Paragonix Technologies, a medical device manufacturer based in Cambridge, recently completed its 510(k) pre-marketing application with the United States Food and Drug Administration for one of its flagship products, the Paragonix Sherpa Pak Cardiac Transport System (PSPCTS). The PSPCTS is intended to increase the amount of time a donor heart can be kept alive by 300 percent.

According to the company, the cold storage device can be used to deliver oxygen-rich blood to organs while in transport. Traditional donor organ transplant systems can keep an organ alive for approximately four hours. With the new PSPCTS system, it may be possible to keep donor organs like the heart alive for up to 12 hours.

Paragonix has received assistance from some outside investors. According to reports filed by the company, Paragonix received a $1 million grant from the National Heart, Blood and Lung Institute. This Small Business Innovation Research (SBIR) grant provided the company valuable capital to continue its research. In addition, the company received a $710,000 grant from the Ma. Life Sciences Center.

In prepared remarks, COO and president Lisa M. Anderson stated, “We are thrilled to have reached the milestone of filing the Pre-Marketing Notification Application 510(k) with FDA for the Sherpa Pak CTS.” She continued, “We anticipate significant clinical interest for this innovative technology in the markets where the Sherpa Pak CTS will be cleared for commercial distribution.”

References

http://www.masshightech.com/stories/2012/11/05/daily16-Paragonix-files-w...