U.S. FDA Grants Breakthrough Device Designation to Vascular Perfusion Solutions for its Visionary VP.S Encore™ Cardiac Transport Device
SAN ANTONIO, Texas--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device Designation for its groundbreaking VP.S Encore™ oxygenated perfusion cardiac transport device.
The patent-pending technology uses oxygen to enable preserving vascularized tissue for eight hours, and more, doubling the viability of organs beyond the current standard of care. As a self-contained device, VP.S Encore™ provides portability (fits in the overhead compartment of a commercial airliner), affordability, and ease of use.
“We are thrilled that our VP.S Encore™ device has received a breakthrough device designation. 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,” said Leonid Bunegin, Chief Scientific Officer at VPS.
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. Presently, organs available for transplant can remain viable for only 4 to 6 hours, which severely limits the travel distance to waiting recipients.
The FDA created the Breakthrough Device Designation program to provide patients and health care providers with timely access to lifesaving medical devices by expediting their development and prioritizing their assessment and review. VPS received the designation in recognition of its effort to transform the world of organ preservation, resuscitation, and transport by removing the obstacles of time and distance with the creation of VP.S Encore™.
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.
About Vascular Perfusion Solutions (VPS)
Vascular Perfusion Solutions, Inc. is a development and early-stage company, formed for the purpose of commercializing new, unique, and innovative oxygenated perfusion, preservation, and resuscitation solutions for the body’s organs, limbs and other vascularized tissue. Visit www.vascularperfusion.solutions to learn more.
Marcie Casas, GDC