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Paragonix Technologies Inc., Announces Filing of a Second 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

Mon, 11/18/2013 - 6:00am
Business Wire

Paragonix Technologies, Inc. today announced that it has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport System 1,2 (CTS). The Sherpa Pak CTS is indicated for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart. The current pre-market notification application intends to further identify user indications for the static hypothermic preservation of hearts during transportation.

Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, “We are thrilled to have filed the second Pre-Marketing Notification Application (510(k)) with FDA for the Sherpa Pak™ CTS. Following excellent market reaction to our first 510(k) cleared product, we anticipate significant clinical interest for this innovative technology in the markets where the Sherpa Pak™ CTS will be cleared for commercial distribution. This is the second in a series of regulatory applications while we continue our development of several additional Sherpa CTS products.” Previous Announcements Paragonix previously announced on July 22, 2013, Publication by the ASAIO (American Society for Artificial Internal Organs) Journal of "Oxygen Consumption during Oxygenated Hypothermic Perfusion as a Measure of Donor Organ Viability." Paragonix previously announced on June 10, 2013, Presentation of "An Innovative, Novel Hypothermic Storage System For Donor Hearts," discussing the Sherpa Pak™ Cardiac Transport System during the 16th Congress of the European Society for Organ Transplantation held in Vienna, Austria, 8th – 11th September 2013.

Paragonix previously announced on February 12, 2013, clearance of a 510(k) pre-marketing notification application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System.

Paragonix previously announced on July 16, 2012, award of a Phase I Small Business Innovation Research (SBIR) Grant to support the pre-clinical development of the Paragonix Sherpa™ Cardiac Transport in collaboration with the Transplant Center at Massachusetts General Hospital (Boston).

Paragonix previously announced on June 25, 2012, Appointment of Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC as Chief Medical Officer.

Paragonix previously announced on June 18, 2012, Formation of a Clinical Advisory Board for the Paragonix Sherpa™ Cardiac Transport System.

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