
FDA clearance for the PerfIC Cath will result in Adapta expanding the PerfIC Cath product line and launching the new mPower Cath series catheter product line. Both product lines feature hydrophilic and gel lubricants for straight and coude-tipped catheters. The PerfIC Cath catheters have an attached urine collection bag while the mPower Cath products have a urine collection bag that is not attached to the catheter.
"The PerfIC Cath catheter represents a significant advancement in intermittent catheter technology and is extremely easy to use, even with limited dexterity," said House. "It is designed for those with a spinal cord injury, multiple sclerosis, diabetes, stroke, spina bifida or other conditions that require a catheter, but can be used easily by those with normal hand dexterity too. It is created for users by users." With a variety of patents, the catheters are truly unique and offer a new experience for catheter users.
Key features shared by the PerfIC Cath and mPower Cath intermittent urinary catheters include An easy-open package, gripping device and unique sheath that makes self-cathing easy, even with limited dexterity; A patented gripping device and hydrophilic coating to ensure even and complete catheter lubrication with easy passage into the bladder; An introducer tip, which bypasses high levels of bacteria to reduce the risk of infection; A cleaner experience. The catheters are enclosed in a protective sheath that keeps fluid from touching the user, nearly eliminating mess and ensuring easy disposal.