Over the last 2 months Massachusetts medtech startup has Paragonix Technologies filed 2 more 510(k) applications in efforts to win U.S. marketing approval for its Sherpa line of heart and kidney transportation systems.
The device maker this week announced 510(k) filing for its Sherpa Pak Transporter for hypothermic preservation of kidneys during transportation, following last month’s filing for Sherpa Pak Cardiac Transport System. Other Sherpa products are also in development, the company noted.
Paragonix’s technologies use a system of "cold perfusion," providing expanded organs with an oxygenated solution that can help preserve vital tissue for many hours longer than the standard Igloo-style coolers more commonly used to transport organs on their way to transplant patients.
The heart transport systems have met with "excellent market reaction" since their FDA clearance earlier this year, and the company expects "significant clinical interest" for the kidney transport system once it hits the market, Paragonix co-founder and COO Lisa Anderson said in prepared remarks.
"I have devoted many decades to the science and clinical aspects of kidney transplantation. There has been, and continues to be, a persistent shortage of organs suitable for transplantation. Improvements in kidney preservation methods would greatly benefit the field," Harvard Medical School professor and Massachusetts General Hospital transplantation department Chief Emeritus Dr. A. Benedict Cosimi said on behalf of the company. "I am excited, therefore, to see advances such as these reach the pre-market submission stage."
The company in February won initial FDA clearance for its Sherpa Pak CTS for "static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart." The new FDA bid aims to expand that clearance to include additional user indications, according to a press release.
