The FDA has granted startup Vascular Perfusion Solutions (San Antonio, Tex.) breakthrough device designation for its VP.S Encore oxygenated perfusion cardiac transport device.
Organs available for transplant can remain viable for only four to six hours, which severely limits the travel distance to waiting recipients. In the U.S. alone there are now more than 110,000 men, women and children on the national waiting list who hope to receive an organ transplant. Unfortunately, more than half of all donated organs are rejected because they cannot reach patients in time.
Vascular Perfusion Solutions’ patent-pending technology uses oxygen to enable the preservation of vascularized tissue for at least eight hours. As a self-contained device, VP.S Encore offers portability (fits in the overhead compartment of a commercial airliner), affordability and ease of use, according to the company.
While the VP.S Encore device is focused initially on heart transport, it will later be extended to other organs, such as kidneys, livers, and lungs. It also will provide a platform for future uses, such as skin growth for burn victims, according to the company.
“We are thrilled that our VP.S Encore device has received a breakthrough device designation,” said Leonid Bunegin, chief scientific officer at VPS, in a news release. “VPS now has the priority to interact more quickly with the FDA, moving us closer to bringing VP.S Encore and its lifesaving technology to patients across the country, and eventually, the world.”
Original Article: (http://feedproxy.google.com/~r/MedicalDesignAndOutsourcing/~3/b8c4Z8tA-24/)